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  1. 510(k) Clearances

March 2021 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2021


DEVICE: Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
Maxstar Industrial Co., Ltd.      510(k) NO: K191441(Traditional)
ATTN: Jonghwa  Lim                PHONE NO : 82 31 9893543 
152 - 12 Hwanggeum-ro 23beon-gil, SE DECISION MADE: 05-MAR-21
Gimpo  KR 415843                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endo Motor
Foshan CICADA Dental Instrument Co510(k) NO: K192649(Traditional)
ATTN: Juan  Liu                   PHONE NO : 86 757 85775667 
B5-2F, Guangdong New Light Source SE DECISION MADE: 12-MAR-21
Nanhai District, Foshan  CN       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIDA Wearable Neuromodulation System
Exodus Innovations                510(k) NO: K192731(Traditional)
ATTN: Isaac  Oppenheim            PHONE NO : 347 9540624 
1 Exodus Road                     SE DECISION MADE: 19-MAR-21
Sufa  IL 85457                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FloPump 57mL Centrifugal Pump
International Biophysics Corporati510(k) NO: K193663(Traditional)
ATTN: Geoff  Marcek               PHONE NO : 512 8140046 
2101 E. St. Elmo Road             SE DECISION MADE: 10-MAR-21
Austin TX  78744                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Low-frequency Multi-function physiotherapy instrument
Shenzhen Kentro Medical Electronic510(k) NO: K200177(Traditional)
ATTN: Zewu  Zhang                 PHONE NO : 86 755 33825998 
No.3, Xihu industry zone, Xikeng VSE DECISION MADE: 25-MAR-21
Longgang District,Shenzhen City  C510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Myriad Particles
Aroa Biosurgery Ltd.              510(k) NO: K200502(Traditional)
ATTN: Tina  O'Brien               PHONE NO : 64 09 8693035 
2 Kingsford Smith Place           SE DECISION MADE: 31-MAR-21
Airport Oaks  NZ 2022             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LumiCare Caries Diagnostic Rinse
GreenMark Biomedical Inc.         510(k) NO: K200601(Third Party - Traditional)
ATTN: Steven  Bloembergen         PHONE NO : 517 8963665 
325 E. Grand River Ave., Suite 314SE DECISION MADE: 29-MAR-21
East Lansing MI  48823            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Compressible Limb and Circulation Therapy System
Wonjin Mulsan Co., Ltd            510(k) NO: K200660(Traditional)
ATTN: Ha Yong Jung                PHONE NO : 82 32 8160552 
Seo-gu                            SE DECISION MADE: 08-MAR-21
Incheon  KR 22653                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clarus Peel-Away Introducer Sheath
Clarus Medical, LLC               510(k) NO: K200925(Traditional)
ATTN: Mark F. Brown               PHONE NO : 763 5258445 
13355 10th Ave N Suite 110        SE DECISION MADE: 18-MAR-21
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Modulith SLX-F2
KARL STORZ Endoscopy America      510(k) NO: K201001(Traditional)
ATTN: Winkie  Wong                PHONE NO : 424 2188379 
2151 E Grand Avenue               SE DECISION MADE: 30-MAR-21
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sovereign America Surgical Face Mask
HomTex, Inc.                      510(k) NO: K201095(Abbreviated)
ATTN: Jeremy  Wootten             PHONE NO : 256 7343937 
2125 2nd Avenue SW                SE DECISION MADE: 19-MAR-21
Cullman AL  35055                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruAbutment DS, TruBase S
TruAbutment Inc.                  510(k) NO: K201197(Traditional)
ATTN: Eunjin  Jang                PHONE NO : 714 9561488 
17742 Cowan                       SE DECISION MADE: 26-MAR-21
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode Evolve System with the Tone Applicator
InMode Ltd.                       510(k) NO: K201285(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 05-MAR-21
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANAM Test System
Vista LifeSciences, Inc.          510(k) NO: K201376(Traditional)
ATTN: Margaret E. Molloy          PHONE NO : 888 7338804 1
7375 S. Peoria St. Suite 210      SE DECISION MADE: 25-MAR-21
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VENUS Bracket, ROSE Bracket
GNI Co., LTD                      510(k) NO: K201410(Traditional)
ATTN: Duk Soo Kim                 PHONE NO : 82 505600 8880 
5F 501, 63-12 DongtancheomdansaneoSE DECISION MADE: 12-MAR-21
Hwaseong  KR 18469                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Republic Spine Dark Star Spinal System
Republic Spine, LLC               510(k) NO: K201420(Traditional)
ATTN: James  Doulgeris            PHONE NO : 561 3342421 
2424 N Federal Hwy, STE 257       SE DECISION MADE: 05-MAR-21
Boca Raton FL  33431              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arisure Closed System Drug Transfer Device (CSTD)
Yukon Medical, LLC                510(k) NO: K201422(Traditional)
ATTN: Pamela  McNulty             PHONE NO : 919 5958253 
4021 Stirrup Creek Dr Ste 200     SE DECISION MADE: 02-MAR-21
Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyCRO Band
Otto Bock Healthcare LP           510(k) NO: K201426(Traditional)
ATTN: Caleb  Beck                 PHONE NO : 801 9746647 
3820 West Great Lakes Drive       SE DECISION MADE: 26-MAR-21
Salt Lake City UT  84120          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Groshong NXT PICC Catheter
C.R. Bard, Inc.                   510(k) NO: K201452(Traditional)
ATTN: Matthew  Lyman              PHONE NO : 801 5225416 
605 North 5600 West               SE DECISION MADE: 12-MAR-21
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tranberg CLS Laser Applicator
Clinical Laserthermia Systems, AB 510(k) NO: K201466(Traditional)
ATTN: Lars-Erik  Eriksson         PHONE NO : 46 461 52100 
Scheelevägen 2                    SE DECISION MADE: 26-MAR-21
Lund  SE 22381                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile Zirconia Block
Bioden Co., Ltd                   510(k) NO: K201492(Traditional)
ATTN: MyeongEun  Song             PHONE NO : 82 2629 22840 
#B-803 119, Gasan Digital 1-ro, GeSE DECISION MADE: 10-MAR-21
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Dongguan Prestige Sporting Goods C510(k) NO: K201508(Traditional)
ATTN: Zhang  Zhao                 PHONE NO : 86 1376 3128800 
3rd Industrial, Qiaotou Area, HoujSE DECISION MADE: 09-MAR-21
Dongguan  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
AVINENT Implant System S.L.U.     510(k) NO: K201533(Traditional)
ATTN: Anna  Cortina               PHONE NO : 00 34 902383848 
Pol. Ind. Santa Anna              SE DECISION MADE: 01-MAR-21
Santpedor  ES 08251               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CPR BAND
CREDO                             510(k) NO: K201581(Traditional)
ATTN: Ji Hyo Wang                 PHONE NO : 82 33 7668901 
#302, 86, Baeul-ro                SE DECISION MADE: 06-MAR-21
Wonju-si  KR 26465                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMMA Capnograph
Masimo Corporation                510(k) NO: K201590(Special)
ATTN: Katelynn  Kirby             PHONE NO : 949 2977000 
52 Discovery                      SE DECISION MADE: 29-MAR-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
Schoelly Fiberoptic GmbH          510(k) NO: K201617(Traditional)
ATTN: Sandra  Baumann             PHONE NO : 0049 766 6908357 
Robert-Bosch-Strasse 1-3          SE DECISION MADE: 12-MAR-21
Denzlingen  DE 79211              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spin Care Disposable Protective Mask
SpinTech LLC                      510(k) NO: K201624(Traditional)
ATTN: Jim  Jean                   PHONE NO : 704 9293596 
1920 Flintstone Drive             SE DECISION MADE: 18-MAR-21
Statesville NC  28677             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Subcutaneous Infusion Set
Epic Medical Pte. Ltd.            510(k) NO: K201626(Traditional)
ATTN: Freddie  Lee                PHONE NO : 
105 Cecil Street #20-04 The OctagoSE DECISION MADE: 24-MAR-21
Singapore  SG 069534              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RG 3ml Medication Cartridge
Chengdu Shifeng Medical Technology510(k) NO: K201634(Traditional)
ATTN: Nick  Wang                  PHONE NO : 086 028 8245916 
No. 31, Yinyuan Road              SE DECISION MADE: 26-MAR-21
Jinhua Town, Xinjin County  CN 611510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cultura Collection and Transport System
Merit Medical Systems, Inc        510(k) NO: K201674(Traditional)
ATTN: Alex  Bohorquez             PHONE NO : 801 2084685 
1600 West Merit Parkway           SE DECISION MADE: 03-MAR-21
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iCE-SG Subcutaneous Electrode Arrays
iCE Neurosystems, Inc.            510(k) NO: K201678(Traditional)
ATTN: Allen  Waziri               PHONE NO : 646 2509166 
1875 Connecticut Ave NW, Suite 121SE DECISION MADE: 08-MAR-21
Washington DC  20009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgical Mask
Hangzhou Mycode Bio-Medicine Co., 510(k) NO: K201698(Traditional)
ATTN: Alice  Gong                 PHONE NO : 86 571 87329869 
Floor 4, Building No. 4, No. 2 XiySE DECISION MADE: 15-MAR-21
Hangzhou  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
Fisher & Paykel Healthcare Ltd.   510(k) NO: K201723(Traditional)
ATTN: Reena  Daken                PHONE NO : 64 5740100 
15 Maurice Paykel Place, East TamaSE DECISION MADE: 16-MAR-21
Auckland  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AllerBlock Junior
Nasaleze International Ltd        510(k) NO: K201734(Traditional)
ATTN: Matt  Duxbury               PHONE NO : 44 0 1624611050 
Old Castletown Road               SE DECISION MADE: 26-MAR-21
Douglas  IM Im2 1qa               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVision ICE Catheter
NuVera Medical, Inc.              510(k) NO: K201775(Traditional)
ATTN: Robert  Nardelli            PHONE NO : 951 9991230 
140 Knowles Dr.                   SE DECISION MADE: 05-MAR-21
Los Gatos CA  95032               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
Baxter Healthcare Corportation    510(k) NO: K201809(Traditional)
ATTN: Kristen  Bozzelli           PHONE NO : 224 9485585 
25212 W. Illinois Route 120       SE DECISION MADE: 10-MAR-21
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask-Model Number: Ear Loop, Flat-Pleated
Huizhou Foryou Medical Devices Co.510(k) NO: K201852(Abbreviated)
ATTN: Guosheng  Tan               PHONE NO : 86 0752 5302185 
No. 1 Shangxia North Road, DongjiaSE DECISION MADE: 02-MAR-21
Huizhou  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovaLine Tubing Sets for Hemodialysis
Bain Medical Equipment(Guangzhou) 510(k) NO: K201866(Traditional)
ATTN: Zoe  Zeng                   PHONE NO : 86 20 66856868 290
No.10, Juncheng Road, Eastern AreaSE DECISION MADE: 10-MAR-21
Guangzhou  CN 510760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ST-Z5
Z-Systems AG                      510(k) NO: K201878(Traditional)
ATTN: Rubino  DiGirolamo          PHONE NO : 41 62388 6969 
Werkhofstrasse 5                  SE DECISION MADE: 25-MAR-21
Oensingen  CH ch-4702             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer Model T103, T104
Bioland Technology Ltd.           510(k) NO: K201879(Traditional)
ATTN: Yiqing  Feng                PHONE NO : 86 755 36900999 
No. A6B7 (Block G) ShangRong IndusSE DECISION MADE: 31-MAR-21
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ritleng®+ and Ritleng®+ PVP
FCI (France Chirurgie Instrumentat510(k) NO: K201892(Traditional)
ATTN: Thierry  Fetick             PHONE NO : 33 153 989898 
20-22 rue Louis Armand            SE DECISION MADE: 11-MAR-21
Paris  FR 75015                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
IOB Medical Inc                   510(k) NO: K201896(Traditional)
ATTN: Jiulin  Xia                 PHONE NO : 301 2500831 
504E Diamond Ave., Suite I        SE DECISION MADE: 30-MAR-21
Gaithersburg MD  20877            510(k) STATEMENT
                                                    

DEVICE: Spacelabs Lifescreen PRO Analyzer
Spacelabs Healthcare Ltd.         510(k) NO: K201921(Traditional)
ATTN: Roger  Moldon               PHONE NO : 011 44 1992507730 
Unit B, Foxholes Centre, John TateSE DECISION MADE: 26-MAR-21
Hertford  GB SG13 7DT             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single-Use Surgical Mask
Qiqihar Hengxin Medical Supplies, 510(k) NO: K201924(Traditional)
ATTN: Sihui  Xiong                PHONE NO : 86 452 5656959 
10th Beijiang Road in Tiefang InduSE DECISION MADE: 15-MAR-21
Qiqihar  CN 161000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Getinge GSS610N Series Steam Sterilizer
Maquet GmbH                       510(k) NO: K201927(Traditional)
ATTN: Holger  Ullrich             PHONE NO : 49 722 29321550 
Kehler Strasse 31                 SE DECISION MADE: 01-MAR-21
Rastatt  DE 76437                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A8, A9 Anesthesia System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K201957(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81888998 
Mindray Building, Keji 12th Road SSE DECISION MADE: 26-MAR-21
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
Chison Medical Technologies Co., L510(k) NO: K201965(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 0086 510 85311707 
No.228, Changjiang East Road, BlocSE DECISION MADE: 02-MAR-21
Wuxi  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single-use medical face mask
Guangdong Horigen Mother & Baby Pr510(k) NO: K201974(Traditional)
ATTN: Jun  Deng                   PHONE NO : 086 0754 83613668 
Block A&B&C, NCBC Industrial Park,SE DECISION MADE: 07-MAR-21
Shantou  CN 515100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: miha bodytec II
Miha Bodytec Gmbh                 510(k) NO: K201975(Traditional)
ATTN: Felix  Schweigert           PHONE NO : 49 821 45549222 
Siemensstr. 1                     SE DECISION MADE: 11-MAR-21
Gersthofen  DE 86368              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air compression therapy system FO-3001; Air compression therapy system FO-3008
Foshan Hongfeng Co., Ltd          510(k) NO: K201982(Traditional)
ATTN: Cheng  Dongfeng             PHONE NO : 086 0757 8392028 
No.4-2 Leqiang Road, Leping SanshuSE DECISION MADE: 25-MAR-21
Foshan  CN 528000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026
Shenzhen Juzhong Technology Co., L510(k) NO: K202009(Traditional)
ATTN: Chang  Lihua                PHONE NO : 0086 755 27764799 
Block B, floor 3, building 38, SanSE DECISION MADE: 22-MAR-21
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: White ENDOSEAL MTA
Maruchi                           510(k) NO: K202015(Traditional)
ATTN: Sung Wook Jang              PHONE NO : 82 33 7340330 
2-208, Medical Industry Complex BlSE DECISION MADE: 24-MAR-21
Wonju-si  KR 26311                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
Hill-Rom, Inc.                    510(k) NO: K202018(Traditional)
ATTN: Jigar  Shah                 PHONE NO : 1 201 2841024 
1069 State Route 46 East          SE DECISION MADE: 04-MAR-21
Batesville IN  47006              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: imani i2
imani Co.                         510(k) NO: K202037(Traditional)
ATTN: Hyo-Soon  Hwang             PHONE NO : 82 31 3234435 
1F, Na Dong, 19, Wanjangcheon-ro 3SE DECISION MADE: 01-MAR-21
Yongin-si  KR 17117               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: wheezo WheezeRate Detector
Respiri Limited                   510(k) NO: K202062(Traditional)
ATTN: Samaneh  Sarraf             PHONE NO : 61 491 208783 
Level 10, 446 Collins Street      SE DECISION MADE: 11-MAR-21
Melbourne  AU 3000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeedleSmart Professional (NS Pro)
NeedleSmart Limited               510(k) NO: K202073(Traditional)
ATTN: Tom  Baker                  PHONE NO : 44 0151 3150516 
Suite 2B, Stanley Grange Business SE DECISION MADE: 25-MAR-21
Knowsley, Prescot  GB L34 5NB     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
Shen Wei USA Inc.                 510(k) NO: K202076(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 05-MAR-21
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
Shen Wei USA Inc.                 510(k) NO: K202078(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 05-MAR-21
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
Shen Wei USA Inc.                 510(k) NO: K202080(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 24-MAR-21
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
Shen Wei USA Inc.                 510(k) NO: K202081(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 19-MAR-21
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
Shen Wei USA Inc.                 510(k) NO: K202082(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 17-MAR-21
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Shen Wei USA Inc.                 510(k) NO: K202083(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 25-MAR-21
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors
Shen Wei USA Inc.                 510(k) NO: K202086(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 16-MAR-21
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Ceragem Automatic Thermal Massager, Model CGM-MB-1901
Ceragem Co, Ltd.                  510(k) NO: K202113(Traditional)
ATTN: Hyeonggeun  Hwang           PHONE NO : 
10, Jeongja 1-Gil, Seonggeo-Eup, SSE DECISION MADE: 02-MAR-21
Cheonan-Si  KR 31041              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Century Perfusion System
Century HLM, LLC                  510(k) NO: K202125(Traditional)
ATTN: Jeff  Poland                PHONE NO : 1 314 4975232 
3110 N. Oakland, STE 101          SE DECISION MADE: 07-MAR-21
Mesa AZ  85215                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Mask
Hangzhou Qianzhiya Sanitary Produc510(k) NO: K202133(Traditional)
ATTN: Yu  Shao                    PHONE NO : 86 571 69910779 
No.88 Fengwang Road, Economic DeveSE DECISION MADE: 25-MAR-21
Hangzhou  CN 311500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable medical mask
U-Play Products Corporation       510(k) NO: K202137(Traditional)
ATTN: Jin  Jing                   PHONE NO : 86 553 8516886 
No.7, Fumin Road, Jiujiang EconomiSE DECISION MADE: 04-MAR-21
Wuhu  CN 241000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Hunan EEXI Technology & Service Co510(k) NO: K202161(Traditional)
ATTN: Zhang  Xianliang            PHONE NO : 0086 1587 4115252 
No.6 North of Pingtou Road, LiuyanSE DECISION MADE: 10-MAR-21
Liuyang  CN 410300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Senhance Surgical System
TransEnterix, Inc.                510(k) NO: K202166(Traditional)
ATTN: Kaitlyn  Alexander          PHONE NO : 1 919 7658400 8505
635 Davis Drive, Suite 300        SE DECISION MADE: 02-MAR-21
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrueRelief Device
TrueRelief                        510(k) NO: K202186(Traditional)
ATTN: John  Crosson               PHONE NO : 310 9189064 
100 Wilshire Boulevard, Suite 700 SE DECISION MADE: 23-MAR-21
Santa Monica CA  90401            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
Wuhan Zonsen Medical Products Co.,510(k) NO: K202191(Traditional)
ATTN: Shirly  Xi                  PHONE NO : 86 158 27495791 
Chengbei Industry Zone, Zhucheng ASE DECISION MADE: 29-MAR-21
Wuhan  CN 431000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Jiangsu Micsafe Medical Technology510(k) NO: K202205(Traditional)
ATTN: Tony  Yang                  PHONE NO : 86 13 651929266 
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 09-MAR-21
Yancheng  CN 224125               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IFM Surgical Mask Model SM3
FSSC, LLC                         510(k) NO: K202214(Third Party - Traditional)
ATTN: Clayton  Geyer              PHONE NO : 219 8638316 
3300 West Clark St.               SE DECISION MADE: 02-MAR-21
Rensselaer IN  47978              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Oncospace
Oncospace, Inc.                   510(k) NO: K202284(Traditional)
ATTN: Praveen  Sinha              PHONE NO : 608 2396871 
1812 Ashland Ave., Suite 100k     SE DECISION MADE: 12-MAR-21
Baltimore MD  21205               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
Optellum Ltd                      510(k) NO: K202300(Traditional)
ATTN: David  Arrowsmith           PHONE NO : 44 7542 006599 
Oxford Centre for Innovation, New SE DECISION MADE: 05-MAR-21
Oxford  GB OX1 1BY                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical mask (Model: KKF-1A)
Han Zhaoqing Sporting Goods Compan510(k) NO: K202316(Traditional)
ATTN: Zhang  Ming                 PHONE NO : 86 138 25518595 
NO.2-1, Kang tai Street, High-techSE DECISION MADE: 03-MAR-21
Zhaoqing  CN 526238               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
Kanglongda Vietnam Protection Tech510(k) NO: K202356(Traditional)
ATTN: Lu  Lingfeng                PHONE NO : 84 234 3888189 
Lot CN 05, Viglacera-Phong Dien InSE DECISION MADE: 02-MAR-21
Phong Dien  VN 535041             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZOLL Propaq M
ZOLL Medical Corporation          510(k) NO: K202375(Traditional)
ATTN: Elizabeth  McMeniman        PHONE NO : 978 5696862 
269 Mill Road                     SE DECISION MADE: 09-MAR-21
Chelmsford MA  01824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invacare AVIVA Storm RX Power Chair
Invacare Corporation              510(k) NO: K202379(Traditional)
ATTN: Elijah  Wreh                PHONE NO : 440 3296840 
One Invacare Way                  SE DECISION MADE: 19-MAR-21
Elyria OH  44035                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves (Blue, Violet Blue, White)
Jiangsu Tianshuo Medical Products 510(k) NO: K202402(Traditional)
ATTN: Gao  Feng                   PHONE NO : 86 152 03225200 
No. 78, North Longjin Road, SuchenSE DECISION MADE: 01-MAR-21
SuQian  CN 223800                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
Allmed Medical Products Co., Ltd. 510(k) NO: K202409(Traditional)
ATTN: Vince  Tian                 PHONE NO : 86 717 4211111 
No. 99, Jin Shan Road, Majiadian TSE DECISION MADE: 09-MAR-21
Zhijiang  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
Allmed Medical Products Co., Ltd. 510(k) NO: K202411(Traditional)
ATTN: Vince  Tian                 PHONE NO : 86 717 4211111 
No. 99, Jin Shan Road, Majiadian TSE DECISION MADE: 10-MAR-21
Zhijiang  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask-Models CR02-2, CR02
Foshan Xinbao Technology Co., Ltd.510(k) NO: K202424(Traditional)
ATTN: Weishan  Peng               PHONE NO : 86 1390 2839882 
No. 20 Changjiang Road, Sanshan NeSE DECISION MADE: 31-MAR-21
Foshan  CN 528251                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ensure Single-Use Coagulation Forceps
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K202438(Traditional)
ATTN: Cecilia  Sun                PHONE NO : 86 25 58646395 
No. 10 Gaoke Thrid Road           SE DECISION MADE: 15-MAR-21
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Face Mask
Hunan EEXI Technology & Service Co510(k) NO: K202439(Traditional)
ATTN: Zhang  Xianliang            PHONE NO : 86 1587 4115252 
No. 6 North of Pingtou Road, LiuyaSE DECISION MADE: 08-MAR-21
Liuyang  CN 410300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Kit Basic, Smart Kit Pro
BSL Co., Ltd                      510(k) NO: K202443(Traditional)
ATTN: Jun  Seok Lee               PHONE NO : 82 55 3289235 
6-13, Chilsan-ro 237beon-gil      SE DECISION MADE: 11-MAR-21
Gimhae-si  KR                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
Safecare Biotech(Hangzhou)Co.,Ltd.510(k) NO: K202453(Traditional)
ATTN: Alex  Qiu                   PHONE NO : 86 571 89712897 
Building 2/203 No.18 Haishu Rd., CSE DECISION MADE: 24-MAR-21
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Y207 Electric Wheelchair
Jiangsu Intco Medical Products Co.510(k) NO: K202482(Traditional)
ATTN: Wang  Maokun                PHONE NO : 86 511 83174088 
No. 77 Yandunshan Road            SE DECISION MADE: 18-MAR-21
Dagang Zhenjiang  CN 212132       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyHomeDoc
MyHomeDoc Ltd.                    510(k) NO: K202483(Traditional)
ATTN: Orly  Maor                  PHONE NO : 972 76 8899800 
13 Zarchin St.                    SE DECISION MADE: 23-MAR-21
Ra'anana  IL 4366241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZ-IO Intraosseous Vascular Access System
Teleflex Medical                  510(k) NO: K202492(Traditional)
ATTN: Rachel  Rehl                PHONE NO : 919 4332588 
3015 Carrington Mill Blvd.        SE DECISION MADE: 22-MAR-21
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Promaxo MRI System
Promaxo, Inc.                     510(k) NO: K202518(Traditional)
ATTN: Eva  Hellman                PHONE NO : 510 7706961 
70 Washington St, Suite 407       SE DECISION MADE: 03-MAR-21
Oakland CA  94607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgivisio system
Surgivisio                        510(k) NO: K202547(Traditional)
ATTN: Vincent  Lere               PHONE NO : 33 4 58005721 
Zone Mayencin II, Parc Equation - SE DECISION MADE: 26-MAR-21
Gières  FR 38610                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Wanxinda (Guangzhou) Technology Pr510(k) NO: K202548(Traditional)
ATTN: Zeng  Xueping               PHONE NO : 0086 020 61816666 
Ling Xi Road, Accessory Section 2,SE DECISION MADE: 10-MAR-21
Guangzhou  CN 510800              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
Stryker Sustainability Solutions  510(k) NO: K202554(Traditional)
ATTN: Aphrodeja  Crutch           PHONE NO : 404 9931981 
1810 W. Drake Dr.                 SE DECISION MADE: 16-MAR-21
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Body Infrared Thermometer HT-820D
Dongguan Xintai Instrument Co., Lt510(k) NO: K202591(Traditional)
ATTN: Wei  Wang                   PHONE NO : 86 769 82612006 
South of Shuangyong Road, ChengyanSE DECISION MADE: 09-MAR-21
Dongguan  CN 523710               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Face Mask
Qinghai Zhong Dao Win-win Medical 510(k) NO: K202628(Traditional)
ATTN: Zhaochu  Chen               PHONE NO : 086 133 81230018 
No.36 Jingsan Road, Biological ParSE DECISION MADE: 19-MAR-21
Xining  CN 810000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical disposable face mask non sterile
Guangdong Zhong Ling Industrial Gr510(k) NO: K202650(Traditional)
ATTN: Ann  Ho                     PHONE NO : 86 769 22175828 
Room 101, Building 1, No. 5, ShengSE DECISION MADE: 24-MAR-21
Xinhe Wanjiang, Dongguan  CN 52304510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid E80/ Vivid E90/ Vivid E95
GE Medical Systems Ultrasound and 510(k) NO: K202658(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
9900 W. Innovation Drive          SE DECISION MADE: 05-MAR-21
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMNI Surgical System
Sight Sciences, Inc.              510(k) NO: K202678(Traditional)
ATTN: Edward J. Sinclair          PHONE NO : 650 2189149 
440 Campbell Ave, Suite 100       SE DECISION MADE: 01-MAR-21
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoWave Pain Relief and Recovery System, Model# T16-2020
Eva Medtec, Inc                   510(k) NO: K202693(Traditional)
ATTN: Irene  Waldridge            PHONE NO : 612 2513949 
6300 W. Old Shakopee Road, Suite 1SE DECISION MADE: 05-MAR-21
Bloomington MN  55438             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Masks
Intco Medical(HK) Co., Ltd.       510(k) NO: K202708(Third Party - Traditional)
ATTN: Max  Li                     PHONE NO : 86 511 83174088 
Flat/RM 19c, Lockhart Centre 301-3SE DECISION MADE: 30-MAR-21
Hong Kong  CN 999077              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Disposable Medical Face Mask
Wanxinda (Guangzhou) Technology Pr510(k) NO: K202710(Traditional)
ATTN: Zeng  Xueping               PHONE NO : 0086 020 61816666 
Ling Xi Road, Accessory Section 2,SE DECISION MADE: 09-MAR-21
Guangzhou  CN 510800              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETD4000
TheraSigma, LLC                   510(k) NO: K202725(Traditional)
ATTN: Jim  Klett                  PHONE NO : 949 6899892 
4060 South Grant St. Suite 102    SE DECISION MADE: 26-MAR-21
Washougal WA  98671               510(k) STATEMENT
                                                    

DEVICE: Med-Link Temp-pulse Oximeter
Shenzhen Med-link Electronics Tech510(k) NO: K202743(Traditional)
ATTN: Jialing  Zhang              PHONE NO : 0086 755 61568825 884
4th snf 5th Floor, Building Two, HSE DECISION MADE: 01-MAR-21
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TandemHeart Pump and Escort Controller
CardiacAssist, Inc.               510(k) NO: K202751(Traditional)
ATTN: Megan  Walsh                PHONE NO : 412 2307324 
620 Alpha Drive, Suite 2          SE DECISION MADE: 26-MAR-21
Pittsburgh PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iHealth Wireless No-Touch Forehead Thermometer
Andon Health Co., Ltd.            510(k) NO: K202753(Traditional)
ATTN: Liu  Yi                     PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 08-MAR-21
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: s-Clean SQ-SL Implant System Mini
Dentis Co., Ltd.                  510(k) NO: K202773(Traditional)
ATTN: Gyu Ri Kim                  PHONE NO : 82 53 5893541 
99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 18-MAR-21
Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip pulse oximeter
Shenzhen LEPU Intelligent Medical 510(k) NO: K202776(Traditional)
ATTN: Aaron  Lin                  PHONE NO : 86 755 86952278 
North side of floor 3, BLD 9 BaiWaSE DECISION MADE: 01-MAR-21
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROPHECY Preoperative Navigation Alignment System
Wright Medical Technology, Inc.   510(k) NO: K202815(Traditional)
ATTN: Paxia  Her                  PHONE NO : 952 6837443 
10801 Nesbitt Ave S               SE DECISION MADE: 10-MAR-21
Bloomington MN  55437             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRS Procedure Face Mask
Blackbriar Regulatory Services, LL510(k) NO: K202824(Abbreviated)
ATTN: Vincent  Angelico           PHONE NO : 954 6040972 
820 Southlake Boulevard           SE DECISION MADE: 25-MAR-21
Richmond VA  23236                510(k) STATEMENT
                                                    

DEVICE: Andorate Universal Endoscope Tip Guard
GA Health Company Limited         510(k) NO: K202838(Traditional)
ATTN: Cindy  Ye                   PHONE NO : 852 28 339010 
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 05-MAR-21
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EOGas 4 Endo-SteriTest RRBI
Andersen Sterilizers, Inc.        510(k) NO: K202879(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 03-MAR-21
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Able Medical Devices Valkyrie Thoracic Fixation System
JM Longyear Manufacturing, LLC D.B510(k) NO: K202889(Traditional)
ATTN: Wade  DePas                 PHONE NO : 906 3723213 
512 4th Street                    SE DECISION MADE: 02-MAR-21
Gwinn MI  49841                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blood Pressure Monitor
Guangdong Transtek Medical Electro510(k) NO: K202891(Traditional)
ATTN: Endless  Chan               PHONE NO : 86 188 14069928 
Zone B, No.105, Dongli Road, TorchSE DECISION MADE: 09-MAR-21
Zhongshan  CN 528437              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Face Mask
Jiangsu Excellence Medical Supplie510(k) NO: K202905(Traditional)
ATTN: Jing  Zhu                   PHONE NO : 86 519 83635058 
No.65 Huiling West Road, Zouqu TowSE DECISION MADE: 26-MAR-21
Changzhou  CN 203144              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroCap (Model DEC22)
Memory MD Inc                     510(k) NO: K202913(Traditional)
ATTN: Boris  Goldstein            PHONE NO : 1 215 3416373 
125 Wilbur Place, Suite 170       SE DECISION MADE: 05-MAR-21
Bohemia NY  111716                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LigaSure Exact Dissector, Nano-coated
Covidien llc                      510(k) NO: K202917(Traditional)
ATTN: Nancy  Sauer                PHONE NO : 720 3615290 
5920 Longbow Drive                SE DECISION MADE: 23-MAR-21
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
Ceragem Co, Ltd.                  510(k) NO: K202937(Traditional)
ATTN: Hyeonggeun  Hwang           PHONE NO : 
10, Jeongja 1-gil, Seonggeo-eup, SSE DECISION MADE: 18-MAR-21
Cheonan-si  KR 31041              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEBULAE SRS Laparoscopic Surgical Smoke Removal System
Northgate Technologies Inc.       510(k) NO: K202944(Traditional)
ATTN: Todd  Gatto                 PHONE NO : 224 8562250 
1591 Scottsdale Court             SE DECISION MADE: 25-MAR-21
Elgin IL  60123                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AquaBeam Robotic System
PROCEPT BioRobotics Corporation   510(k) NO: K202961(Traditional)
ATTN: Sara  Muddell               PHONE NO : 650 2327217 
900 Island Drive, Suite 101       SE DECISION MADE: 11-MAR-21
Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightWalker Laser System Family
Fotona d.o.o.                     510(k) NO: K202985(Traditional)
ATTN: Pucer  Anja                 PHONE NO : 386 1 5009274 
Stegne 7                          SE DECISION MADE: 19-MAR-21
Ljubljana  SI SI-1000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Toro-L Interbody Fusion System
Integrity Implants Inc            510(k) NO: K203038(Traditional)
ATTN: Lauren  Kamer               PHONE NO : 561 5293861 
354 Hiatt Drive                   SE DECISION MADE: 26-MAR-21
Palm Beach Gardens FL  33418      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Movement and Compressions System (the MAC System)
Recovery Force, LLC               510(k) NO: K203052(Traditional)
ATTN: Jeff  Schwegman             PHONE NO : 317 6054696 
10022 Lantern Rd., Suite 100      SE DECISION MADE: 21-MAR-21
Fishers IN  46037                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexSys
GME German Medical Engineering Gmb510(k) NO: K203054(Traditional)
ATTN: Stefan  Schulze             PHONE NO : 49 9131 93415910 
Dreikoenigstrasse 6-8             SE DECISION MADE: 05-MAR-21
Erlangen  DE 91054                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
Johnson & Johnson Surgical Vision,510(k) NO: K203060(Traditional)
ATTN: Amanda  Houston             PHONE NO : 512 7898317 
1700 East St. Andrew Place        SE DECISION MADE: 12-MAR-21
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ICU Health Surgical Mask
Plastikon Industries              510(k) NO: K203064(Abbreviated)
ATTN: Paul  Gutwald               PHONE NO : 510 4001010 
688 Sandoval Way                  SE DECISION MADE: 23-MAR-21
Hayward CA  94545                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumbar Spine Truss System Plating Solution (LSTS-PS)
4Web, Inc.                        510(k) NO: K203065(Traditional)
ATTN: Jessee  Hunt                PHONE NO : 800 2857090 
2801 Network Blvd., Suite 620     SE DECISION MADE: 10-MAR-21
Frisco TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magic 360 Power Wheelchair
Magic Mobility                    510(k) NO: K203083(Traditional)
ATTN: Alex  Suen                  PHONE NO : 61 3 87915600 
3 International Court             SE DECISION MADE: 17-MAR-21
Scoreby  AU 3179                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-PLO2R
Belluscura LLC                    510(k) NO: K203086(Traditional)
ATTN: Sarah  Clark                PHONE NO : 214 3968313 
5504 Democracy Dr, Suite 200      SE DECISION MADE: 02-MAR-21
Plano TX  75024                   510(k) STATEMENT
                                                    

DEVICE: Secure Wear USA Surgical Face Mask
Secured Ortho Manufacturing of Ame510(k) NO: K203101(Abbreviated)
ATTN: Vincent  Benenati           PHONE NO : 516 3433372 
28 West Jefryn Boulevard Suite C  SE DECISION MADE: 31-MAR-21
Deer Park NY  11729               510(k) STATEMENT
                                                    

DEVICE: SensorX
Durr Dental SE                    510(k) NO: K203116(Traditional)
ATTN: Oliver  Lange               PHONE NO : 490 7142 705190 
Hopfigheimer Str. 17              SE DECISION MADE: 19-MAR-21
Bietigheim-Bissingen  DE D-74321  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
ENvizion Medical Ltd.             510(k) NO: K203133(Traditional)
ATTN: Doron  Besser               PHONE NO : 972 72 2288240 
7 Haarad St.                      SE DECISION MADE: 24-MAR-21
Tel Aviv  IL 6971060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Akesis Galaxy RTi
Akesis Inc                        510(k) NO: K203146(Traditional)
ATTN: Christopher  Brown          PHONE NO : 925 4081381 
5129 Commercial Circle            SE DECISION MADE: 05-MAR-21
Concord CA  94520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DYNATAPE Suture
Medos International SARL          510(k) NO: K203186(Traditional)
ATTN: Tatyana  Korsunsky          PHONE NO : 508 8283122 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 18-MAR-21
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADD
H&abyz Co., Ltd.                  510(k) NO: K203188(Traditional)
ATTN: Namkyu  Hur                 PHONE NO : 82 070 46589300 
1F, 2-Dong, 41-16 Cheoinseong-Ro, SE DECISION MADE: 12-MAR-21
Yongin-Si  KR 17118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Intraosseous Infusion System
Bard Access Systems, Inc(BAS)[Whol510(k) NO: K203193(Traditional)
ATTN: Connor  Dahl                PHONE NO : 801 5225834 
605 North 5600 West               SE DECISION MADE: 04-MAR-21
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated Spine Instruments
Stryker Spine                     510(k) NO: K203205(Traditional)
ATTN: Megan  Callanan             PHONE NO : 551 2422429 
600 Hope Parkway SE               SE DECISION MADE: 23-MAR-21
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
Canon Medical Systems Corporation 510(k) NO: K203225(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 24-MAR-21
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VBrain
Vysioneer Inc.                    510(k) NO: K203235(Traditional)
ATTN: Jeni-Tang  Lu               PHONE NO : 609 8658659 
33 Rogers. St., # 308             SE DECISION MADE: 19-MAR-21
Cambridge MA  02142               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TaiChiC
Our United Corporation            510(k) NO: K203250(Traditional)
ATTN: Qi  Liu                     PHONE NO : 86 15 389012257 
Room 10301, 3rd Floor, Unit 1, BloSE DECISION MADE: 12-MAR-21
Xi'an  CN 710018                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-unit Abutments for CONELOG
BioHorizons Implant Systems, Inc. 510(k) NO: K203252(Traditional)
ATTN: Bill  Hornbuckle            PHONE NO : 205 9677887 
2300 Riverchase Center            SE DECISION MADE: 16-MAR-21
Birmingham AL  35244              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucent 3D Spinal System
Spinal Elements, Inc.             510(k) NO: K203254(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071816 
3115 Melrose Dr., Suite 200       SE DECISION MADE: 26-MAR-21
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Imbio RV/LV Software
Imbio, LLC                        510(k) NO: K203256(Traditional)
ATTN: William  McLain             PHONE NO : 717 6569656 
1015 Glenwood Avenue, Floor 4     SE DECISION MADE: 09-MAR-21
Minneapolis MN  55405             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Lung CAD
Siemens Healthcare GmbH           510(k) NO: K203258(Traditional)
ATTN: Abhineet  Johri             PHONE NO : 49 9191 184429 
Siemensstr. 1                     SE DECISION MADE: 31-MAR-21
Forchheim  DE 91301               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FairFix Adjustable Button System
Medacta International SA          510(k) NO: K203259(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 26-MAR-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Inquiry Steerable Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K203261(Special)
ATTN: Rick  Ferreira              PHONE NO : 877 4003740 
1435 North Hayden Road Suite 100  SE DECISION MADE: 05-MAR-21
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
Echosens                          510(k) NO: K203273(Traditional)
ATTN: Karine  Bonenfant           PHONE NO : 33 144 827856 
6 rue Ferrus                      SE DECISION MADE: 25-MAR-21
Paris  FR 75014                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Recon Support Catheter
C.R. Bard, Inc.                   510(k) NO: K203275(Third Party - Traditional)
ATTN: Andrew  Quach               PHONE NO : 480 5978252 
1625 West 3rd St                  SE DECISION MADE: 01-MAR-21
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
Gold Standard Diagnostics         510(k) NO: K203289(Traditional)
ATTN: Napoleon  Monce             PHONE NO : 530 7598000 
2851 Spafford St.                 SE DECISION MADE: 22-MAR-21
Davis CA  95618                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Gold Standard Diagnostics         510(k) NO: K203292(Traditional)
ATTN: Napoleon  Monce             PHONE NO : 530 7598000 
2851 Spafford St.                 SE DECISION MADE: 22-MAR-21
Davis CA  95618                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Gold Standard Diagnostics         510(k) NO: K203295(Traditional)
ATTN: Napoleon  Monce             PHONE NO : 530 7598000 
2851 Spafford St.                 SE DECISION MADE: 22-MAR-21
Davis CA  95618                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Gold Standard Diagnostics         510(k) NO: K203296(Traditional)
ATTN: Napoleon  Monce             PHONE NO : 530 7598000 
2851 Spafford St.                 SE DECISION MADE: 22-MAR-21
Davis CA  95618                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K203323(Traditional)
ATTN: Janine F. Reyes             PHONE NO : 714 6697853 
1385 Shimoshigami                 SE DECISION MADE: 04-MAR-21
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONSTRUX Mini Ti Spacer System
Orthofix Inc.                     510(k) NO: K203342(Traditional)
ATTN: Natalia  Volosen            PHONE NO : 214 9372145 
3451 Plano Parkway                SE DECISION MADE: 18-MAR-21
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OEC 3D
GE OEC Medical Systems, Inc.      510(k) NO: K203346(Traditional)
ATTN: Kenny M. Bello              PHONE NO : 801 2013986 
384 N Wright Brothers Drive       SE DECISION MADE: 05-MAR-21
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Perfit ZR HT Dental Zirconia blank
Vatech acucera, Inc.              510(k) NO: K203351(Traditional)
ATTN: Kyung Wook Kwon             PHONE NO : 82 31 80051851 
2544, Nambuk-daero, Idong-eup, CheSE DECISION MADE: 08-MAR-21
Yongin-si  KR                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solitaire X Revascularization Device
Micro Therapeutics, Inc d/b/a ev3 510(k) NO: K203358(Traditional)
ATTN: Kevin  Kong                 PHONE NO : 408 4620073 
9775 Toledo Way                   SE DECISION MADE: 01-MAR-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProLift Wedge Expandable Spacer System
Life Spine, Inc.                  510(k) NO: K203361(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S. Quality Drive            SE DECISION MADE: 17-MAR-21
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulsehaler
Respinova Ltd.                    510(k) NO: K203378(Traditional)
ATTN: Cliff  Ansel                PHONE NO : 972 58 6878812 
Hachoshlim 8                      SE DECISION MADE: 31-MAR-21
Herzliya  IL 4672408              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System-Easy Pack
JJGC Industria e Comercio de Mater510(k) NO: K203382(Traditional)
ATTN: Mariana Soares Hartmann     PHONE NO : 55 41 21694000 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 15-MAR-21
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlignRT Plus
Vision RT Ltd                     510(k) NO: K203387(Traditional)
ATTN: Jade  Dunphy                PHONE NO : 44 208 3464300 
Dove House, Arcadia Avenue        SE DECISION MADE: 04-MAR-21
London  GB N3 2JU                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K203391(Traditional)
ATTN: Ma  Chao                    PHONE NO : 86 755 81886573 
Keji 12th Road South, Hi-Tech InduSE DECISION MADE: 23-MAR-21
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PleuraFlow System with FlowGlide
ClearFlow, Inc,                   510(k) NO: K203394(Special)
ATTN: Serrah  Namini              PHONE NO : 714 9165014 
140 Technology Drive Suite 100    SE DECISION MADE: 02-MAR-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DVT-4000S
Daesung Maref CO., LTD.           510(k) NO: K203417(Traditional)
ATTN: Su  Hyeon So                PHONE NO : 82 31 4597211 
298-24, Gongdan-Ro                SE DECISION MADE: 28-MAR-21
Gunpo-Si  KR 15809                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
BDC Dental Corporation Ltd.       510(k) NO: K203425(Third Party - Traditional)
ATTN: Lifang  Zhang               PHONE NO : 86 20 32052929 
Part 3, No.1 Guanchong Section, ShSE DECISION MADE: 05-MAR-21
Guangzhou  CN 511450              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Ziehm Vision RFD
Ziehm Imaging GmbH                510(k) NO: K203428(Special)
ATTN: Stefan  Fiedler             PHONE NO : 49 0911 2172219 
Lina-Ammon-Strasse 10             SE DECISION MADE: 17-MAR-21
Nuremberg  DE 90471               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
Siemens Medical Solutions USA, Inc510(k) NO: K203443(Traditional)
ATTN: Andrew  Turner              PHONE NO : 610 8505627 
40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 31-MAR-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEE HA Cage
NGMedical GmbH                    510(k) NO: K203444(Traditional)
ATTN: Stella  Hahn                PHONE NO : 49 6873 99997100 
Talsperrenblick 5                 SE DECISION MADE: 18-MAR-21
Nonnweiler  DE 66620              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DORO QR3 Headrest System (Aluminum)
pro med instruments GmbH          510(k) NO: K203505(Traditional)
ATTN: Muhammad  Zubair            PHONE NO : 49 0761 38422210 
Boetziger Str. 38                 SE DECISION MADE: 29-MAR-21
Freiburg  DE 79111                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quicktome
Omniscient Neurotechnology Pty Ltd510(k) NO: K203518(Traditional)
ATTN: Arie  Henkin                PHONE NO : 1 416 5009985 
Level 10, 580 George Street       SE DECISION MADE: 09-MAR-21
Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FineCross M3
Ashitaka Factory of Terumo Corpora510(k) NO: K203521(Traditional)
ATTN: Vaibhav  Sivaramakrishan    PHONE NO : 609 6133958 
150 Maimaigi-cho                  SE DECISION MADE: 03-MAR-21
Fujinomiya  JP 418-0015           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nalu Neurostimulation System
Nalu Medical, Inc.                510(k) NO: K203547(Traditional)
ATTN: Pauline  Lieu               PHONE NO : 858 4426370 
2320 Faraday Ave. Suite 100       SE DECISION MADE: 25-MAR-21
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERIZONE VP4 Test Pack
TSO3 Inc., Now a part of Stryker  510(k) NO: K203560(Traditional)
ATTN: Karan  Modi                 PHONE NO : 269 8880305 
2505, avenue Dalton               SE DECISION MADE: 24-MAR-21
Québec  CA G1P 3S5                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
Hivox Biotek Inc.                 510(k) NO: K203574(Traditional)
ATTN: Ruby  Lu                    PHONE NO : 886 2 25112668 510
SF, No. 123, Xingde Road, SanchongSE DECISION MADE: 10-MAR-21
New Taipei City  TW 241           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORZA Ti Spacer System
Orthofix Inc.                     510(k) NO: K203576(Traditional)
ATTN: Natalia  Volosen            PHONE NO : 214 9372145 
3451 Plano Parkway                SE DECISION MADE: 03-MAR-21
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tigertriever and Tigertriever 17 Revascularization Devce
Rapid Medical Ltd.                510(k) NO: K203592(Traditional)
ATTN: Orit  Yaniv                 PHONE NO : 972 72 2503331 
Carmel Building, POB 337          SE DECISION MADE: 23-MAR-21
Yokneam  IL 2069205               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Examination Gloves
Guang Dong Kingfa SCI. & TECH.CO.,510(k) NO: K203593(Traditional)
ATTN: Xiaoge  Yu                  PHONE NO : 86 135 70952157 
No. 28 Delong Ave., Shijiao Town, SE DECISION MADE: 19-MAR-21
Qingyuan  CN 511545               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaWrap
Alafair Biosciences Inc           510(k) NO: K203600(Traditional)
ATTN: Angela  Mallery             PHONE NO : 800 2065586 
6101 W Courtyard Drive ste 2-225  SE DECISION MADE: 09-MAR-21
Austin TX  78730                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
Meris Investment Group            510(k) NO: K203606(Traditional)
ATTN: Gary  Maas                  PHONE NO : 651 4025577 
16688 7th Street South            SE DECISION MADE: 10-MAR-21
Lakeland MN  55043                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capture-CMV
Immucor, Inc.                     510(k) NO: K203612(Traditional)
ATTN: Steven  Appel               PHONE NO : 770 4412051 
3130 Gateway Drive                SE DECISION MADE: 22-MAR-21
Norcross GA  30071                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monarch Bronchoscope
Auris Health Inc., a Johnson and J510(k) NO: K203614(Traditional)
ATTN: Somi  Ekwealor              PHONE NO : 408 3205385 
150 Shoreline Drive               SE DECISION MADE: 11-MAR-21
Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MaxFOV 2
GE Medical Systems, LLC.          510(k) NO: K203617(Traditional)
ATTN: Amy  Yang                   PHONE NO : 414 5143904 
3000 N Grandview Blvd             SE DECISION MADE: 02-MAR-21
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent EasyGuide Kit Cases
JJGC Industria e Comercio de Mater510(k) NO: K203618(Traditional)
ATTN: Camila da Silva Esteves     PHONE NO : 55 41 21694000 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 09-MAR-21
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aneroid Sphygmomanometer
Wuxi Exanovo Medical Instrument Co510(k) NO: K203620(Traditional)
ATTN: Xiao  Huang                 PHONE NO : 86 0510 83791431 
No. 42, Xixin Road, Zhangjing, XibSE DECISION MADE: 23-MAR-21
Wuxi  CN 214194                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-Denture Pro
EnvisionTEC GmbH                  510(k) NO: K203641(Traditional)
ATTN: Ruediger  van Bernum        PHONE NO : 49 2043 987545 
Brusseler Straße 51               SE DECISION MADE: 30-MAR-21
Gladbeck  DE D-45968              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRI PPG Patient Cable
Ivy Biomedical Systems, Inc.      510(k) NO: K203653(Traditional)
ATTN: Alejandra  Aceves           PHONE NO : 203 4814183 
11 Business Park Drive            SE DECISION MADE: 02-MAR-21
Branford CT  06405                510(k) STATEMENT
                                                    

DEVICE: Vinyl Examination Gloves(Yellow)
Lutai Medical Technology Co.,LTD. 510(k) NO: K203666(Traditional)
ATTN: Xiaomeng  Xiaomeng Li       PHONE NO : 86 186 53343268 
Tiandingfeng Road                 SE DECISION MADE: 12-MAR-21
Dezhou  CN 251500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatic Registration
Brainlab AG                       510(k) NO: K203679(Special)
ATTN: Chiara  Cunico              PHONE NO : 49 899 915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 18-MAR-21
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neurosign V4 Intraoperative Nerve Monitor
Magstim Company Ltd.              510(k) NO: K203684(Traditional)
ATTN: Rosie  Hunt                 PHONE NO : 440 1994 240798 
Spring Gardens                    SE DECISION MADE: 17-MAR-21
Whitland  GB SA34 0HR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Face Mask
Xiantao Zhongyi Safety & Protectio510(k) NO: K203685(Traditional)
ATTN: Yang  Xi                    PHONE NO : 86 136 51733375 
No.101, Xianyuan Road             SE DECISION MADE: 26-MAR-21
Xiantao  CN 433000                510(k) STATEMENT
                                                    

DEVICE: BC Reflex Uni Knee System
Bodycad Laboratories, Inc.        510(k) NO: K203697(Special)
ATTN: Nadine  Adia                PHONE NO : 418 5271388 
                                  SE DECISION MADE: 12-MAR-21
Quebec City  CA G1N 4R7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I-Q View
First Source, Inc.                510(k) NO: K203703(Traditional)
ATTN: Susan  Ryan-Kron            PHONE NO : 585 2721690 
3495 Winton Place, Bldg E Ste 1   SE DECISION MADE: 24-MAR-21
Rochester NY  14623               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
ShenZhen ZhengKang Technology Co.,510(k) NO: K203707(Traditional)
ATTN: Huayong  Yang               PHONE NO : 86 0755 83260864 
2&3/F, Building A, No.3 FuXing Yi SE DECISION MADE: 12-MAR-21
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spark Clear Aligner System
Ormco Corporation                 510(k) NO: K203737(Traditional)
ATTN: Frank  Ray                  PHONE NO : 704 5877227 
200 S Kraemer Blvd                SE DECISION MADE: 22-MAR-21
Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shoulder System - TiNbN Coating
Medacta International SA          510(k) NO: K203755(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 02-MAR-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Imperative Care Inc.              510(k) NO: K203764(Traditional)
ATTN: Kristin  Ellis              PHONE NO : 408 8570934 
1359 Dell Avenue                  SE DECISION MADE: 03-MAR-21
Campbell CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIC disposable medical mask
The Aleen International Corporatio510(k) NO: K203775(Traditional)
ATTN: Can  Huang                  PHONE NO : 086 62 3496999 
Jiutian Green Science and TechnoloSE DECISION MADE: 12-MAR-21
Heyuan  CN 517000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Masks, Model SNN200640 & MN112
SQ Medical Supplies Inc.          510(k) NO: K203776(Traditional)
ATTN: Jonathan  Lim               PHONE NO : 888 9128168 
8889 West Olympic Blvd. Suite 1000SE DECISION MADE: 25-MAR-21
Beverly Hills CA  90211           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Harvester SI: Sacroiliac Fixation System
Spinus International, Inc.        510(k) NO: K203780(Traditional)
ATTN: Ron  Oman                   PHONE NO : 254 7604173 
7200 North Interstate Highway 35, SE DECISION MADE: 23-MAR-21
Georgetown TX  79626              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DermaV Laser System
Lutronic Corporation              510(k) NO: K203788(Traditional)
ATTN: Jhung Won Vojir             PHONE NO : 888 5887644 
Lutronic Center, 219, Sowon-Ro    SE DECISION MADE: 26-MAR-21
Deogyang-Gu, Goyang-si  KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ponto Bone Anchored Hearing System, MONO Surgery Kit
Oticon Medical AB                 510(k) NO: K203807(Special)
ATTN: Carolina Anker Wessling     PHONE NO : 46 76 1686332 
Datavagen 37B                     SE DECISION MADE: 03-MAR-21
Askim  SE SE-436 32               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProFound AI Software V3.0
iCAD Inc.                         510(k) NO: K203822(Special)
ATTN: Heather  Reed               PHONE NO : 603 3091945 
98 Spit Brook Rd. Suite 100       SE DECISION MADE: 12-MAR-21
Nashua NH  03062                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LaserCap Family of Lasers 300, 224, 120 & 80
Transdermal Cap, Inc.             510(k) NO: K203826(Traditional)
ATTN: Michael  Rabin              PHONE NO : 440 2411846 
26 Alpha Park                     SE DECISION MADE: 29-MAR-21
Highland Heights OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REMI
Epitel, Inc.                      510(k) NO: K203827(Traditional)
ATTN: Mark  Lehmkuhle             PHONE NO : 801 4976297 
124 S. 400 E.                     SE DECISION MADE: 29-MAR-21
Salt Lake City UT  84111          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Patella SuturePlates
Arthrex Inc.                      510(k) NO: K203834(Traditional)
ATTN: Rebecca R. Homan            PHONE NO : 239 6435553 73429
1370 Creekside Boulevard          SE DECISION MADE: 25-MAR-21
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BOMEDENT Apex locator, WISMY Apex locator
ChangZhou BoMedent Medical Technol510(k) NO: K203836(Traditional)
ATTN: Zhang  Lili                 PHONE NO : 86 0519 88991980 
No.9 Changyang Road, West Taihu ScSE DECISION MADE: 30-MAR-21
Changzhou  CN 213100              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MI DeTACH
Biorep Technologies, Inc          510(k) NO: K210006(Traditional)
ATTN: Victoria  Enjamio           PHONE NO : 305 3304449 403
15804 NW 57th Avenue              SE DECISION MADE: 04-MAR-21
Miami Lakes FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMK Revision & Hinge Extension - TiNbN Coating
Medacta International SA          510(k) NO: K210010(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 02-MAR-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
Unimed Medical Supplies, Inc.     510(k) NO: K210019(Traditional)
ATTN: Linbin  Ye                  PHONE NO : 86 755 26695137 
 Bld#8, Nangang 3rd Industrial ParSE DECISION MADE: 04-MAR-21
Shenzhen  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HySil Plus Impression Materials
Osstem Implant Co., Ltd.          510(k) NO: K210041(Traditional)
ATTN: Jinwoo  Bae                 PHONE NO : 82 51 8502500 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 18-MAR-21
Busan  KR 48002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOQTEQ Distal Lateral Femur Plate 4.5 System
AAP Implantate AG                 510(k) NO: K210043(Traditional)
ATTN: Agnieszka  Mierzejewska     PHONE NO : 11 49 3075019129 
Lorenzweg 5                       SE DECISION MADE: 03-MAR-21
Berlin  DE 12099                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Nitrile Exam Glove, Powder Free
Real Star Medical Technology Co., 510(k) NO: K210057(Traditional)
ATTN: Nie  Jian                   PHONE NO : 86 139 53305660 
Youdi Industry Park in Dongying DiSE DECISION MADE: 31-MAR-21
Dongying  CN 257100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Nitrile Exam Glove, Powder Free
Great Harvest Trading Co., Ltd.   510(k) NO: K210058(Traditional)
ATTN: Chongfeng  Zhao             PHONE NO : 86 13 508943885 
Xinghe Road                       SE DECISION MADE: 30-MAR-21
Dongying  CN 257100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoLink Mfx Implant System
In2Bones USA, LLC                 510(k) NO: K210060(Traditional)
ATTN: Christine  Scifert          PHONE NO : 901 8318053 
6000 Poplar Ave, Suite 115        SE DECISION MADE: 12-MAR-21
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIS System (Version 5.1.0)
Surgical Information Sciences, Inc510(k) NO: K210071(Traditional)
ATTN: Ann  Quinlan-Smith          PHONE NO : 612 3250187 
10405 6th Avenue N, Suite 110     SE DECISION MADE: 31-MAR-21
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker ProCinch Adjustable Loop Device
Stryker Endoscopy                 510(k) NO: K210078(Traditional)
ATTN: Victoria  Milich            PHONE NO : 508 6426132 
5900 Optical Court                SE DECISION MADE: 11-MAR-21
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guidion
IMDS Operations B.V.              510(k) NO: K210110(Traditional)
ATTN: Edwin  Schulting            PHONE NO : 31 508 200230 
Ceintuurbaan Noord 150            SE DECISION MADE: 31-MAR-21
Roden  NL 9301 NZ                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BonOs HV, BonOs MV, BonOs LV
Osartis GmbH                      510(k) NO: K210120(Traditional)
ATTN: Volker  Stirnal             PHONE NO : 49 6071 9290 
Auf der Beune 101                 SE DECISION MADE: 19-MAR-21
Munster  DE 64839                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
OSARTIS GmbH                      510(k) NO: K210125(Traditional)
ATTN: Volker  Stirnal             PHONE NO : 49 6071 9290 
Auf der Beune 101                 SE DECISION MADE: 19-MAR-21
Munster  DE 64839                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fiber Dust
Quanta System Spa                 510(k) NO: K210142(Traditional)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 376797 
via Acquedotto 109                SE DECISION MADE: 11-MAR-21
Samarate (Va)  IT 21017           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Elan 1.5T, MRT-2020, V6.0
Canon Medical Systems Corporation 510(k) NO: K210164(Traditional)
ATTN: Janine F. Reyes             PHONE NO : 714 6697853 
1385 Shimoshigami                 SE DECISION MADE: 10-MAR-21
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StarGuide
GE Healthcare                     510(k) NO: K210173(Traditional)
ATTN: George  Mashour             PHONE NO : 972 4 8563666 639
4 Hayozma Street                  SE DECISION MADE: 29-MAR-21
Tirat Hacarmel  IL 30200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nordiwell Surgical Face Mask
Changzhou Combat Protective Equipm510(k) NO: K210181(Special)
ATTN: Yanmei  Song                PHONE NO : 86 519 85190068 
QingSiTang village, Henglin Town, SE DECISION MADE: 09-MAR-21
Changzhou  CN 213101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DB-Composite
Dimensional Bioceramics, LLC      510(k) NO: K210193(Traditional)
ATTN: Duran N. Yetkinliner        PHONE NO : 408 7576603 
2161 Delaware Ave, Suite A        SE DECISION MADE: 15-MAR-21
Santa Cruz CA  95060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Synthes (USA) products, LLC       510(k) NO: K210205(Traditional)
ATTN: Satapa  Dhamankar           PHONE NO : 1 610 7196574 
1301 Goshen Parkway               SE DECISION MADE: 26-MAR-21
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Humeral Eccentric Reverse Metaphysis
Medacta International SA          510(k) NO: K210207(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 26-MAR-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viz ICH
Viz.ai, Inc.                      510(k) NO: K210209(Traditional)
ATTN: Gregory  Ramina             PHONE NO : 239 8983105 
350 Rhode Island St, Suite 240    SE DECISION MADE: 23-MAR-21
San Francisco CA  94103           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Feng Chun Yuan Medical Equipment (510(k) NO: K210225(Third Party - Traditional)
ATTN: Qiyuan  Ning                PHONE NO : 86 755 27900876 
Room 1304, Technology Innovation PSE DECISION MADE: 04-MAR-21
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PicoSure Workstation
Cynosure LLC                      510(k) NO: K210226(Traditional)
ATTN: Michael  King               PHONE NO : 781 9932454 
5 Carlisle Road                   SE DECISION MADE: 30-MAR-21
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Vision Quadra PET/CT System
Siemens Medical Solutions USA, Inc510(k) NO: K210262(Special)
ATTN: Alaine  Medio               PHONE NO : 865 2060337 
810 Innovation Drive              SE DECISION MADE: 03-MAR-21
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OverStitch Sx Endoscopic Suturing System
Apollo Endosurgery Inc.           510(k) NO: K210266(Special)
ATTN: David  Hooper               PHONE NO : 512 8523757 
1120 South Capital of Texas Hwy., SE DECISION MADE: 02-MAR-21
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Modulus ALIF System
NuVasive, Incorporated            510(k) NO: K210271(Special)
ATTN: Jessica  LeBlanc            PHONE NO : 951 816 0973
7475 Lusk Blvd.                   SE DECISION MADE: 01-MAR-21
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Rapid Readout Biological Indicator, 1295
3M Company                        510(k) NO: K210277(Special)
ATTN: Mary  Fretland              PHONE NO : 651 7372296 
3M Center, Building 275-5W-06     SE DECISION MADE: 03-MAR-21
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geistlich Mucograft®, Geistlich Mucograft® Seal
Geistlich Pharma AG               510(k) NO: K210280(Special)
ATTN: Marco  Steiner              PHONE NO : 41 41 4926764 
Bahnhofstrasse 40                 SE DECISION MADE: 03-MAR-21
Wolhusen  CH CH-6110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WIRION Embolic Protection System
Cardiovascular Systems Inc.       510(k) NO: K210282(Special)
ATTN: Erika  Huffman              PHONE NO : 877 2740360 
1225 Old Hwy 8 NW                 SE DECISION MADE: 03-MAR-21
St. Paul MN  55112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Adaptable Ortho Innovations Intramedullary Nail System
Adaptable Ortho Innovations, LLC  510(k) NO: K210285(Traditional)
ATTN: Steve  Palin                PHONE NO : 315 4392343 
65 Main Street                    SE DECISION MADE: 18-MAR-21
Potsdam NY  13676                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cure 2.0 Anterior Cervical Plate (ACP) System
Meditech Spine, LLC               510(k) NO: K210286(Special)
ATTN: Bruce  Dunaway              PHONE NO : 678 974 5287
1447 Peachtree St NE Suite 440    SE DECISION MADE: 18-MAR-21
Atlanta GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriClip LAA Exclusion System
AtriCure, Inc.                    510(k) NO: K210293(Special)
ATTN: Mary  Galeano               PHONE NO : 513 2576279 
7555 Innovation Way               SE DECISION MADE: 03-MAR-21
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Select (VA21) Image Intensifier
Siemens Medical Solutions USA, Inc510(k) NO: K210307(Special)
ATTN: Cordell  Fields             PHONE NO : 610 3063167 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 04-MAR-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMPOWR Porous Femur with HAnano SurfaceTM
Encore Medical, L.P.              510(k) NO: K210308(Traditional)
ATTN: Christine  Chesnutt         PHONE NO : 512 8346207 
9800 Metric Blvd.                 SE DECISION MADE: 30-MAR-21
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Select (VA21) Flat Panel
Siemens Medical Solutions USA, Inc510(k) NO: K210309(Special)
ATTN: Cordell  Fields             PHONE NO : 610 3063167 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 05-MAR-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mars1717X Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd.      510(k) NO: K210314(Special)
ATTN: Meng  Li                    PHONE NO : 86 0512 53690872 
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 02-MAR-21
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mars 1417X Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd.      510(k) NO: K210316(Special)
ATTN: Meng  Li                    PHONE NO : 86 0512 53690872 
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 03-MAR-21
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
CareFusion 2200 Inc               510(k) NO: K210324(Special)
ATTN: Jane  Weber                 PHONE NO : 847 3628094 
75 North Fairway Drive            SE DECISION MADE: 04-MAR-21
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APOLLO Anterior Cervical Plate (ACP) System
Aurora Spine, Inc.                510(k) NO: K210325(Traditional)
ATTN: Laszlo  Garamszegi          PHONE NO : 760 4242004 
1930 Palomar Point Way, Suite 103 SE DECISION MADE: 23-MAR-21
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafeSept Blunt Needle
Pressure Products Medical Device M510(k) NO: K210328(Special)
ATTN: Andrew  Amour               PHONE NO : 610 5432324 
1 School Street                   SE DECISION MADE: 05-MAR-21
Morton PA  19070                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiaPaste
Diadent Group International       510(k) NO: K210333(Special)
ATTN: Kab Sun Lee                 PHONE NO : 82 43 2662315 
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 25-MAR-21
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hexanium TLIF
SpineVision SAS                   510(k) NO: K210359(Special)
ATTN: Arnaud  Brisard             PHONE NO : 33 153 332552 
10 rue de la Renaissance          SE DECISION MADE: 10-MAR-21
Batiment E  FR 92160              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apex 3D Total Ankle Replacement System
Paragon 28, Inc.                  510(k) NO: K210390(Special)
ATTN: Haylie  Hertz               PHONE NO : 888 7281888 
14445 Grasslands Dr.              SE DECISION MADE: 06-MAR-21
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WorkMate Claris System
Abbott                            510(k) NO: K210392(Special)
ATTN: Ed  Sandberg                PHONE NO : 651 2458398 
One St. Jude Medical Drive        SE DECISION MADE: 11-MAR-21
St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinity™ OCT System, PASS OCT® Spinal System
Medtronic                         510(k) NO: K210449(Special)
ATTN: Shweta  Sharma              PHONE NO : 901 3992425 
1800 Pyramid Place                SE DECISION MADE: 18-MAR-21
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BBX-PET Scanner
Prescient Imaging, LLC            510(k) NO: K210450(Third Party - Traditional)
ATTN: Farhad  Daghighian          PHONE NO : 1 310 4284101 
12569 Crenshaw Blvd               SE DECISION MADE: 17-MAR-21
Hawthorne CA  90250               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SPINEART Navigation Instrument System
Spineart                          510(k) NO: K210472(Special)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 chemin du pré Fleuri            SE DECISION MADE: 19-MAR-21
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMPACT and X-Ranger
MinXray, Inc.                     510(k) NO: K210479(Special)
ATTN: Keith  Kretchmer            PHONE NO : 847 5640323 
3611 Commercial Avenue            SE DECISION MADE: 19-MAR-21
Northbrook IL  60062              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIPLNI YK-244 Disposable Surgical Mask
Hunan Yuankang Biological Technolo510(k) NO: K210487(Third Party - Traditional)
ATTN: Kylin Rui Chen              PHONE NO : 86 135 60755999 
Heping Team, Sanlian Community, XiSE DECISION MADE: 16-MAR-21
Hengyang  CN 421000               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Betta Link Knotless Implant System
T.A.G. Medical Products Corporatio510(k) NO: K210498(Special)
ATTN: Shlomi  Dines               PHONE NO : 972 4 9858400 
Gaaton                            SE DECISION MADE: 24-MAR-21
Gaaton  IL 2513000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Cautery Tip Cleaner
Medline Industries, Inc.          510(k) NO: K210526(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
Three Lakes Drive                 SE DECISION MADE: 12-MAR-21
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Gramercy Extremity Orthopedics, LL510(k) NO: K210534(Special)
ATTN: Michael P. Simpson          PHONE NO : 855 4362278 
1239 N Glenville Dr               SE DECISION MADE: 26-MAR-21
Richardson TX  75081              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VALO Grand Corded and Accessory Lenses
Ultradent Products, Inc           510(k) NO: K210550(Third Party - Traditional)
ATTN: Adam  Black                 PHONE NO : 801 5724200 
505 West Ultradent Drive (10200 SoSE DECISION MADE: 01-MAR-21
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Persona Revision Knee System
Zimmer, Inc.                      510(k) NO: K210551(Special)
ATTN: Romil  Sheth                PHONE NO : 574 2688196 
1800 W. Center Street             SE DECISION MADE: 18-MAR-21
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7D Surgical System - Drill Guide
7D Surgical Inc.                  510(k) NO: K210555(Special)
ATTN: Daniel  Zisind              PHONE NO : 647 4840079 
60 scarsdale road, unit 118       SE DECISION MADE: 23-MAR-21
Toronto  CA M3B 2R7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LEGION Porous CR Narrow Femoral Components
Smith & Nephew, Inc.              510(k) NO: K210566(Special)
ATTN: Michelle  Huettner          PHONE NO : 765 4266070 
1450 Brooks Road                  SE DECISION MADE: 25-MAR-21
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SDC3 HD Information Management System with Wireless Device Control Capability
Stryker                           510(k) NO: K210584(Special)
ATTN: Divya  Sekar                PHONE NO : 669 2044851 
5900 Optical Ct                   SE DECISION MADE: 18-MAR-21
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Bair Hugger Temperature Management System (Model 675)
3M Company                        510(k) NO: K210603(Special)
ATTN: Brian  Kleiber              PHONE NO : 651 7370195 
3M Center, 2510 Conway Ave. Bldg. SE DECISION MADE: 30-MAR-21
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Longeviti PMMA Static Cranial Implant
Longeviti Neuro Solutions, LLC    510(k) NO: K210616(Special)
ATTN: Heather  Hourihan           PHONE NO : 410 5271803 
303 International Circle Suite 190SE DECISION MADE: 31-MAR-21
Hunt Valley MD  21030             510(k) STATEMENT
                                                    

DEVICE: Avitus(r) Bone Harvester
Avitus Orthopaedics, Inc.         510(k) NO: K210631(Special)
ATTN: Maxim  Budyansky            PHONE NO : 860 6379920 
6 Amstrong Rd, Suite 107          SE DECISION MADE: 31-MAR-21
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-ED COIL System
Kaneka Medical America LLC        510(k) NO: K210638(Special)
ATTN: Audra  Bogucki              PHONE NO : 917 6289870 
623 Fifth Avenue                  SE DECISION MADE: 26-MAR-21
New York NY  10022                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnCor Breast Biopsy Probe with Rinse Tube
SenoRx, Inc.                      510(k) NO: K210654(Special)
ATTN: Jessica  Myer               PHONE NO : 480 5978420 
1625 West 3rd Street              SE DECISION MADE: 31-MAR-21
Tempe AZ  85251                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIREBIRD SI Fusion System
Orthofix Inc.                     510(k) NO: K210667(Special)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 25-MAR-21
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIOnavi-Denture02
DIO Corporation                   510(k) NO: K210828(Third Party - Traditional)
ATTN: Ji-Ae  Park                 PHONE NO : 82 51 7457836 
66, Centumseo-ro, Haeundae-gu,    SE DECISION MADE: 23-MAR-21
Busan  KR 48058                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


         TOTAL 510(k)s THIS PERIOD   270                                     
         TOTAL WITH SUMMARIES        254                                     
         TOTAL WITH STATEMENTS        16
                                      
 
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