U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals and Clearances
  5. 510(k) Clearances
  6. August 2022 510(K) Clearances
  1. 510(k) Clearances

August 2022 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2022


DEVICE: Solidence Multipockets
Solidence Surgical Corporation    510(k) NO: K191131(Traditional)
ATTN: Morris  Azad                PHONE NO : 1 818 3616900 
1104 San Fernando Road            SE DECISION MADE: 03-AUG-22
San Fernando CA  91340            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powered Inflatable Tube Massager - SLIM UP DRAIN
Foggiare Technologies LLC         510(k) NO: K201730(Traditional)
ATTN: Thierry  Germanovitch       PHONE NO : 954 9998063 
1920 West Bay Drive, Suite 4      SE DECISION MADE: 22-AUG-22
Largo FL  33770                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
Smisson-Cartledge Biomedical LLC  510(k) NO: K202461(Traditional)
ATTN: Calder  Clay III            PHONE NO : 478 7449992 
487 Cherry Street - Third Street TSE DECISION MADE: 12-AUG-22
Macon GA  31201                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hemo-Lyte C Cartridge
Di-Chem, Inc.                     510(k) NO: K202508(Traditional)
ATTN: Keith  Buchholz             PHONE NO : 763 4228311 
12297 Ensigh Avenue North         SE DECISION MADE: 12-AUG-22
Champlin MN  55316                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
Bioland Technology Ltd.           510(k) NO: K202739(Special)
ATTN: Yiqing  Feng                PHONE NO : 86 755 36900999 
No. A6B7 (Block G), ShangRong InduSE DECISION MADE: 12-AUG-22
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
HuiZhou TianChang Industrial Co., 510(k) NO: K203078(Abbreviated)
ATTN: Johnny  Chan                PHONE NO : 86 752 3183968 
No.2 XingDe East Road, DongJiang HSE DECISION MADE: 19-AUG-22
Huizhou  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QOCA Portable ECG Monitoring Device
Quanta Computer Inc.              510(k) NO: K210179(Traditional)
ATTN: Vivian  Yang                PHONE NO : 886 3 3272345 12928
No. 188, Wenhua 2nd Road, Guishan SE DECISION MADE: 02-AUG-22
Taoyuan City  TW 33377            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: implaFit® hip stems
implantcast, GmbH                 510(k) NO: K210678(Traditional)
ATTN: Juliane  Hoppner            PHONE NO : 49 4161 7440 
Luneburger Schanze 26             SE DECISION MADE: 17-AUG-22
21614 Buxtehude  DE               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bio-MEM Ti Reinforced Membrane
B&Medi Co., Ltd.                  510(k) NO: K210797(Traditional)
ATTN: Taesu  Kwon                 PHONE NO : 82 2 62950085 
56-33, Chukhang-daero 296Beon-gil,SE DECISION MADE: 18-AUG-22
Incheon  KR 22339                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
I.T.S. GmbH                       510(k) NO: K210935(Traditional)
ATTN: Florian  Grill              PHONE NO : 0043 316 2112140 
Autal 28                          SE DECISION MADE: 31-AUG-22
Lassnitzhoehe  AT 8301            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Foundation Dermal Regeneration Scaffold (DRS) Solo
Bionova Medical Inc.              510(k) NO: K210949(Traditional)
ATTN: Alex  Greene                PHONE NO : 901 7482581 
3012 Centre Oak Way, Ste 102      SE DECISION MADE: 11-AUG-22
Germantown TN  38138              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dose IQ Safety Software
Baxter Healthcare Corporation     510(k) NO: K211124(Traditional)
ATTN: Michelle  Rixie             PHONE NO : 224 2702861 
One Baxter Parkway                SE DECISION MADE: 30-AUG-22
Deerfield IL  60015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Novum IQ Syringe Pump
Baxter Healthcare Corporation     510(k) NO: K211125(Traditional)
ATTN: Dhiraj  Bizzul              PHONE NO : 847 9096828 
One Baxter Parkway                SE DECISION MADE: 30-AUG-22
Deerfield IL  60015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WiEMSpro
Medical Cables S.L.               510(k) NO: K211298(Traditional)
ATTN: José Fuertes Peña           PHONE NO : 34 95 2218991 
Calle Ferrocarril del Puerto 18 - SE DECISION MADE: 25-AUG-22
Málaga  ES 29002                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Latex Examination Glove, Non-Sterile
WRP Asia Pacific SDN. BHD.        510(k) NO: K211601(Traditional)
ATTN: Siti Syamimie Atirah Binti MPHONE NO : 60 3 87061486 
Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 22-AUG-22
Sepang  MY 43900                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CenterMed Patient Matched Assisted Surgical Planning (ASP) System
CenterMed, Inc.                   510(k) NO: K211614(Traditional)
ATTN: Jash  Bhayani               PHONE NO : 855 8408823 
226 N Wiget Ln                    SE DECISION MADE: 04-AUG-22
Walnut Creek CA  94598            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dasky Disposable Sampling Tube (Model name: VSM02)
Ningbo Dasky Life Science Co., Ltd510(k) NO: K211675(Traditional)
ATTN: Wilson  Wong                PHONE NO : 86 135 66546046 
No. 6, Donggong 1st Road, Yinzhou SE DECISION MADE: 08-AUG-22
Ningbo  CN 315000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
The GOOD Corporation              510(k) NO: K211771(Traditional)
ATTN: Hak Rae Lee                 PHONE NO : 82 31 6849812 
47-13 Eoso 3-gil, Cheongbuk-eup   SE DECISION MADE: 24-AUG-22
Pyeongtaek-si  CN 17795           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRI Planner
Spectronic Medical AB             510(k) NO: K211841(Traditional)
ATTN: Per  Bruhn                  PHONE NO : 46 735 116042 
Karbingatan 36                    SE DECISION MADE: 25-AUG-22
Helsingborg  SE 25467             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle
Shandong Zhushi Pharmaceutical Gro510(k) NO: K212033(Traditional)
ATTN: Junhui  Zhu                 PHONE NO : 86 157 64021131 
No. 6, Shande Road, Shan County   SE DECISION MADE: 17-AUG-22
Heze  CN 274300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurGuard3 Safety Hypodermic Needle
Terumo Europe N.V.                510(k) NO: K212095(Traditional)
ATTN: L.  Decoster                PHONE NO : 32 1638 1365 
Interleuvenlaan 40                SE DECISION MADE: 22-AUG-22
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlucoSure Link Blood Glucose Monitoring System
Apex Biotechnology Corp.          510(k) NO: K212140(Traditional)
ATTN: Lisa  Liu                   PHONE NO : 886 3 5641952 
No. 7, Li-Hsin Rd. V, Hsinchu ScieSE DECISION MADE: 25-AUG-22
Hsinchu  TW 30078                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
Phadia AB                         510(k) NO: K212181(Traditional)
ATTN: Anna Torell Holm            PHONE NO : 46 18 163875 
Rapsgatan 7P                      SE DECISION MADE: 03-AUG-22
Uppsala  SE 75137                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST- Gram Positive Telavancin (<=0.015 -  >=1 µg/mL)
bioMerieux, Inc                   510(k) NO: K212243(Traditional)
ATTN: Cherece L. Jones            PHONE NO : 314 7318684 
595 Anglum Rd.                    SE DECISION MADE: 08-AUG-22
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlucoLeader Enhance 2 Blood Glucose Monitoring System
HMD BioMedical Inc.               510(k) NO: K212248(Special)
ATTN: Chin-Hsiung  Hsu            PHONE NO : 886 3 5895000 
No. 181, Minsheng Street          SE DECISION MADE: 29-AUG-22
Hsinchu County  TW 30548          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apollo Duet (Model : APD-4000)
Weero Co.                         510(k) NO: K212253(Traditional)
ATTN: Jimin  Han                  PHONE NO : 82 31 51828588 
A605 Venture Valley II, 142-10, SaSE DECISION MADE: 25-AUG-22
Suwon-si  KR 16648                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cross Protection ResQ300 Plus Surgical Face Mask
Cross Protection (M) Sdn Bhd      510(k) NO: K212273(Traditional)
ATTN: Grace  Tan                  PHONE NO : 60 3 33920000 
11, JLN Perindustrian5, JLN Meru  SE DECISION MADE: 17-AUG-22
Klang  MY 41050                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Novo
PathAI, INC.                      510(k) NO: K212361(Traditional)
ATTN: Kathy  Wack                 PHONE NO : 617 5008457 
1325 Boylston Avenue              SE DECISION MADE: 11-AUG-22
Boston MA  02215                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLT Dental Implant System
Bio Concept Co., Ltd              510(k) NO: K212364(Traditional)
ATTN: Tianshui  Li                PHONE NO : 86 519851 72266 
Unit C, No. 26, Huashan Middle RoaSE DECISION MADE: 10-AUG-22
Changzhou  CN 213022              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leaderflex Mini and Leaderflex Nano
Vygon USA                         510(k) NO: K212370(Traditional)
ATTN: Lauren  Doyle               PHONE NO : 774 3641125 
2750 Morris Rd Suite A200         SE DECISION MADE: 29-AUG-22
Lansdale PA  19446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YUWELL Finger Pulse Oximeter
Jiangsu Yuyue Medical Equipment & 510(k) NO: K212385(Traditional)
ATTN: Yuzhuo  Wang                PHONE NO : 86 0511 86900827 
Yunyang Industrial Park           SE DECISION MADE: 16-AUG-22
Danyang  CN 212300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
Sri Trang Gloves (Thailand) Public510(k) NO: K212482(Abbreviated)
ATTN: Jarinya  Jirokjul           PHONE NO : 66 74 344677 
10 SOi 10 Phetkasem Road          SE DECISION MADE: 09-AUG-22
Hatyai  TH 90110                  510(k) STATEMENT
                                                    

DEVICE: Jeesung Safety Syringe and Single Use Needles
JeeSung Medical Co., Ltd.         510(k) NO: K212518(Special)
ATTN: Choi Yong Hyun              PHONE NO : 82 42 9326061 
54, Mujini 1-gil, Daedeok-gu      SE DECISION MADE: 18-AUG-22
Daejeon  KR 34340                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
Advcare Medical                   510(k) NO: K212525(Traditional)
ATTN: Meng T. Tan                 PHONE NO : 626 2023457 
No. 36, Sinsing Street, Shulin DisSE DECISION MADE: 19-AUG-22
New Taipei  TW 23877              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bonvadis Topical Cream
StemCyte Inc.                     510(k) NO: K212554(Traditional)
ATTN: Angel  Hsieh                PHONE NO : 886 934 051402 
13800 Live Oak Avenue             SE DECISION MADE: 19-AUG-22
Baldwin Park CA  91706            510(k) STATEMENT
                                                    

DEVICE: UniVit HE, UniVit UHS
VisionCare Devices, LLC.          510(k) NO: K212763(Traditional)
ATTN: Rick  Morgan                PHONE NO : 1 530 3642271 
6100 Bellevue Lane                SE DECISION MADE: 10-AUG-22
Anderson CA  96007                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TightRail Guardian Motorized Dilator Sheath
Spectranetics, Inc.               510(k) NO: K212784(Traditional)
ATTN: Jordan  Baum                PHONE NO : 719 2470183 
9965 Federal Drive                SE DECISION MADE: 24-AUG-22
Colorado Springs CO  80921        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XLase Plus
Biotec Italia, SRL                510(k) NO: K212790(Traditional)
ATTN: Edoardo  Milanello          PHONE NO : 39 0444 591683 
Viale della Repubblica 20, 36031  SE DECISION MADE: 15-AUG-22
Dueville (VI)  IT                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MONOFIX PGCL, knotless wound closure device
Samyang Holdings Corp., Ltd.      510(k) NO: K212810(Traditional)
ATTN: Ahram  Kim                  PHONE NO : 82 42 9303134 
55, Munpyeongseo-ro, 18beon-gil   SE DECISION MADE: 05-AUG-22
Daedeok-gu  KR 34302              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
Jiangsu Jichun Medical Devices Co.510(k) NO: K212846(Traditional)
ATTN: Zhu  Pingnan                PHONE NO : 86 519 88906510 
 NO.98, Baiyang Bridge, Zhenglu ToSE DECISION MADE: 30-AUG-22
Changzhou  CN 213111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iClean Viral Transport System (VTM-RT kit)
Huachenyang (Shenzhen) Technology 510(k) NO: K212856(Third Party - Traditional)
ATTN: Robin  Chu                  PHONE NO : 86 133 92812025 
F8/Bldg 4, Hengchangrong High InduSE DECISION MADE: 18-AUG-22
Shenzhen  CN 518103               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Sotair Device
Safe BVM Corporation              510(k) NO: K212905(Traditional)
ATTN: Haris  Shekhani             PHONE NO : 314 973 6606
1120 Weidman Road                 SE DECISION MADE: 18-AUG-22
Chesterfield MO  63017            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KDL Safety Needles
Shanghai Kindly Enterprise Develop510(k) NO: K212972(Traditional)
ATTN: Liu  Huarong                PHONE NO : 86 021 69118232 
No. 658 Gaochao Road              SE DECISION MADE: 18-AUG-22
Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Aligner
Shenzhen Meiming Dentistry Technol510(k) NO: K213026(Traditional)
ATTN: Fei  Hu                     PHONE NO : 86 132 19006323 
Floor 3, Buliding D, Fuxinlin InduSE DECISION MADE: 16-AUG-22
Shenzhen  CN 518102               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2.1 x 255mm Drill, 22mm Stop
Biomet Micofixation               510(k) NO: K213072(Traditional)
ATTN: Mark  Wladkowski            PHONE NO : 904 3623940 
1520 Tradeport Drive              SE DECISION MADE: 23-AUG-22
Jacksonville FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Auxilock Draw Tight Suture-Based Anchor
Auxein Medical Private Limited    510(k) NO: K213109(Traditional)
ATTN: Rahul  Luthra               PHONE NO : 91 971 7586969 
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 22-AUG-22
Sonipat  IN 131028                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Benchmark BMX96 Access System
Penumbra, Inc.                    510(k) NO: K213390(Traditional)
ATTN: Buu Buu Ly                  PHONE NO : 510 9902332 
One Penumbra Place                SE DECISION MADE: 18-AUG-22
Alameda CA  95132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL ReadiPlasTin
Instrumentation Laboratory Co.    510(k) NO: K213426(Traditional)
ATTN: Carol  Marble               PHONE NO : 781 8614467 
180 Hartwell Road                 SE DECISION MADE: 16-AUG-22
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Root ZX3
J. Morita USA, Inc.               510(k) NO: K213477(Traditional)
ATTN: Fujio  Zushi                PHONE NO : 949 5819600 
9 Mason                           SE DECISION MADE: 03-AUG-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vented Vial Adapter 20mm
West Pharma Services IL, Ltd.     510(k) NO: K213513(Traditional)
ATTN: llanit  Goldgraber          PHONE NO : 972 0 9777866 
4 Hasheizaf St                    SE DECISION MADE: 31-AUG-22
Ra'anana  IL 4366411              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXIR-CX
Radisen Co., Ltd                  510(k) NO: K213520(Traditional)
ATTN: John  Lim                   PHONE NO : 82 31 80849762 
B-602, Hifield Building, 66, BeolmSE DECISION MADE: 19-AUG-22
Anyang-si  KR 14058               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CytonPro-5000
Cytonsys Inc                      510(k) NO: K213524(Traditional)
ATTN: Li-Da  Huang                PHONE NO : 737 2310369 
7801 N. Lamar Blvd, ste C-59      SE DECISION MADE: 10-AUG-22
Austin TX  78752                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORUM
Carl Zeiss Meditec AG             510(k) NO: K213527(Traditional)
ATTN: Stefan  Wimmer              PHONE NO : 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 15-AUG-22
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVA RESIN dual cure, self adhesive resin cement
Imicryl Dis Malzemeleri Sanayi Ve 510(k) NO: K213609(Traditional)
ATTN: Hüsamettin  Sonmez          PHONE NO : 0090 444 7130 
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 09-AUG-22
Konya  TR 42030                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cannulated Screws
Maxxion Medical, LLC              510(k) NO: K213614(Traditional)
ATTN: Guilherme Esteves Pontes    PHONE NO : 55 19 38057693 
201, South Biscayne Boulevard, SuiSE DECISION MADE: 03-AUG-22
Miami FL  33131                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.            510(k) NO: K213645(Traditional)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 08-AUG-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKOUT Software
Iterative Scopes Inc.             510(k) NO: K213686(Traditional)
ATTN: Daniel  Wang                PHONE NO : 703 3430143 
14 Arrow St, 3rd Floor            SE DECISION MADE: 12-AUG-22
Cambridge MA  02138               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI-Rad Companion (Pulmonary)
Siemens Healthcare GmBh           510(k) NO: K213713(Traditional)
ATTN: Lauren  Bentley             PHONE NO : 610 2416736 
40 Liberty Blvd. Mail Code 65-1   SE DECISION MADE: 11-AUG-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOL-GUARD Safety Pull Button Collection Set
Sol-Millennium Medical, Inc.      510(k) NO: K213718(Traditional)
ATTN: PJ  Pasia                   PHONE NO : 847 3631264 
315 Shawnee North Drive           SE DECISION MADE: 30-AUG-22
Suwanee GA  30024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dS Sentinelle Breast 16ch 3.0T Coil
Invivo Corporation (Business Trade510(k) NO: K213727(Traditional)
ATTN: Ann  Lebar                  PHONE NO : 414 2176244 
3545 SW 47th Ave                  SE DECISION MADE: 08-AUG-22
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dS Sentinelle Breast 16ch 1.5T Coil
Invivo Corporation (Business Trade510(k) NO: K213735(Traditional)
ATTN: Ann  Lebar                  PHONE NO : 414 2176244 
3545 SW 47th Ave                  SE DECISION MADE: 08-AUG-22
Florida FL  32608                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lexa PLUS RIS-311
W&H Sterilization s.r.l.          510(k) NO: K213758(Traditional)
ATTN: Paola  Zampino              PHONE NO : 39 0356 663011 
Via Bolgara, 2                    SE DECISION MADE: 19-AUG-22
Brusaporto  IT 24060              510(k) STATEMENT
                                                    

DEVICE: Unispace SA Cervical Cage
Edisoninno Co., Ltd.              510(k) NO: K213791(Traditional)
ATTN: So-yeon  Jang               PHONE NO : 82 31 8606836 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 05-AUG-22
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StimOnTM Pain Relief System (GM2439)
Gimer Medical Co., Ltd.           510(k) NO: K213802(Traditional)
ATTN: Rex  Chang                  PHONE NO : 886 22 6972680 801
9F.-5 and 9F.-8, No. 97, Sec. 1, XSE DECISION MADE: 26-AUG-22
New Taipei City  TW 22175         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
Prosidyan, Inc                    510(k) NO: K213803(Traditional)
ATTN: Charanpreet S. Bagga        PHONE NO : 908 5173666 
41 Spring Street Suite #107       SE DECISION MADE: 23-AUG-22
New Providence NJ  07974          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeRO Graft
Merit Medical Systems, Inc.       510(k) NO: K213845(Traditional)
ATTN: Susan  Christensen          PHONE NO : 801 2084789 
1600 West Merit Parkway           SE DECISION MADE: 15-AUG-22
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spineology Navigation Instruments
Spineology Inc.                   510(k) NO: K213876(Traditional)
ATTN: Andrew  Adams               PHONE NO : 651 2568534 
7800 3rd Street North, Suite 600  SE DECISION MADE: 05-AUG-22
Saint Paul MN  55128              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ONX Large External Fixation System
OrthoNovis, Inc.                  510(k) NO: K213905(Traditional)
ATTN: Ken  West                   PHONE NO : 352 8073306 
1 Hargrove Grade, 2F              SE DECISION MADE: 25-AUG-22
Palm Coast FL  32137              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
O & M Halyard, Inc.               510(k) NO: K213929(Abbreviated)
ATTN: Steven  Dowdley             PHONE NO : 678 4518062 
1 Edison Drive                    SE DECISION MADE: 01-AUG-22
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Percent Oxygen Sensors
CareOx, LLC                       510(k) NO: K213933(Traditional)
ATTN: Young  Kim                  PHONE NO : 848 7021234 
103 Carnegie Center, Suite 300    SE DECISION MADE: 19-AUG-22
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pro Guard Nitrile Powder Free Examination Glove
Medical Glove Co., Ltd            510(k) NO: K213934(Traditional)
ATTN: Teoh  Choh Shee             PHONE NO : 66 98 0166138 
288, Moo 7, Tambon                SE DECISION MADE: 06-AUG-22
Lam Thap  TH 81190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
O & M Halyard, Inc.               510(k) NO: K213937(Abbreviated)
ATTN: Steven  Dowdley             PHONE NO : 678 4518062 
1 Edison Drive                    SE DECISION MADE: 16-AUG-22
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
Careglove Global SDN BHD          510(k) NO: K213993(Traditional)
ATTN: Lim  Kwee Shyan             PHONE NO : 60 6 6782377 
Lot 17479, Lorong Senawang 2/3, OfSE DECISION MADE: 05-AUG-22
Seremban  MY 70450                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
ConMed Corporation                510(k) NO: K214058(Traditional)
ATTN: Kavita  Amin                PHONE NO : 508 9482084 
525 French Road                   SE DECISION MADE: 26-AUG-22
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
Intuitive Surgical, Inc.          510(k) NO: K214095(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 909 5252027 
1266 Kifer Road, Building 101     SE DECISION MADE: 15-AUG-22
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Riva Cem Automix
SDI Limited                       510(k) NO: K214118(Traditional)
ATTN: Antonella  Kotefski         PHONE NO : 61 387 277111 
3-15 Brunsdon Street              SE DECISION MADE: 30-AUG-22
Bayswater  AU 3153                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories Inc.         510(k) NO: K220001(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 04-AUG-22
Poway CA  92064                   510(k) STATEMENT
                                                    

DEVICE: Viramed Borrela All-In-One ViraChip Test Kit
Viramed Biotech AG                510(k) NO: K220016(Traditional)
ATTN: Martin  Kintrup             PHONE NO : 49 89 899336 
Behringstrasse 11                 SE DECISION MADE: 19-AUG-22
Planegg  DE 82152                 510(k) STATEMENT
                                                    

DEVICE: iStent infinite Trabecular Micro-Bypass System, Model iS3
Glaukos Corporation               510(k) NO: K220032(Traditional)
ATTN: David S. Fernquist          PHONE NO : 949 3679600 1257
229 Avenida Fabricante            SE DECISION MADE: 02-AUG-22
San Clemente CA  92672            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
DK Medivision Co., Ltd.           510(k) NO: K220045(Traditional)
ATTN: Henry  Hong                 PHONE NO : 82 415810100 
23 Busong 1-gil, jiksan-eup       SE DECISION MADE: 05-AUG-22
Chungcheongnam-do  KR 31038       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin IPS Distraction
KLS Martin L.P.                   510(k) NO: K220050(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 904 6417746 8005
11201 Saint Johns Industrial ParkwSE DECISION MADE: 11-AUG-22
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable, vinyl examination gloves, Yellow
Dezhou Hengchang Medical Technolog510(k) NO: K220055(Traditional)
ATTN: Jing  Li                    PHONE NO : 86 159 63319855 
West Side of South Tiandingfeng RoSE DECISION MADE: 25-AUG-22
Dezhou City  CN 251500            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSyncWave
iMediSync Inc.                    510(k) NO: K220056(Traditional)
ATTN: Seung  Wan Kang             PHONE NO : 82 2 7477422 
3rd FL. 175 Yeoksam-ro, Gangnam-guSE DECISION MADE: 10-AUG-22
Seoul  KR 06247                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Insulin Syringes
Berpu Medical Technology Co., Ltd.510(k) NO: K220061(Traditional)
ATTN: David  Yu                   PHONE NO : 86 188 68131179 
No. 14 Xingji Road, Yongxiing StreSE DECISION MADE: 23-AUG-22
Wenzhou  CN 325000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgery Mask, Model:2626-7
Dongguan Missadola Technology Co.,510(k) NO: K220067(Traditional)
ATTN: Adeline  Hong               PHONE NO : 86 769 88878117 
F4,bloc 1,No.289,Nanhuang Road,ZhoSE DECISION MADE: 30-AUG-22
Dongguan  CN 523000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMICRYL Composite, Composite Flow Materials
IMICRYL DIS MALZEMELERI SANAYI VE 510(k) NO: K220077(Traditional)
ATTN: Husamettin  Sonmez          PHONE NO : 444 7130144 
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 09-AUG-22
Konya  TR 42030                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visibly Digital Acuity Product
Visibly, Inc.                     510(k) NO: K220090(Traditional)
ATTN: Paul  Foley                 PHONE NO : 217 9714852 
207 E Ohio Street, #233           SE DECISION MADE: 12-AUG-22
Chicago IL  60611                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Xiros Ltd                         510(k) NO: K220091(Traditional)
ATTN: Steve  Curran               PHONE NO : 44 113 2387200 
Springfield House Lane, WhitehouseSE DECISION MADE: 26-AUG-22
Leeds  GB LS17 7UE                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QScreen
PATH MEDICAL GmbH                 510(k) NO: K220139(Traditional)
ATTN: Johann  Oswald              PHONE NO : 49 89 80076502 
Landsberger Strasse 65            SE DECISION MADE: 03-AUG-22
Germering  DE 82110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
Shanghai AnQing Medical Instrument510(k) NO: K220159(Traditional)
ATTN: Shuwen  Fan                 PHONE NO : 86 021 61117375 
3 & 4 Floor, No.2 Building, 366 HuSE DECISION MADE: 26-AUG-22
Shanghai  CN 201201               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Her-2, ER, PR IHControls
Boston Cell Standards, Inc.       510(k) NO: K220163(Traditional)
ATTN: Steven  Bogen               PHONE NO : 617 6365422 
35 Cheryl Drive                   SE DECISION MADE: 15-AUG-22
Sharon MA  02067-1118             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX Enteric Parasite Panel
Becton, Dickinson and Company     510(k) NO: K220193(Traditional)
ATTN: Joseph  Basore              PHONE NO : 616 3014068 
7 Loveton Circle                  SE DECISION MADE: 19-AUG-22
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Examination Gloves
Fujian Jixiang Medical Technology 510(k) NO: K220237(Traditional)
ATTN: Jiatian  Yang               PHONE NO : 86 597 6856383 
29 Tingzhou Avenue, Cewu Town, ChaSE DECISION MADE: 01-AUG-22
Longyan  CN 366399                510(k) STATEMENT
                                                    

DEVICE: “POINT” Kinguide Robotic-Assisted Surgical System
Point Robotics MedTech Inc.       510(k) NO: K220241(Traditional)
ATTN: Wayne  Kao                  PHONE NO : 886 2 29130272 165
7F., No.219, Sec.3, Beixin Rd., XiSE DECISION MADE: 09-AUG-22
New Taipei City  TW 231           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
Siemens Healthcare Diagnostics, In510(k) NO: K220262(Traditional)
ATTN: Amy  Tyler                  PHONE NO : 610 8361390 
500 GBC Drive, P.O. Box 6101 Mail SE DECISION MADE: 26-AUG-22
Newark DE  19714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Picosecond Laser System (Model PS10-A and PS10-B)
Beijing ADSS Development Co., Ltd.510(k) NO: K220268(Traditional)
ATTN: Song  Ying                  PHONE NO : 86 130 51615111 
F2,Building 1,Jinyuan Road 36 DaxiSE DECISION MADE: 23-AUG-22
Beijing  CN 102628                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrow Stiffening Stylet
Arrow International, LLC (a subsid510(k) NO: K220280(Traditional)
ATTN: Fallon  Young               PHONE NO : 610 9847188 
3015 Carrington Mill Blvd         SE DECISION MADE: 30-AUG-22
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Endoscope Injection Needle
Yangzhou Fartley Medical Instrumen510(k) NO: K220292(Traditional)
ATTN: Tina  Han                   PHONE NO : 0086 150 51101225 
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 19-AUG-22
Yangzhou  CN 225106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MDHearingAid app, MDHearingAid Smart hearing aids
MDHearingAid                      510(k) NO: K220303(Traditional)
ATTN: Doug  Breaker               PHONE NO : 844 9443277 
150 N Michigan Avenue Suite 400   SE DECISION MADE: 04-AUG-22
Chicago IL  60601                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Monitor: RespArray
Edan Instruments, Inc.            510(k) NO: K220308(Traditional)
ATTN: Joan.  Wei                  PHONE NO : 86 755 84513592 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 11-AUG-22
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G-CAM
Graphenano Dental S.L.            510(k) NO: K220329(Abbreviated)
ATTN: Maria Simon Garcia          PHONE NO : 34 965 108102 
C/ Pablo Casals , 13 Ba.          SE DECISION MADE: 16-AUG-22
Yecla  ES 30510                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TeraRecon Neuro
TeraRecon, Inc                    510(k) NO: K220349(Traditional)
ATTN: Michael  Sosebee            PHONE NO : 704 6516828 
4309 Emperor Blvd.                SE DECISION MADE: 12-AUG-22
Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedCAD AccuShape Titanium Patient-Specific Cranial Implant
MedCAD                            510(k) NO: K220357(Traditional)
ATTN: Brian  Buss                 PHONE NO : 214 4538864 
501 S 2nd Ave, Suite A-1000       SE DECISION MADE: 26-AUG-22
Dallas TX  75226                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VPS Rhythm DLX Device with TipTracker Technology
Arrow International, LLC (a subsid510(k) NO: K220363(Traditional)
ATTN: Elizabeth  Duncan           PHONE NO : 866 2466990 
3015 Carrington Mill Blvd         SE DECISION MADE: 22-AUG-22
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intense Pulsed Light Equipment
Beijing Globalipl Development Co.,510(k) NO: K220385(Traditional)
ATTN: Jun  Liu                    PHONE NO : 86 151 69727366 
F-8 Qunyinghui Building, Jinyuan RSE DECISION MADE: 12-AUG-22
Beijing  CN 102628                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Blood Lancets
Suzhou Kyuan Medical Apparatus Co.510(k) NO: K220387(Traditional)
ATTN: Shi  Ye                     PHONE NO : 86 512 65995113 
Beiqiao Town                      SE DECISION MADE: 17-AUG-22
Suzhou  CN                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartAdjust(TM) technology
Insulet Corporation               510(k) NO: K220394(Traditional)
ATTN: Alexander  Hamad            PHONE NO : 978 6002432 
100 Nagog Park                    SE DECISION MADE: 19-AUG-22
Acton MA  01720                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vibe SF Self-Fitting Hearing Aid
WSAUD A/S                         510(k) NO: K220403(Traditional)
ATTN: Kristine Klitgaard Pedersen PHONE NO : 0045 21370938 
Nymollevej 6                      SE DECISION MADE: 12-AUG-22
Lynge  DK 3540                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Application Software (VE21)
Siemens Medical Solution USA, Inc.510(k) NO: K220433(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 678 5758832 
40 Liberty Boulevard              SE DECISION MADE: 16-AUG-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Eye (TS-905)
The Standard Co., Ltd.            510(k) NO: K220434(Traditional)
ATTN: Sung Nam Kim                PHONE NO : 
120, Gunpocheomdansaneop 2-ro     SE DECISION MADE: 12-AUG-22
Gunpo-si  KR 15880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
Materialise NV                    510(k) NO: K220452(Traditional)
ATTN: Jenny  Jones                PHONE NO : 32 16 396611 
Technologielaan 15                SE DECISION MADE: 17-AUG-22
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEUWAVE Microwave Ablation System and Accessories
NeuWave Medical Inc.              510(k) NO: K220472(Traditional)
ATTN: Mohamed  Shariff            PHONE NO : 856 4499609 
3529 Anderson Street              SE DECISION MADE: 11-AUG-22
Madison WI  53704                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
Well-Life Healthcare Limited      510(k) NO: K220524(Traditional)
ATTN: Jenny  Hsieh                PHONE NO : 886 2 22266981 
6F., No.168, Lide St., Jhonghe DisSE DECISION MADE: 04-AUG-22
New Taipei City  TW 23512         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tetragraph Neuromuscular Transmission Monitor
Senzime AB                        510(k) NO: K220530(Traditional)
ATTN: Johanna  Faris              PHONE NO : 46 70 5286330 
Ulls vag 41                       SE DECISION MADE: 17-AUG-22
Uppsala  SE 75651                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FAMA Male Latex Condoms
Shanghai Personage Hygiene Product510(k) NO: K220576(Traditional)
ATTN: Haijiang  Song              PHONE NO : 86 021 69214099 
88 Tianchen Road                  SE DECISION MADE: 05-AUG-22
Qingpu District  CN 201700        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearCalc Model RADCA V2
Radformation, Inc.                510(k) NO: K220582(Traditional)
ATTN: Kurt  Sysock                PHONE NO : 844 7233675 
335 Madison Avenue, 4th floor     SE DECISION MADE: 22-AUG-22
New York NY  10017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearCheck Model RADCC V2
Radformation, Inc.                510(k) NO: K220583(Traditional)
ATTN: Kurt  Sysock                PHONE NO : 844 7233675 
335 Madison Avenue, 4th floor     SE DECISION MADE: 23-AUG-22
New York NY  10017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AutoContour Model RADAC V2
Radformation, Inc.                510(k) NO: K220598(Traditional)
ATTN: Kurt  Sysock                PHONE NO : 844 7233675 
335 Madison Avenue, 4th floor     SE DECISION MADE: 24-AUG-22
New York NY  10017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Safety Hypodermic Needle
Hantech Medical Device Co., Ltd.  510(k) NO: K220603(Traditional)
ATTN: Arnold  YANG                PHONE NO : 86 189 17368988 
No 288, Sanheng Road Changhe IndusSE DECISION MADE: 23-AUG-22
Ningbo  CN 315326                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SaliPen
Saliwell Ltd.                     510(k) NO: K220618(Traditional)
ATTN: Ben  Beiski                 PHONE NO : 972 50 7256338 
3A Hatamar St.                    SE DECISION MADE: 30-AUG-22
Harutzim  IL 6091700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bifix Hybrid Abutment Cement
VOCO GmbH                         510(k) NO: K220640(Traditional)
ATTN: M. Th. Plaumann             PHONE NO : 49 4721 719219 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 23-AUG-22
Cuxhaven  DE 27472                510(k) STATEMENT
                                                    

DEVICE: GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Vascular Solutions LLC            510(k) NO: K220647(Special)
ATTN: Steph  Pahl                 PHONE NO : 763 7622641 
6464 Sycamore Court N             SE DECISION MADE: 18-AUG-22
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMF ASP System
VHA DEAN                          510(k) NO: K220648(Traditional)
ATTN: Beth  Ripley                PHONE NO : 858 2043375 
810 Vermont Ave NW                SE DECISION MADE: 11-AUG-22
Washington DC  20420              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blood Pressure Monitor
Guangdong Transtek Medical Electro510(k) NO: K220676(Traditional)
ATTN: Ada  Liang                  PHONE NO : 86 157 28668528 
Zone A, No.105, Dongli Road, TorchSE DECISION MADE: 29-AUG-22
Zhongshan  CN 528437              510(k) STATEMENT
                                                    

DEVICE: Denture Base Polymers
Shandong Huge Dental Material Corp510(k) NO: K220680(Traditional)
ATTN: Maggie  Zheng               PHONE NO : 086 633 2277268 
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 12-AUG-22
Rizhao City  CN 276800            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uCerv Flux-C 3D Porous Titanium Cervical Interbody
Ulrich Medical USA                510(k) NO: K220696(Traditional)
ATTN: Hans  Stover                PHONE NO : 636 5190268 
18221 Edison Avenue               SE DECISION MADE: 19-AUG-22
Chesterfield MO  63005            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
Stryker                           510(k) NO: K220731(Traditional)
ATTN: Gregg  Ritter               PHONE NO : 352 4942122 
325 Corporate Drive               SE DECISION MADE: 11-AUG-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Consolidated HC Steam Sterilizer
Consolidated Machine Corp.        510(k) NO: K220736(Abbreviated)
ATTN: Arthur  Trapotsis           PHONE NO : 617 7826072 
3 Enterprise Rd, Suite C          SE DECISION MADE: 01-AUG-22
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K-SHIELD Zen
SB-Kawasumi Laboratories, Inc.    510(k) NO: K220799(Traditional)
ATTN: Shiro  Agehama              PHONE NO : 81 44 5899750 
3-15-4 Tonomachi, Kawasaki-ku, KawSE DECISION MADE: 29-AUG-22
Kanagawa  JP 210-8602             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DynaClip® Bone Staple
MedShape, Inc.                    510(k) NO: K220812(Traditional)
ATTN: Courtney  Kline             PHONE NO : 727 5436624 
1575 Northside Dr. NW, Suite 440  SE DECISION MADE: 19-AUG-22
Atlanta GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BruxZir NOW
Prismatik Dentalcraft, Inc.       510(k) NO: K220816(Traditional)
ATTN: So Hyun  Park               PHONE NO : 949 8635479 
2144 Michelson Drive              SE DECISION MADE: 02-AUG-22
Irvine CA  96212                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrainsWay Deep TMS System
BrainsWay Ltd.                    510(k) NO: K220819(Traditional)
ATTN: Ahava  Stein                PHONE NO : 972 2 5283040 
19 Hartom St. (Bynet Bldg) Har HotSE DECISION MADE: 26-AUG-22
Jerusalem  IL 9777518             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arkligners
Arklign Laboratories              510(k) NO: K220835(Traditional)
ATTN: Rex  Ho                     PHONE NO : 800 3611659 
2526 Qume Dr Suite 15             SE DECISION MADE: 12-AUG-22
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
Innovasis, Inc.                   510(k) NO: K220875(Traditional)
ATTN: Marshall  McCarty           PHONE NO : 1 801 2612236 
614 E 3900 S                      SE DECISION MADE: 26-AUG-22
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mini-ClotTriever Thrombectomy System
Inari Medical                     510(k) NO: K220887(Traditional)
ATTN: Ellen  Nguyen               PHONE NO : 949 4184127 
6001 Oak Canyon, Suite 100        SE DECISION MADE: 04-AUG-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Brain Biopsy Needle 2.0
PAJUNK GmbH Medizintechnologie    510(k) NO: K220897(Traditional)
ATTN: Christian G. H. Quass       PHONE NO : 49 077 049291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 17-AUG-22
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Blood Collection Needles with/without Needle Holder
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K220900(Traditional)
ATTN: Bingyi  Xiang               PHONE NO : 86 556 5129666 
No.2 Guanyin Road, Taihu Economic SE DECISION MADE: 10-AUG-22
Anqing  CN 246400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WebCeph
AssembleCircle Corp.              510(k) NO: K220903(Traditional)
ATTN: Jang Hoon Kim               PHONE NO : 82 31 6970433 
R02-ho 8th Floor, 12, DaewangpangySE DECISION MADE: 17-AUG-22
Seongnam-si  KR 13487             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical image processing software
Hangzhou Deepwise & league of PHD 510(k) NO: K220910(Traditional)
ATTN: Hailong  Xu                 PHONE NO : 86 1352 1047585 
Room 705, Building 8, 1818-2 WenyiSE DECISION MADE: 11-AUG-22
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QT Scanner 2000 Model A
QT Imaging, Inc.                  510(k) NO: K220933(Traditional)
ATTN: John  Klock                 PHONE NO : 415 3022048 
3 Hamilton Landing, Suite 160     SE DECISION MADE: 31-AUG-22
Novato CA  94949                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OR3O Dual Mobility System
Smith & Nephew, Inc.              510(k) NO: K220959(Traditional)
ATTN: Rose  Beifuss               PHONE NO : 385 2532551 
7135 Goodlett Farms Parkway       SE DECISION MADE: 18-AUG-22
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
Shenzhen Kentro Medical Electronic510(k) NO: K220998(Traditional)
ATTN: Zewu  Zhang                 PHONE NO : 86 0755 33825998 
2nd Floor No 11,Shanzhuang Road, XSE DECISION MADE: 24-AUG-22
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
Spinal Simplicity LLC             510(k) NO: K221023(Traditional)
ATTN: Adam  Rogers                PHONE NO : 913 4514414 
6363 College Blvd, Ste 320        SE DECISION MADE: 19-AUG-22
Overland Park KS  66211           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Allmed Medical (Hubei) Protective 510(k) NO: K221027(Traditional)
ATTN: Vince  Tian                 PHONE NO : 86 717 4215906 
No.29 Dong Hu Road, Majiadian TownSE DECISION MADE: 12-AUG-22
Zhijiang  CN 443299               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
Jiangxi AICARE Medical Technology 510(k) NO: K221040(Traditional)
ATTN: Lizhu  Xiao                 PHONE NO : 86 135 30821218 
No.6, South Side of Nanhuan Road QSE DECISION MADE: 31-AUG-22
Fuzhou  CN 344300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zavation VariSync Plate System and VariSync Spacer System
Zavation Medical Products, LLC    510(k) NO: K221049(Traditional)
ATTN: Katie  Motley               PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 12-AUG-22
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viz RV/LV
Viz.ai, Inc.                      510(k) NO: K221100(Traditional)
ATTN: Vi  Ma                      PHONE NO : 626 2363138 
201 Mission Street, 12th Floor    SE DECISION MADE: 29-AUG-22
San Francisco CA  94105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Actera™ hip system
Conformis Inc.                    510(k) NO: K221104(Traditional)
ATTN: Mary  Kruitwagen            PHONE NO : 781 3459038 
600 Technology Park Drive, 4th FloSE DECISION MADE: 04-AUG-22
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Mydriatic Retinal Camera NW500
Topcon Corporation                510(k) NO: K221111(Traditional)
ATTN: Ryota  Kitawaki             PHONE NO : 81 3 35582915 
75-1 Hasunuma-Cho                 SE DECISION MADE: 29-AUG-22
Itabashi-Ku  JP 174-8580          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
Biosense Webster, Inc.            510(k) NO: K221112(Traditional)
ATTN: Phuong  Park                PHONE NO : 949 9234238 
31 Technology Drive, Suite 200    SE DECISION MADE: 17-AUG-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MANTIS Clip
Boston Scientific Corporation     510(k) NO: K221124(Traditional)
ATTN: Jia  Huang                  PHONE NO : 617 9820126 
100 Boston Scientific Way         SE DECISION MADE: 04-AUG-22
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets
Owen Mumford Ltd                  510(k) NO: K221126(Traditional)
ATTN: Darren  Mansell             PHONE NO : 44 0 1993812021 
Brook Hill                        SE DECISION MADE: 12-AUG-22
Woodstock  GB OX20 1TU            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tasso+
Tasso, Inc.                       510(k) NO: K221131(Traditional)
ATTN: Trish  Kan Brown            PHONE NO : 206 8224186 
1631 15th Ave W, Suite 105        SE DECISION MADE: 12-AUG-22
Seattle WA  98119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Exam Gloves (Blue, Black)
Hebei Astro Medical Supply Co., Lt510(k) NO: K221143(Traditional)
ATTN: Ning  Zheng                 PHONE NO : 86 311 85125369 
East of Xiaoxixian, West of JingsaSE DECISION MADE: 25-AUG-22
Jinzhou  CN 052260                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JR Medic
JR Engineering & Medical Technolog510(k) NO: K221157(Abbreviated)
ATTN: Ganesan  Subramaniam        PHONE NO : 603 605 72081 
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 30-AUG-22
Hulu Selangor  MY 44200           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
Hong Seng Gloves SDN BHD          510(k) NO: K221164(Traditional)
ATTN: Zahari Bin Darus            PHONE NO : 604 04 4211555 
Lot 97, Jalan 10, Kawasan PerusahaSE DECISION MADE: 30-AUG-22
Sungai Petani  MY 08000           510(k) STATEMENT
                                                    

DEVICE: Erbe's Tubing/Cap Sets
Erbe USA, Inc.                    510(k) NO: K221177(Traditional)
ATTN: Jeff  Dill                  PHONE NO : 770 9554400 
2225 Northwest Parkway            SE DECISION MADE: 11-AUG-22
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OLIZ LTB-1000A
LTBIO Co., Ltd.                   510(k) NO: K221189(Traditional)
ATTN: Min-Ho  Kim                 PHONE NO : 82 31 6081058 
1058, B-dong, Seongnam SKV1 Tower,SE DECISION MADE: 29-AUG-22
Seongnam-si  KR 13201             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K221190(Traditional)
ATTN: Sulgue  Choi                PHONE NO : 425 281 9898
22010 South East 51st Street      SE DECISION MADE: 16-AUG-22
Issaquah WA  98029                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compass Steerable Needle
Serpex Medical, Inc.              510(k) NO: K221206(Traditional)
ATTN: Sasha  Schrode              PHONE NO : 609 2549932 
3350 Scott Blvd, Suite 37B        SE DECISION MADE: 25-AUG-22
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upper Arm Blood Pressure Monitor
Shenzhen Yolanda Technology Co., L510(k) NO: K221212(Traditional)
ATTN: Xuejun  Wang                PHONE NO : 86 755 21635022 
Room 201, Jinfulai Building, No.49SE DECISION MADE: 26-AUG-22
Shenzhen  CN 518000               510(k) STATEMENT
                                                    

DEVICE: EnSite X EP System
Abbott                            510(k) NO: K221213(Traditional)
ATTN: Alexandra  Agre             PHONE NO : 651 7564147 
One St. Jude Medical Drive        SE DECISION MADE: 18-AUG-22
St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REAL INTELLIGENCE CORI
Blue Belt Technologies, Inc.      510(k) NO: K221224(Traditional)
ATTN: Corrine  Herlinger          PHONE NO : 412 6833844 4128
2905 Northwest Blvd., Ste. 40     SE DECISION MADE: 19-AUG-22
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Ultrasonic Endoscope EG-740UT
FUJIFILM Corporation              510(k) NO: K221238(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 19-AUG-22
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
Kerr Corporation                  510(k) NO: K221255(Traditional)
ATTN: Haiyan  Wei                 PHONE NO : 714 5167710 
1889 W Mission Blvd               SE DECISION MADE: 31-AUG-22
Pomona CA  91766                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Recon Steerable Sheath
Serpex Medical, Inc.              510(k) NO: K221302(Traditional)
ATTN: Sasha  Schrode              PHONE NO : 609 2549932 
3350 Scott Blvd, Suite 37B        SE DECISION MADE: 15-AUG-22
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONDUIT Lateral Switch Plate
Medos International, SARL         510(k) NO: K221325(Traditional)
ATTN: LiJuan  He                  PHONE NO : 978 4067629 
Chemin-Blanc 38                   SE DECISION MADE: 25-AUG-22
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bloomi Smooth Water Based Lubricant
The Bloomi Inc..                  510(k) NO: K221328(Traditional)
ATTN: Rebecca  Story              PHONE NO : 1 510 4105570 
74 Royal Ridge Court              SE DECISION MADE: 04-AUG-22
Alamo CA  94507                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avéli
Revelle Aesthetics, Inc.          510(k) NO: K221336(Traditional)
ATTN: Melissa  Viotti             PHONE NO : 650 3365985 
2570 W. El Camino Real, Suite 310 SE DECISION MADE: 05-AUG-22
Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transpara 1.7.2
ScreenPoint Medical B.V.          510(k) NO: K221347(Traditional)
ATTN: Robin  Barwegen             PHONE NO : 31 242 020020 
Mercator II, 7th floor, TeornooiveSE DECISION MADE: 03-AUG-22
Nijmegen  NL 6525EC               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Rubberex Alliance Products Sdn Bhd510(k) NO: K221350(Traditional)
ATTN: Sabri Bin Abdul Hamid       PHONE NO : 60 554 82723 
Lot 138201 Off 3/4 Mile, Jalan BerSE DECISION MADE: 05-AUG-22
Ipoh  MY 31400                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS
Qura S.r.l.                       510(k) NO: K221353(Special)
ATTN: Raffaella  Tommasini        PHONE NO : 39 0535 1803050 
Via di Mezzo 23                   SE DECISION MADE: 18-AUG-22
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LapBox Tissue Containment Removal System
ARK Surgical, Ltd.                510(k) NO: K221365(Traditional)
ATTN: Stav  Tori                  PHONE NO : 972 4 6098600 
13 Wadi El Hadj                   SE DECISION MADE: 25-AUG-22
Nazareth  IL                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KDG Abutments
Keystone Dental Inc.              510(k) NO: K221381(Traditional)
ATTN: Nancy  DeAngelo             PHONE NO : 1 781 3283660 
154 Middlesex Turnpike            SE DECISION MADE: 10-AUG-22
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
Ovesco Endoscopy AG               510(k) NO: K221385(Traditional)
ATTN: Marc O. Schurr              PHONE NO : 49 7071 98979121 
Friedrich-Miescher-Straße 9       SE DECISION MADE: 11-AUG-22
Tuebingen  DE 72076               510(k) STATEMENT
                                                    

DEVICE: Cortera Spinal Fixation System
Surgalign Spine Technologies      510(k) NO: K221403(Traditional)
ATTN: Jessica  Jho                PHONE NO : 801 4559267 
520 Lake Cook Road Suite 315      SE DECISION MADE: 19-AUG-22
Deerfield IL  60015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neurophet SCALE PET
NEUROPHET, Inc.                   510(k) NO: K221405(Traditional)
ATTN: Boreum  Yoo                 PHONE NO : 82 269 547971 
12F, 124, Teheran-ro, Gangnam-gu  SE DECISION MADE: 05-AUG-22
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Safety Syringes for Single Use
Shanghai Kindly Enterprise Develop510(k) NO: K221416(Traditional)
ATTN: Liu  Hualong                PHONE NO : 86 6911 82328125 
No. 658 Gaochao Road              SE DECISION MADE: 31-AUG-22
Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V-Laser
WON TECH Co., Ltd.                510(k) NO: K221427(Special)
ATTN: Hyun  Sik Yoon              PHONE NO : 82 10 67505346 
64 Techno 8-ro, Yuseong-Gu        SE DECISION MADE: 24-AUG-22
Daejeon  KR 34028                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Customize
3D-Side SA                        510(k) NO: K221432(Traditional)
ATTN: Laurent  Paul               PHONE NO : 32 0 10813548 
Rue Andre Dumont 5                SE DECISION MADE: 03-AUG-22
Mont-Saint-Guibert  BE 1435       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL hair removal
Shenzhen Lizbella Technology Co.,L510(k) NO: K221451(Traditional)
ATTN: Shiwei  Zhang               PHONE NO : 89 0755 23194813 
No.1202, C Block, 3rd Building, HuSE DECISION MADE: 01-AUG-22
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
Shenzhen Century Dongyuan Technolo510(k) NO: K221466(Special)
ATTN: He  Wang                    PHONE NO : 86 1379 8450554 
Floor 2, Building B1, Gonghe FourtSE DECISION MADE: 12-AUG-22
Shenzhen  CN 518104               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INHANCETM Reverse Glenoid Peripheral Posts
Depuy Ireland UC                  510(k) NO: K221467(Traditional)
ATTN: Yayoi  Fujimaki             PHONE NO : 508 8283541 
Loughbeg                          SE DECISION MADE: 31-AUG-22
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyClearALIGN Dental Aligner System
Key Dental Technologies, LLC      510(k) NO: K221475(Traditional)
ATTN: Larry  Moray                PHONE NO : 919 2592280 
920 MLK Blvd Suite 920-B          SE DECISION MADE: 31-AUG-22
Chapel Hill NC  27517             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex FiberTape and TigerTape Cerclage Sutures
Arthrex Inc.                      510(k) NO: K221485(Traditional)
ATTN: Kelsey N. Roberts           PHONE NO : 1 239 6435553 72257
1370 Creekside Boulevard          SE DECISION MADE: 22-AUG-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INDEX BPM
Ya Horng Electronic Co., Ltd.     510(k) NO: K221486(Traditional)
ATTN: Jerry  Hsu                  PHONE NO : 8866 593 2201 441
No.35, Shalun, Anding Dist.       SE DECISION MADE: 30-AUG-22
Taiwan  TW 745                    510(k) STATEMENT
                                                    

DEVICE: NEOVEIL Staple Line Reinforcement
Gunze Limited                     510(k) NO: K221487(Special)
ATTN: Hidenori  Nishioka          PHONE NO : 81 773 428035 
46 Natsumegaichi, Aono            SE DECISION MADE: 26-AUG-22
Ayabe, Kyoto  JP 623-8513         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Blood Lancet
SteriLance Medical (Suzhou) Inc.  510(k) NO: K221507(Traditional)
ATTN: Susan  Sun                  PHONE NO : 86 512 65799308 
No.168 PuTuoShan Road, New DistricSE DECISION MADE: 31-AUG-22
Suzhou  CN 215153                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Miro3D Wound Matrix
Reprise Biomedical, Inc.          510(k) NO: K221520(Traditional)
ATTN: Herzog  Kathy               PHONE NO : 612 7994562 
17400 Medina Road Suite 100       SE DECISION MADE: 18-AUG-22
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
Edwards Lifesciences, LLC         510(k) NO: K221528(Traditional)
ATTN: Mahvish  Iqbal              PHONE NO : 949 2504994 
1 Edwards Way                     SE DECISION MADE: 22-AUG-22
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LimFlow ARC
LimFlow, Inc.                     510(k) NO: K221541(Traditional)
ATTN: Zachary  Woodson            PHONE NO : 1 707 3286522 
3031 Tisch Way - 110 Plaza West   SE DECISION MADE: 31-AUG-22
San Jose CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OneTouch Delica Plus Lancing System
Asahi Polyslider Co., Ltd.        510(k) NO: K221546(Traditional)
ATTN: Yoshitaka  Akagi            PHONE NO : 81 867 421171 
860-2 Misaki                      SE DECISION MADE: 23-AUG-22
Maniwa  JP 719-3226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-ray Flat Panel Detectors (CareView 1800 RF)
CareRay Digital Medical Technology510(k) NO: K221549(Traditional)
ATTN: Xu  Wei                     PHONE NO : 86 512 86860288 
A2-201/B3-501, Biobay,218 Xinghu SSE DECISION MADE: 01-AUG-22
Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K221599(Traditional)
ATTN: Jee Young  Ju               PHONE NO : 82 2 21940861 
3366, Hanseo-ro, Nam-myeon,       SE DECISION MADE: 22-AUG-22
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafetiHeel, MediHeel, Novaplus
NSP Tech Pte Ltd                  510(k) NO: K221604(Traditional)
ATTN: HC  Tan                     PHONE NO : 65 981 80450 
10 Admiralty Street,   #02-06 NortSE DECISION MADE: 22-AUG-22
Singapore  SG 757695              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
CAF Medical Solutions Inc.        510(k) NO: K221616(Traditional)
ATTN: Oscar Arriaga Yamin         PHONE NO : 1 713 6147049 
17539 Roberts Road                SE DECISION MADE: 01-AUG-22
Hockley TX  77477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
Brainlab AG                       510(k) NO: K221618(Traditional)
ATTN: Chiara  Cunico              PHONE NO : 49 8999 15680 
Olof-Palme-Str.9                  SE DECISION MADE: 30-AUG-22
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: exGraft, exGraft Carbon
PECA Labs                         510(k) NO: K221628(Traditional)
ATTN: Doug  Bernstein             PHONE NO : 877 842 2873 
4424 Penn Ave, Suite 201          SE DECISION MADE: 04-AUG-22
Pittsburgh PA  15224              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL sapphire ice cooling hair remove device
Shenzhen Desida Technology Co., Lt510(k) NO: K221635(Traditional)
ATTN: Shuangcheng  Yuan           PHONE NO : 86 755 28227189 
5th Floor, Building A, Sanmin InduSE DECISION MADE: 31-AUG-22
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Iconic Latex Glove
Iconic medicare sdn bhd           510(k) NO: K221648(Traditional)
ATTN: Tan Cho Chia                PHONE NO : 60 4 504159 
PMT 798, Lingkaran Cassia Selatan,SE DECISION MADE: 25-AUG-22
Batu Kawan  MY 14110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Impression Material
Chemoment Materials Co.,ltd       510(k) NO: K221668(Traditional)
ATTN: Mabel  Lu                   PHONE NO : 86 551 62329017 
No. 546-549, Renhe Industry Town SSE DECISION MADE: 08-AUG-22
Hefei  CN 230081                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CellFX® System
Pulse Biosciences, Inc.           510(k) NO: K221671(Traditional)
ATTN: Punam  Gollamudi            PHONE NO : 415 3054404 
3957 Point Eden Way               SE DECISION MADE: 01-AUG-22
Hayward CA  94545                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InstaFill Graft Delivery System, SIGNIFY Bioactive
Globus Medical Inc.               510(k) NO: K221737(Traditional)
ATTN: Jennifer  Antonacci         PHONE NO : 610 9301800 1861
2560 General Armistead Ave.       SE DECISION MADE: 11-AUG-22
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Posterior Spinal Fixation System
Shanghai REACH Medical Instrument 510(k) NO: K221745(Special)
ATTN: Mingsha  Ye                 PHONE NO : 86 021 54840582 
Building 13, No.999 Jiangyue Road SE DECISION MADE: 31-AUG-22
Shanghai  CN 201114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NextGen Pedicle Screw System
CoreLink, LLC                     510(k) NO: K221776(Traditional)
ATTN: Steven  Mounts              PHONE NO : 888 3497808 
2072 Fenton Logistics Park        SE DECISION MADE: 09-AUG-22
St. Louis MO  63026               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TCL3 Motion Tracking System
TracInnovations A/S               510(k) NO: K221785(Traditional)
ATTN: Stefan  Glimberg            PHONE NO : 45 53 798545 
Brydehusvej 13                    SE DECISION MADE: 29-AUG-22
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRIS Pi Q switched Nd YAG laser
Bio-Med USA Inc                   510(k) NO: K221789(Traditional)
ATTN: Young  Chi                  PHONE NO : 973 2785222 
27 New England Dr                 SE DECISION MADE: 09-AUG-22
Ramsey NJ  07446                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acute QC Strut and Components
Smith & Nephew, Inc.              510(k) NO: K221792(Traditional)
ATTN: Amanda  Lammey              PHONE NO : 901 8331364 
7135 Goodlett Farms Parkway       SE DECISION MADE: 25-AUG-22
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315
Cipher Surgical Limited           510(k) NO: K221824(Special)
ATTN: Justin  Buch                PHONE NO : 44 2477 170700 
The Venture Centre, Sir William LySE DECISION MADE: 19-AUG-22
Coventry  GB CV4 7EZ              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
Cordis US Corp.                   510(k) NO: K221832(Traditional)
ATTN: Luis  Davila                PHONE NO : 52 656 1707011 04587
14201 N.W. 60th Avenue            SE DECISION MADE: 22-AUG-22
Miami Lakes FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
Integra Lifesciences Corporation  510(k) NO: K221835(Traditional)
ATTN: Alexandra  Wells            PHONE NO : 609 9036300 
1100 Campus Road                  SE DECISION MADE: 22-AUG-22
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask  (HNFM0103)
Shanghai Hua En Industrial CO LTD 510(k) NO: K221838(Traditional)
ATTN: Lisa  Zhao                  PHONE NO : 86 156 18875177 
#30, NO988 Hui Ji Road, Xuanqiao TSE DECISION MADE: 17-AUG-22
Shanghai  CN 201314               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TDM Lumbar Interbody Fusion Cage System
TDM Co., Ltd                      510(k) NO: K221844(Traditional)
ATTN: Jung Wook  Choi             PHONE NO : 82 62 9717460 
69, Cheomdan Venture So-ro 37 beonSE DECISION MADE: 17-AUG-22
Gwangju  KR 61003                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
Centinel Spine LLC                510(k) NO: K221848(Traditional)
ATTN: Jessica  Staub              PHONE NO : 
900 Airport Road, Suite 3B        SE DECISION MADE: 19-AUG-22
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMK 3D Metal Tibial Tray
Medacta International S.A.        510(k) NO: K221850(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060___ 
Strada Regina                     SE DECISION MADE: 23-AUG-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
Shockwave Medical, Inc.           510(k) NO: K221852(Traditional)
ATTN: Danica  Van                 PHONE NO : 408 5804471 
5403 Betsy Ross Dr                SE DECISION MADE: 16-AUG-22
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocesses Umbilical Cable
Innovative Health, LLC.           510(k) NO: K221854(Traditional)
ATTN: Rick  Ferreira              PHONE NO : 877 4003740 
1435 North Hayden Road Suite 100  SE DECISION MADE: 06-AUG-22
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
Healstone Biotech Inc             510(k) NO: K221871(Traditional)
ATTN: Bryan  Fang                 PHONE NO : 604 8002434 
Unit 650 - 655 West Kent Avenue NoSE DECISION MADE: 30-AUG-22
Vancouver  CA V6P 6T7             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
CAF Medical Solutions Inc.        510(k) NO: K221879(Traditional)
ATTN: Oscar Arriaga Yamin         PHONE NO : 1713 6147049 
17539 Roberts Road                SE DECISION MADE: 10-AUG-22
Hockley TX  77477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stent Positioning Assistance System (SPAS)
Seven Sons Ltd.                   510(k) NO: K221917(Traditional)
ATTN: Nancy  Zhang                PHONE NO : 31 640 845545 
65 Yigal Alon Street              SE DECISION MADE: 19-AUG-22
Tel Aviv  IL 67443                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Small Fragment System
Jeil Medical Corporation          510(k) NO: K221920(Traditional)
ATTN: Bora  Kim                   PHONE NO : 82 2850 3533 
702, 703, 704, 705, 706, 804, 805,SE DECISION MADE: 24-AUG-22
Seoul  KR 08378                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscope Model EG-580UT and Endoscope Model EG-580UR
FUJIFILM Corporation              510(k) NO: K221952(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 04-AUG-22
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo CARESCAPE SpO2 – Masimo with SpHb
Masimo Corporation                510(k) NO: K221953(Special)
ATTN: Unji  Lee                   PHONE NO : 949 5637426 
52 Discovery                      SE DECISION MADE: 04-AUG-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
RealCloud Imaging Inc. dba RealClo510(k) NO: K221955(Traditional)
ATTN: Douglas A Golay             PHONE NO : 712 3013882 
2625 North Loop Drive, Suite 2130 SE DECISION MADE: 31-AUG-22
Ames IA  50010                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINQ II Insertable Cardiac Monitor
Medtronic, Inc.                   510(k) NO: K221962(Traditional)
ATTN: Dianna L. Johannson         PHONE NO : 763 5262376 
8200 Coral Sea Street NE MS-MVS11 SE DECISION MADE: 25-AUG-22
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lancing device
SteriLance Medical(Suzhou) Inc.   510(k) NO: K221970(Traditional)
ATTN: Susan  Sun                  PHONE NO : 86 051265 7993089294 
No.168 PuTuoShan Road             SE DECISION MADE: 30-AUG-22
Suzhou  CN 215153                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasound Transmission Gels
Hony Medical Co., Ltd.            510(k) NO: K221999(Traditional)
ATTN: Zhu  Huina                  PHONE NO : 86 159 16327827 
No.12,9Road,Changlong Ind.Zone,   SE DECISION MADE: 30-AUG-22
Taishan  CN 529222                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dolphin Imaging 12.0
Patterson Dental Supply, Inc      510(k) NO: K222072(Special)
ATTN: Erin  Daly                  PHONE NO : 608 3454888___ 
Dolphin Imaging & Management SolutSE DECISION MADE: 08-AUG-22
Chatsworth CA  91311              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
Carlsmed, Inc.                    510(k) NO: K222082(Special)
ATTN: Karen  Liu                  PHONE NO : 760 7661926 
1800 Aston Ave., Ste 100          SE DECISION MADE: 12-AUG-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LimFlow V-Ceiver
LimFlow Inc.                      510(k) NO: K222083(Third Party - Traditional)
ATTN: Zachary  Woodson            PHONE NO : 1 707 3286522 
3031 Tisch Way - 110 Plaza West   SE DECISION MADE: 09-AUG-22
San Jose CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 1688 4K Camera System with Advanced Imaging Modality
Stryker                           510(k) NO: K222130(Special)
ATTN: Marlene  Fraga              PHONE NO : 928 2949043 
5900 Optical Court                SE DECISION MADE: 19-AUG-22
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzDent-i / E2 / Prora View/ Smart M Viewer
Ewoosoft Co., Ltd                 510(k) NO: K222145(Traditional)
ATTN: Young Seok Kim              PHONE NO : 82 31 80156172 
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 12-AUG-22
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Knotless FiberTak Biceps Suture Anchor
Arthrex Inc.                      510(k) NO: K222161(Special)
ATTN: Kelsey N Roberts            PHONE NO : 1 239 6435553 72257
1370 Creekside Boulevard          SE DECISION MADE: 11-AUG-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FairFix Adjustable Button System
Medacta International SA          510(k) NO: K222169(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 16-AUG-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MI View&GO
Siemens Medical Solutions USA, Inc510(k) NO: K222172(Special)
ATTN: Clayton  Ginn               PHONE NO : 865 8982692 
810 Innovation Drive              SE DECISION MADE: 19-AUG-22
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Baby Gorilla®/Gorilla® Plating System
Paragon 28, Inc.                  510(k) NO: K222194(Special)
ATTN: Haylie  Hertz               PHONE NO : 303 7200017 
14445 Grasslands Drive            SE DECISION MADE: 19-AUG-22
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ivWatch Model 400
ivWatch, LLC                      510(k) NO: K222212(Special)
ATTN: Holly  Novak                PHONE NO : 855 4892824 7046
700 Tech Center Parkway, Suite 300SE DECISION MADE: 24-AUG-22
Newport News VA  23606            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
Neuronetics, Inc.                 510(k) NO: K222230(Special)
ATTN: Amanda  Pentecost           PHONE NO : 610 6404202 
3222 Phoenixville Pike            SE DECISION MADE: 24-AUG-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
Bard Access Systems, Inc.         510(k) NO: K222232(Special)
ATTN: Teresa  Do-McCage           PHONE NO : 801 5225959 
605 North 5600 West               SE DECISION MADE: 24-AUG-22
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: miCOR System Lens Fragmentation System
Carl Zeiss Meditec Cataract Techno510(k) NO: K222236(Special)
ATTN: Gary  Mocnik                PHONE NO : 949 4330413 
8748 Technology Way               SE DECISION MADE: 24-AUG-22
Reno NV  89521                    510(k) STATEMENT
                                                    

DEVICE: SmartBolus Calculator
Insulet Corporation               510(k) NO: K222239(Traditional)
ATTN: Alexander  Hamad            PHONE NO : 978 6002432 
100 Nagog Park                    SE DECISION MADE: 19-AUG-22
Acton MA  01720                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BonOs® Inject Bone Cement; NEO Pedicle Screw System™
Neo Medical SA                    510(k) NO: K222256(Special)
ATTN: Jonas  Larsson              PHONE NO : 41 79 4440443 
Route de Lausanne 157 A           SE DECISION MADE: 26-AUG-22
Villette (Lavaux)  CH 1096        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
Invivo Corporation (Business Trade510(k) NO: K222257(Third Party - Traditional)
ATTN: Connie  Pascual             PHONE NO : 1 978 6592440 
3545 SW 47th Ave.                 SE DECISION MADE: 23-AUG-22
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Arthrex Self Punching SwiveLock Suture Anchors
Arthrex Inc.                      510(k) NO: K222263(Special)
ATTN: Tiffany  Mentzel            PHONE NO : 1239 6435553 75833
1370 Creekside Boulevard          SE DECISION MADE: 26-AUG-22
Naples FL  34108                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
STERIS Corporation                510(k) NO: K222272(Special)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5960 Heisley Road                 SE DECISION MADE: 18-AUG-22
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FONA XDC
FONA S.r.l                        510(k) NO: K222274(Special)
ATTN: Luigi  Germano              PHONE NO : 39____ 02 45712171__ 
Via G.Galilei 11                  SE DECISION MADE: 23-AUG-22
Assago  IT 20057                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BriefCase
Aidoc Medical, Ltd.               510(k) NO: K222277(Special)
ATTN: Amalia  Schreier            PHONE NO : 972 73 7946870 
3 Aminadav St.                    SE DECISION MADE: 26-AUG-22
Tel Aviv  IL 6706703              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
Corentec Co., Ltd.                510(k) NO: K222278(Special)
ATTN: Yoorim  Bae                 PHONE NO : 82 41 4107116 
12, Yeongsanhong 1-gil, Ipjang-myeSE DECISION MADE: 26-AUG-22
Cheonan-si  KR 31056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rusch Intermittent Urethral Catheters
Teleflex Medical                  510(k) NO: K222279(Special)
ATTN: Kelly  Breheim              PHONE NO : 612 5001344 
3015 Carrington Mill Blvd         SE DECISION MADE: 29-AUG-22
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 8ch Wrist Coil
Invivo Corporation (Business Trade510(k) NO: K222325(Third Party - Traditional)
ATTN: Connie  Pascual             PHONE NO : 1 978 6592440 
3545 SW 47th Ave                  SE DECISION MADE: 31-AUG-22
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DenMat Glutaraldehyde Desensitizer
DenMat Holding, LLC               510(k) NO: K222357(Third Party - Traditional)
ATTN: Murisa  Woodlin             PHONE NO : 805 3463700 2933
1017 W. Central Avenue            SE DECISION MADE: 09-AUG-22
Lompoc CA  93436                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Salvo® Spine System
Spine Wave, Inc.                  510(k) NO: K222362(Special)
ATTN: Ronald K Smith              PHONE NO : 203 7121846 
Three Enterprise Drive, Suite 210 SE DECISION MADE: 29-AUG-22
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K222387(Special)
ATTN: Janine F Reyes              PHONE NO : 714 6697853 
1385 Shimoshigami                 SE DECISION MADE: 31-AUG-22
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TERA HARZ DENTURE
Graphy Inc.                       510(k) NO: K222414(Third Party - Traditional)
ATTN: Tae-woo  Kim                PHONE NO : 82 2 8643056 
603, #617, Ace Gasan Forhu, 225, GSE DECISION MADE: 11-AUG-22
Seoul  KR 08503                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
Better Care Plastic Technology Co.510(k) NO: K222449(Traditional)
ATTN: Zhu  Chunyan                PHONE NO : 86 311 66766067 
Fuqian Xi Road, West district of SSE DECISION MADE: 27-AUG-22
Shenze County  CN 050000          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System,  V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
Steris                            510(k) NO: K222543(Special)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437___ 
5960 Heisley Rd                   SE DECISION MADE: 25-AUG-22
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Pr510(k) NO: K222558(Special)
ATTN: Julie  Villanueva, PhD      PHONE NO : 404 6393851 
1600 Clifton Road NE, MS-H24-11   SE DECISION MADE: 30-AUG-22
Atlanta GA  30329                 510(k) SUMMARY AVAILABLE FROM FDA


                 TOTAL 510(k)s THIS PERIOD   257                                     
                 TOTAL WITH SUMMARIES        244                                     
                 TOTAL WITH STATEMENTS        13
                                      
 
Back to Top