510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2023
DEVICE: Motiva Flora SmoothSilk Tissue Expander
Motiva USA LLC 510(k) NO: K211676(Traditional)
ATTN: Roslyn d'Incelli PHONE NO : 805 4525421
2543 Mesa School Lane SE DECISION MADE: 13-OCT-23
Santa Barbara CA 93109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
Jiangsu Rongye Technology Co., Ltd510(k) NO: K213146(Traditional)
ATTN: Tina Jiang PHONE NO : 86 514 82100330
Touqiao Town, Yangzhou City SE DECISION MADE: 27-OCT-23
Jiangsu CN 225109 510(k) STATEMENT
DEVICE: Antimicrobial Gelling Fiber Dressing with PHMB
Advanced Medical Solutions Ltd. 510(k) NO: K213473(Traditional)
ATTN: Kay McGrath PHONE NO : 44 7791 188193
Premier Park, 33 Road One, WinsforSE DECISION MADE: 26-OCT-23
Winsford GB CW7 3RT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
Randox Laboratories Limited 510(k) NO: K220451(Traditional)
ATTN: Karena Shaw PHONE NO : 44 28 94422413
55 Diamond Road SE DECISION MADE: 05-OCT-23
Crumlin GB BT29 4Qy 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plaxpot Multi Plasma
GCS Co. Limited 510(k) NO: K220493(Traditional)
ATTN: Su Kyung Park PHONE NO : 82 2 551536
#1008, 555, Dunchon-daero, JungwonSE DECISION MADE: 27-OCT-23
Seongnam KR 13215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIdental Symphony Implant System
UNIdental Co., Ltd. 510(k) NO: K221315(Traditional)
ATTN: Nam Kyu Kang PHONE NO : 82 2 8988715
#D-613 GM Techno-park, 60 Haan-ro SE DECISION MADE: 25-OCT-23
Gwangmyeong-si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evidence MultiSTAT DOA Urine MultiPlex
Randox Laboratories Limited 510(k) NO: K221550(Traditional)
ATTN: Karena Shaw PHONE NO : 44 28 94422413
55 Diamond Road SE DECISION MADE: 05-OCT-23
Crumlin GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Newclip Patient-matched instrumentation non sterile PSI
Newclip Technics 510(k) NO: K221615(Traditional)
ATTN: Gaelle Gourbiere PHONE NO : 33 228 213712
P.A. de la Lande Saint Martin - 45SE DECISION MADE: 25-OCT-23
Haute-Goulaine FR 44115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sterile Syringe
Weihai Shengjie Medical Technology510(k) NO: K221777(Traditional)
ATTN: Huihui Wang PHONE NO : 86 0631 5769637
No.58, Chuhe South Road High-Tech SE DECISION MADE: 06-OCT-23
Weihai CN 264210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Warantec Custom Abutment
Warantec Co., Ltd, 510(k) NO: K221972(Traditional)
ATTN: Younggwang Choi PHONE NO : 82 2 62419001
411~412, 474, Dunchon-dearo, JungwSE DECISION MADE: 02-OCT-23
Seongnam-si KR 13229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G4Derm / G4Derm Plus Synthetic Wound Matrix
Gel4Med, Inc. 510(k) NO: K222025(Traditional)
ATTN: Ana Tellechea PHONE NO : 617 6422599
1660 Soldiers Field Rd STE 7 #1063SE DECISION MADE: 11-OCT-23
Brighton MA 02135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APIS (R), VERIS (TM)
SweetBio, Inc 510(k) NO: K222143(Traditional)
ATTN: Kayla Graff PHONE NO : 415 3611649
460 S. Highland St. Floor 2 SE DECISION MADE: 13-OCT-23
Memphis TN 38111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
THI Total Healthcare Innovation Gm510(k) NO: K222214(Traditional)
ATTN: Karl Hintermann PHONE NO : 43 4228 30100 14
Gewerbestrasse 4 SE DECISION MADE: 17-OCT-23
Feistritz im Rosental AT 9181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artemis, Artemis TPO, Artemis MX
Eigen 510(k) NO: K222222(Traditional)
ATTN: William Mandel PHONE NO : 530 2741240 237
13300 Grass Valley Ave Ste A SE DECISION MADE: 12-OCT-23
Grass Valley CA 95945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Centrix FluoroSilver Silver Diamine Fluoride 38%
Centrix Inc 510(k) NO: K222459(Traditional)
ATTN: Greg Moreau PHONE NO : 203 5677444
770 River Rd SE DECISION MADE: 27-OCT-23
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VVR Generator system
Starmed Co., Ltd. 510(k) NO: K222997(Traditional)
ATTN: Honggeun Lee PHONE NO : 82 31 8163546 209
B-Dong, 4F&12F, 158, Haneulmaeul-RSE DECISION MADE: 25-OCT-23
Goyang-si KR 10355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroTrigger Basic (NTB)
NeuroTrigger 510(k) NO: K223027(Traditional)
ATTN: Nikolai Kuincher PHONE NO : 972 5 22963130
Nirim 3 SE DECISION MADE: 10-OCT-23
Tel Aviv IL 67060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgiAid® Collagen Wound Dressing
Maxigen Biotech, Inc. 510(k) NO: K223126(Traditional)
ATTN: Cheng-Han Chou PHONE NO : 886 3 3287222 1251
No. 88, Keji 1st Rd., Guishan DistSE DECISION MADE: 11-OCT-23
Taoyuan City TW 333411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cold/Hot Compression
JKH Health Co., Ltd. 510(k) NO: K223541(Traditional)
ATTN: Pu Jiang PHONE NO : 0086__ 755 27926589
4-5F, Building 12, Hengmingzhu IndSE DECISION MADE: 27-OCT-23
Shenzhen CN 518104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRALIS HRA+OCT and variants
Heidelberg Engineering GmbH 510(k) NO: K223557(Traditional)
ATTN: Arianna Schoess Vargas PHONE NO : 49 6221 64630
Max-Jarecki Strasse 8 SE DECISION MADE: 20-OCT-23
Heidelberg DE 69115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI compatibility for existing BioHorizons dental implants and abutments
BioHorizons Implant Systems, Inc. 510(k) NO: K223697(Traditional)
ATTN: Paul Leppo PHONE NO : 205 2782520
2300 Riverchase Center SE DECISION MADE: 13-OCT-23
Birmingham AL 35244 510(k) STATEMENT
DEVICE: Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
Jiangsu Konsung Bio-Medical Scienc510(k) NO: K223740(Traditional)
ATTN: Heidi Zhang PHONE NO : 86____ 17722 507195
NO.8, Shengchang West Road, DanyanSE DECISION MADE: 05-OCT-23
Jiangsu CN 212300 510(k) STATEMENT
DEVICE: accufit
Mettler Electronics Corporation 510(k) NO: K223802(Traditional)
ATTN: An Le PHONE NO : 714 5332221
1333 South Claudina Street SE DECISION MADE: 06-OCT-23
Anaheim CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONHAWA Respiratory Humidifier
Telesair, Inc. 510(k) NO: K223863(Traditional)
ATTN: Yong (Bryan) Liu PHONE NO : 714 8516549___
204 Technology Drive, Suite F SE DECISION MADE: 13-OCT-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivio® LVEDP System
Avicena, LLC 510(k) NO: K223905(Traditional)
ATTN: Sean Brady PHONE NO : 626 9563606
117 E. Colorado Blvd., Suite 510 SE DECISION MADE: 06-OCT-23
Pasadena CA 91105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2GATE Lite TM
MegaGen Implant Co. Ltd 510(k) NO: K223909(Traditional)
ATTN: Tae Gyoun Lee PHONE NO : 82 53 2223878
45, Secheon-ro 7-gil, Dasa-eup, DaSE DECISION MADE: 20-OCT-23
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumen 155-SF
Intricon Corporation 510(k) NO: K223911(Traditional)
ATTN: David Akbari PHONE NO : 651 5878347
1260 Red Fox Road SE DECISION MADE: 17-OCT-23
Arden Hills MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
Medimaging Integrated Solution Inc510(k) NO: K223926(Traditional)
ATTN: Jung-Yi Yen PHONE NO : 886 3579 8860 1706
3F., No. 24-2, Industry E. Rd. IV,SE DECISION MADE: 06-OCT-23
Hsinchu CN 30077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® Hypodermic Needle (812402)
PromaMedical Inc. 510(k) NO: K230070(Abbreviated)
ATTN: Christian Wehrenpfenning PHONE NO : 239 8500885___
4585 Ponce De Leon Blvd. Suite 719SE DECISION MADE: 05-OCT-23
Miami FL 33146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFIRA
Medovate Limited 510(k) NO: K230083(Traditional)
ATTN: Alan Finnerty PHONE NO : 44 01223 901991
Camboro Business Park SE DECISION MADE: 31-OCT-23
Girton GB CB3 0QH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lung-CAD
Imagen Technologies, Inc 510(k) NO: K230085(Traditional)
ATTN: Rebecca Jones PHONE NO : 322 2554192
594 Broadway, Suite 701 SE DECISION MADE: 03-OCT-23
New York NY 10012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE Cover
Purgo Biologics Inc. 510(k) NO: K230091(Traditional)
ATTN: Byungsun Kim PHONE NO : 82 70 48270451
#812, 27 Dunchon-daero 457beon-gilSE DECISION MADE: 06-OCT-23
Seongnam-si KR 13219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
Anthogyr 510(k) NO: K230104(Traditional)
ATTN: Estelle Salle PHONE NO : 33 04 50580237
2237 Avenue André Lasquin SE DECISION MADE: 16-OCT-23
Sallanches FR 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital™ Spinal Fixation System
ZimVie Spine (Zimmer Biomet Spine,510(k) NO: K230116(Traditional)
ATTN: Hanna Aucoin PHONE NO : 816 5622948
10225 Westmoor Drive SE DECISION MADE: 11-OCT-23
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuroblade System
ClearMind Biomedical 510(k) NO: K230125(Traditional)
ATTN: Vance Lin PHONE NO : 886 2 22697417
5F, No. 167, Fuxing N. Rd., SongshSE DECISION MADE: 13-OCT-23
Taipei TW 105403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micromate™ Navi+
ISYS Medizintechnik GMBH 510(k) NO: K230130(Traditional)
ATTN: Pedro Costa PHONE NO : 351 91 9073292
Bergwerksweg 21, Salzburg SE DECISION MADE: 10-OCT-23
Kitzbuehel AT 6370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Copioumed Chemotherapy Isolation Gown
Copioumed International Inc. 510(k) NO: K230135(Traditional)
ATTN: James Liu PHONE NO : 886___ 928 644966____
16F-4, No.1, Fuxing N. Rd., SongshSE DECISION MADE: 04-OCT-23
Taipei City TW 105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Denti.AI Detect
Denti.AI Technology, Inc. 510(k) NO: K230144(Traditional)
ATTN: Lyudmila Tuzova PHONE NO : 647 4679741
99 Yorkville Ave, Suite 214 SE DECISION MADE: 06-OCT-23
Toronto CA M5R3k5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vlab
DormoTech Medical Ltd. 510(k) NO: K230148(Traditional)
ATTN: Abed Nassir PHONE NO : 972 54 7955865
Yitzhak Rabin 21 SE DECISION MADE: 11-OCT-23
Afula IL 33704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyOne Sky Spirometer
NDD Medizintechnik AG 510(k) NO: K230178(Traditional)
ATTN: Andreas Senn PHONE NO : 41 44 5126541
Technoparkstrasse 1 SE DECISION MADE: 19-OCT-23
Zurich CH 8005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Byte Aligner System
Dentsply Sirona Inc. 510(k) NO: K230199(Traditional)
ATTN: Sobrin Laura PHONE NO : 717 8494434
221 West Philadelphia Street, SuitSE DECISION MADE: 18-OCT-23
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonix Health
Ontact Health Co., Ltd. 510(k) NO: K230209(Traditional)
ATTN: Hyuk-Jae Chang PHONE NO : 82 2 3629611
5f, 50-5, Ewhayeodae-gil, SeodaemuSE DECISION MADE: 20-OCT-23
Seoul KR KS013/03764 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuViz 128 Multi-Slice CT Scanner System
Neusoft Medical Systems Co., Ltd. 510(k) NO: K230220(Traditional)
ATTN: Tian Yuehui PHONE NO : 86 24 233558105
No. 177-1 Chuangxin Road, Hunnan DSE DECISION MADE: 11-OCT-23
Shenyang CN 110167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoCentric Dental Implant System
OsteoCentric Technologies 510(k) NO: K230242(Traditional)
ATTN: Todd Evans PHONE NO : 435 7572253
75 W 300 N Suite 150 SE DECISION MADE: 05-OCT-23
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ikshana
ImmersiveTouch 510(k) NO: K230249(Traditional)
ATTN: Prashant Banerjee PHONE NO : 773 8405227
910 W Van Buren Street Suite 715 SE DECISION MADE: 16-OCT-23
Chicago IL 60607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
InfoBionic, Inc. 510(k) NO: K230265(Abbreviated)
ATTN: Dave MacCutcheon PHONE NO : 978 6748304
312 Billerica Rd. Office Link #5 SE DECISION MADE: 06-OCT-23
Chelmsford MA 02184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc. 510(k) NO: K230275(Traditional)
ATTN: Brian Ma PHONE NO : 613 6886949 2903
400 College Road East SE DECISION MADE: 27-OCT-23
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICOCLAMP
Kono Seisakusho Co., Ltd 510(k) NO: K230281(Traditional)
ATTN: Aya Takagi PHONE NO : 81 47 3723281
2-11-10 Soya SE DECISION MADE: 23-OCT-23
Ichikawa city JP 272-0837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra LP Coil System
Penumbra, Inc. 510(k) NO: K230284(Traditional)
ATTN: Samyukta Rangachari PHONE NO : 763 7429306
One Penumbra Place SE DECISION MADE: 25-OCT-23
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc 510(k) NO: K230285(Traditional)
ATTN: Jacquelyn Gesumaria PHONE NO : 609 4549384
400 College Road East SE DECISION MADE: 27-OCT-23
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc. 510(k) NO: K230300(Traditional)
ATTN: Brian Ma PHONE NO : 613 6885949 2903
400 College Road East SE DECISION MADE: 27-OCT-23
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
Medtronic Xomed, Inc. 510(k) NO: K230320(Special)
ATTN: Alexandra Oliver PHONE NO : 904 3328936
6743 Southpoint Drive North SE DECISION MADE: 26-OCT-23
Jacksonville FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Speedboat Flush SB1 Instrument
Creo Medical Ltd 510(k) NO: K230328(Traditional)
ATTN: Diane Davis PHONE NO : 44 789 9306000
Unit 2 Beaufort Park, Beaufort ParSE DECISION MADE: 31-OCT-23
Chepstow GB NP16 5UH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tornier Humeral Nail and Tornier Long Humeral Nail
Tornier, Inc. 510(k) NO: K230352(Traditional)
ATTN: Renato Juan PHONE NO : 858 8298987
10801 Nesbitt Ave South SE DECISION MADE: 31-OCT-23
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpotLight/SpotLight Duo (with DLIR option)
Arineta Ltd. 510(k) NO: K230370(Traditional)
ATTN: Tanya Shalem PHONE NO : 011 972 46374000
15 Halamish St. SE DECISION MADE: 13-OCT-23
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mighty Wire Guide Wire
Merit Medical Systems, Inc. 510(k) NO: K230418(Traditional)
ATTN: James Kenny PHONE NO : 353 91 703798
1600 Merit Pkwy Bldg 87 SE DECISION MADE: 28-OCT-23
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert® Xpress CoV-2 plus
Cepheid® 510(k) NO: K230440(Traditional)
ATTN: Suzette Chance PHONE NO : 262 6231775
904 Caribbean Drive SE DECISION MADE: 13-OCT-23
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Empatica S.r.l. 510(k) NO: K230457(Traditional)
ATTN: Alberto Poli PHONE NO : 39 335 6316498
Via Stendhal, 36 SE DECISION MADE: 30-OCT-23
Milan IT 20144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.C. Life 21
21 Equipment S.R.L. 510(k) NO: K230459(Traditional)
ATTN: Dolores Moretto PHONE NO : 39 011 883522
Piazza Bodoni 3 SE DECISION MADE: 19-OCT-23
Torino IT 10123 510(k) STATEMENT
DEVICE: Sonopuls 190
Enraf-Nonius, B.V. 510(k) NO: K230472(Traditional)
ATTN: Thomas Jozef Doodkorte PHONE NO : 31 65159 8044
127, Vareseweg SE DECISION MADE: 24-OCT-23
Rotterdam NL NL-3047AT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oran Park Mask
ResMed Pty Ltd (Registration Numbe510(k) NO: K230476(Traditional)
ATTN: Daniellia Chan PHONE NO : 65 916 97611
1 Elizabeth Macarthur Drive SE DECISION MADE: 19-OCT-23
Bella Vista AU 2153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acro Composites Interbody System
Acro Composites, LLC 510(k) NO: K230478(Traditional)
ATTN: Mitchell Bass PHONE NO :
6950 W Snowville Road SE DECISION MADE: 19-OCT-23
Brecksville OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
Dongguan Hunter Electronic Technol510(k) NO: K230490(Traditional)
ATTN: Hunter Ye PHONE NO : 135 54760590
Room 301, Building 6, 74 Qiaodong SE DECISION MADE: 27-OCT-23
Dongguan City CN 523728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Serena Sleep Night Guard
Meris Investment Group 510(k) NO: K230495(Traditional)
ATTN: Gary Maas PHONE NO : 800 6549842
1145 Quentin Ave S SE DECISION MADE: 13-OCT-23
Lakeland MN 55043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
Jiangsu MaxF Electric Appliance Co510(k) NO: K230500(Traditional)
ATTN: Zhang Jianfang PHONE NO : 86 1596 1228139
NO.12, West Park Road, Rulin Town SE DECISION MADE: 26-OCT-23
Changzhou CN 213200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K3900 Ultrasound Imaging System
MAUI Imaging 510(k) NO: K230511(Traditional)
ATTN: David Specht PHONE NO : 408 3143959
3600 136th Pl SE, Ste 300 SE DECISION MADE: 25-OCT-23
Bellevue WA 98006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
Medline Industries, Inc. 510(k) NO: K230559(Traditional)
ATTN: Nicole Schaffer PHONE NO : 724 6409680
1 Three Lake Drive SE DECISION MADE: 26-OCT-23
Northfiled IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Willow Generation 3 Breast Pump
Willow Innovations, Inc. 510(k) NO: K230570(Traditional)
ATTN: Shruti Jayakumar PHONE NO : 408 3353106
1975 W. El Camino Real, Suite 306 SE DECISION MADE: 16-OCT-23
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hudson RCI® TurboMist™ Nebulizer System
Medline Industries LP 510(k) NO: K230602(Traditional)
ATTN: Lakshmi Kanuri PHONE NO :
Three Lakes Drive SE DECISION MADE: 31-OCT-23
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MegaGen Dental Implant Systems Portfolio - MR Conditional
MegaGen Implant Co., Ltd. 510(k) NO: K230618(Traditional)
ATTN: Hyejin Jung PHONE NO : 82 53 2223865
45, Secheon-ro SE DECISION MADE: 11-OCT-23
Daegu KR 42921 510(k) STATEMENT
DEVICE: BeneHold™ Surgical Incise Drape with CHG antimicrobial II
Avery Dennison Medical Ltd. 510(k) NO: K230645(Traditional)
ATTN: Lisa Bartakovics PHONE NO : 1 312 2066159
IDA Business Park, Ballinalee RoadSE DECISION MADE: 25-OCT-23
Longford IE N39 RC80 510(k) STATEMENT
DEVICE: Monopolar Electrode Surgical Instrument
VHMED (Nantong) Co. Ltd. 510(k) NO: K230650(Traditional)
ATTN: Guan Yunjuan PHONE NO : 86 513 86920166
A1, 173 Ganjiang Road SE DECISION MADE: 12-OCT-23
Tongzhou Bay CN 226332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Zhonghong Pulin Medical Products C510(k) NO: K230662(Traditional)
ATTN: Li Yunjiao PHONE NO : 86 1873 1635203
West Industrial Park, Luannan CounSE DECISION MADE: 26-OCT-23
Tangshan CN 063500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
Central Medicare Sdn. Bhd. 510(k) NO: K230681(Traditional)
ATTN: Chua Kah Ying PHONE NO : 605 6290000
PT 2609-2620, Batu 8, Jalan ChangkSE DECISION MADE: 02-OCT-23
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
Qingdao Kingon Medical Science and510(k) NO: K230702(Traditional)
ATTN: Benrong Zhang PHONE NO : 86 185 65833539
Room 301-302(B), No.15 HanchengRoaSE DECISION MADE: 18-OCT-23
Qingdao Free Trade Zone CN 266555510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Skypro, Surgical Gown 6021
Skypro Medical Supplies Company 510(k) NO: K230707(Traditional)
ATTN: Cyrus Wong PHONE NO : 85 227 110882
C301, Tsing Yi Industrial Centre PSE DECISION MADE: 12-OCT-23
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech® Vantage® Total Ankle System
Exactech, Inc. 510(k) NO: K230717(Traditional)
ATTN: Pedro Ravelo PHONE NO : 352 3771140
2320 NW 66th Ct. SE DECISION MADE: 12-OCT-23
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Macro & Micro-Test HCG Pregnancy Test Midstream
Jiangsu Macro & Micro-Test Med-Tec510(k) NO: K230741(Traditional)
ATTN: Bella Xu PHONE NO : 86 151958 62818
No.888, Zhujiang Road, Juegang StrSE DECISION MADE: 13-OCT-23
Nantong CN 226499 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuEra Tight RF Model OptiStream
BIOS s.r.l. 510(k) NO: K230755(Traditional)
ATTN: Martina De Iturbe PHONE NO : 39 391 7461002
Via Guido Rossa 10/12 SE DECISION MADE: 30-OCT-23
Vimodrone IT 20055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Examination Gloves
3A Glove Sdn. Bhd. 510(k) NO: K230777(Traditional)
ATTN: Kumar Durarajen PHONE NO : 60 127 135040
PTD 2058 & 2059, Jalan Cyber 4, KaSE DECISION MADE: 06-OCT-23
Senai MY 81400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MFG-05
Zimmer MedizinSysteme GmbH 510(k) NO: K230780(Traditional)
ATTN: Ute Killet PHONE NO : 49 731 976162
Junkersstrasse 9 SE DECISION MADE: 05-OCT-23
Neu-Ulm DE 89231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VRNT
CognifiSense, Inc. 510(k) NO: K230814(Traditional)
ATTN: Tassilo Baeuerle PHONE NO : 415 7287775
1271 Lakeside Drive, Suite 3121 SE DECISION MADE: 31-OCT-23
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modius Sleep
Neurovalens Ltd. 510(k) NO: K230826(Traditional)
ATTN: Jason McKeown PHONE NO : 00 447 412508707
8 Carmagrim Road SE DECISION MADE: 27-OCT-23
Portglenone GB BT44 8BP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SignalHF (IM008)
Implicity Inc. 510(k) NO: K230842(Traditional)
ATTN: Caroline Florequin PHONE NO : 33 666 213591
185 Alewife Brook Parkway Suite 21SE DECISION MADE: 25-OCT-23
Cambridge MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EARP Nerve Cuff Electrode
Nvision Biomedical Technologies, I510(k) NO: K230853(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 06-OCT-23
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SwiftMR
AIRS Medical Inc. 510(k) NO: K230854(Traditional)
ATTN: Jihyeon Seo PHONE NO : 8210 3 4462636
13-14F, Keungil Tower, 223, TeheraSE DECISION MADE: 27-OCT-23
Seoul KR 06142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swiss LthoClast Trilogy
EMS Electro Medical Systems SA 510(k) NO: K230893(Traditional)
ATTN: Timothée Deblock PHONE NO : 41 22 9948516
Ch. De la Vuarpilliere 31 SE DECISION MADE: 23-OCT-23
Nyon CH 1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anterion
Heidelberg Engineering GmbH 510(k) NO: K230897(Traditional)
ATTN: Arianna Schoess Vargas PHONE NO : 49 6221 64630
Max-Jarecki-Str. 8 SE DECISION MADE: 11-OCT-23
Heidelberg DE 69115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WeSensor
PICOPACK Inc. 510(k) NO: K230916(Traditional)
ATTN: Dong-Il Kim PHONE NO : 82 423 625050
#106, 91, Sinilseo-ro 85beon-gil, SE DECISION MADE: 10-OCT-23
Daejeon KR 34325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acumen IQ finger cuff
Edwards Lifesciences, LLC 510(k) NO: K230919(Traditional)
ATTN: Anna Hwang PHONE NO : 949 2500902
One Edwards Way SE DECISION MADE: 24-OCT-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terumo Injection Filter Needle (NF-3013RBKE05M)
Terumo Europe N.V. 510(k) NO: K230951(Traditional)
ATTN: Liesbeth Decoster PHONE NO : 324 86 366935
Interleuvenlaan 40 SE DECISION MADE: 18-OCT-23
Leuven BE 3012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zeus Spinal System
Shanghai Sanyou Medical Co, LTD 510(k) NO: K230961(Special)
ATTN: David Fan PHONE NO : 86 215 8389980
385 Huirong Road SE DECISION MADE: 10-OCT-23
Jiading District CN 201815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unicare (K-UNICARE-USA)
TensCare Ltd 510(k) NO: K230983(Traditional)
ATTN: Saskia Eldridge-Hinmers PHONE NO : 44 137 2723434
9 Blenheim Road SE DECISION MADE: 20-OCT-23
Epsom GB KT199BE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Wireless Intraoral X-Ray Sensor
iRay Imaging Technology (Haining) 510(k) NO: K230998(Special)
ATTN: Junjie Qian PHONE NO : 86 0512 53690872
3rd floor, Building 1, No. 2, CaohSE DECISION MADE: 20-OCT-23
Haining CN 314499 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeepTek CXR Analyzer v1.0
DeepTek Medical Imaging Pvt Ltd 510(k) NO: K231001(Traditional)
ATTN: Carrillo Rory PHONE NO : 415 5800916
3rd Floor, Ideas to Impact, PallodSE DECISION MADE: 05-OCT-23
Pune IN 411405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFAI NeuroSuite CT ICH Assessment System
Ever Fortune.AI Co., Ltd. 510(k) NO: K231025(Traditional)
ATTN: Joseph Chang PHONE NO : 866 4 23226363
8F., No. 573, Sec. 2, Taiwan Blvd.SE DECISION MADE: 04-OCT-23
Taichung City TW 403020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
Zhonghong Pulin Medical Products C510(k) NO: K231029(Traditional)
ATTN: Li Yunjiao PHONE NO : 86 1873 1635203
West Industrial Park, Luannan CounSE DECISION MADE: 30-OCT-23
Tangshan CN 063500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc 510(k) NO: K231050(Traditional)
ATTN: Fang Meisong PHONE NO : 86 755 26501548
Room 410,Building A,3rd Sub-park, SE DECISION MADE: 11-OCT-23
Shenzhen CN 518118 510(k) STATEMENT
DEVICE: PERLA® TL Posterior Thoraco-lumbar Fixation System
Spineart SA 510(k) NO: K231069(Traditional)
ATTN: Franck Pennesi PHONE NO : 00 412 25701200
3 Chemin du Pré-Fleuri SE DECISION MADE: 25-OCT-23
Plan-les-Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: All-Suture Anchor
Riverpoint Medical, LLC 510(k) NO: K231078(Traditional)
ATTN: Edwin Anderson PHONE NO : 503 5178001
815 NE 25th Ave SE DECISION MADE: 05-OCT-23
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
Shanghai AnQing Medical Instrument510(k) NO: K231105(Traditional)
ATTN: Shuwen Fan PHONE NO : 86 021 61117375
3 & 4 Floor, No.2 Building, 366 HuSE DECISION MADE: 17-OCT-23
Shanghai CN 201201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Collagen Wound Dressing
Winner Medical Co., Ltd. 510(k) NO: K231152(Traditional)
ATTN: Yi Fu PHONE NO : 86 755 28138888 8717
Winner Industrial Park, No. 660 BuSE DECISION MADE: 12-OCT-23
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shina Syringe; Shina Safety Syringe
Shina Med Corporation 510(k) NO: K231165(Traditional)
ATTN: Tae Joo Ha PHONE NO : 82 318 0572125
455-30. Bogaewonsam-ro, Anseong-siSE DECISION MADE: 27-OCT-23
Anseong-si KR 17509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
DiaSorin Inc. 510(k) NO: K231214(Traditional)
ATTN: Kelly Olien PHONE NO : 715 2205915___
1952 Northwestern Avenue SE DECISION MADE: 27-OCT-23
Stillwater MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Topcon Corporation 510(k) NO: K231222(Traditional)
ATTN: Ryota Kitawaki PHONE NO : 81 3 35582915
75-1 Hasunuma-Cho SE DECISION MADE: 30-OCT-23
Itabashi-Ku JP 174-8580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EConsole1
DRTECH Corporation 510(k) NO: K231225(Traditional)
ATTN: Kim Hanbyul PHONE NO : 82 31 7797790
Suite No. 1, 2 Floor/Suite No. 2, SE DECISION MADE: 18-OCT-23
Seongnam-si KR 13216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
Paragon 28 Inc. 510(k) NO: K231231(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 12-OCT-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultravision2™ System
Alesi Surgical Ltd 510(k) NO: K231238(Traditional)
ATTN: Michele Lucey PHONE NO : 603 7481374
128 Blye Hill Landing SE DECISION MADE: 31-OCT-23
Newbury NH 03255 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Finger Clip Pulse Oximeter
Guangdong Genial Technology Co., L510(k) NO: K231243(Traditional)
ATTN: Yu Jun PHONE NO : 86 13423 669481
I-6-05-02 11th Road,Area B, GuangfSE DECISION MADE: 31-OCT-23
Zhaoqing CN 526437 510(k) STATEMENT
DEVICE: Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
Alesi Surgical Ltd. 510(k) NO: K231298(Traditional)
ATTN: Dominic Griffiths PHONE NO : 44 029 20291022
Cardiff Medicentre, Heath Park SE DECISION MADE: 31-OCT-23
Cardiff GB CF14 4UJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nutricair Enteral Syringe with ENFit
Cair LG 510(k) NO: K231300(Traditional)
ATTN: Irving L. Wiesen, Esq. PHONE NO : 212 3818774
1, Allée des Chevreuls SE DECISION MADE: 06-OCT-23
Lissieu FR 69380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Blood Pressure Monitor
Shenzhen Jumper Medical Equipment 510(k) NO: K231310(Traditional)
ATTN: Danyin Li PHONE NO : 86 755 26696279
D Building, No. 71, Xintian Road, SE DECISION MADE: 27-OCT-23
Shenzhen CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERSEAL Sealer and Divider
Gyrus ACMI, Inc. 510(k) NO: K231327(Traditional)
ATTN: Dolan Mills PHONE NO : 901 3550007
800 West Park Drive SE DECISION MADE: 25-OCT-23
Westborough MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renova Spine Balloon Catheter
Biopsybell s.r.l. 510(k) NO: K231340(Traditional)
ATTN: Carlo Ricca Prandi Bellini PHONE NO : 39 0535 27850
Via A. Manuzio, 24 SE DECISION MADE: 30-OCT-23
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCS Heart Leukocyte Depleting Filter
TransMedics, Inc. 510(k) NO: K231362(Traditional)
ATTN: Miriam Provost PHONE NO : 978 4947897
200 Minuteman Road, Suite 302 SE DECISION MADE: 31-OCT-23
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
Insightec, Ltd. 510(k) NO: K231378(Traditional)
ATTN: Inbal Ben Tzvi PHONE NO : 972 54 2445822
5 Nachum Heth Street SE DECISION MADE: 30-OCT-23
Tirat Carmel IL 39120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Xpress MVP; GeneXpert Xpress System
Cepheid 510(k) NO: K231381(Dual Track)
ATTN: Suzette Chance PHONE NO : 262 6231775
904 Caribbean Drive SE DECISION MADE: 19-OCT-23
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NextDent Base
Vertex-Dental B.V. 510(k) NO: K231388(Abbreviated)
ATTN: Connie Peterse-van der KoppPHONE NO : 31 88 6160412___
Centurionbaan 190 SE DECISION MADE: 20-OCT-23
Soesterberg NL 3769AV 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNO SLA Submerged Narrow Implant System
Cowellmedi Co., Ltd. 510(k) NO: K231395(Traditional)
ATTN: Haejun Lee PHONE NO : 82 51 3142028
48, Hakgam-daero 221beon-gil, SasaSE DECISION MADE: 18-OCT-23
Busan KR 46986 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VUNO Med-DeepBrain
VUNO Inc. 510(k) NO: K231398(Traditional)
ATTN: Jiwon Song PHONE NO : 82 2 5156646
9F, 479, Gangnam-daero, Seocho-gu SE DECISION MADE: 04-OCT-23
Seoul KR 06541 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPD Dental Implant Abutments
Implant Protesis Dental 2004 S.L. 510(k) NO: K231413(Traditional)
ATTN: Francesc Fumanal PHONE NO : 34 93 2788491
Cami del Mig. 71. 1º 2º SE DECISION MADE: 10-OCT-23
Mataro ES 08302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONTAGE-QS Settable, Resorbable Bone Putty
Orthocon, Inc. 510(k) NO: K231475(Traditional)
ATTN: Aniq Darr PHONE NO : 855 4759175
700 Fairfield Avenue - Suite 1 SE DECISION MADE: 12-OCT-23
Stamford CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity CentralStation Wide, Infinity M300, Infinity M300+
Draeger Medical Systems, Inc. 510(k) NO: K231477(Traditional)
ATTN: Deborah Herrington PHONE NO : 978 9356561
6 Tech Drive SE DECISION MADE: 17-OCT-23
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stable-L Standalone Lumbar Interbody System
Nexus Spine, LLC 510(k) NO: K231486(Traditional)
ATTN: Jared Crocker PHONE NO : 801 7025892
2825 East Cottonwood Parkway SuiteSE DECISION MADE: 12-OCT-23
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLink Robotic Navigation Instruments
CoreLink, LLC 510(k) NO: K231494(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park SE DECISION MADE: 27-OCT-23
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Evolve System with the Transform Applicator
InMode Ltd. 510(k) NO: K231495(Traditional)
ATTN: Suhair Francis PHONE NO : 97 249 097470
Tabor Building, Shaar Yokneam POB SE DECISION MADE: 13-OCT-23
Yokneam Iillit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aco Apache Ultrasound System
Aco Healthcare Co., Ltd. 510(k) NO: K231509(Traditional)
ATTN: Henry Huang PHONE NO : 886 3 4391707___
1F, No.8-1, Nandong Rd., Pingzhen SE DECISION MADE: 24-OCT-23
Taoyuan City TW 324 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: tmCMF Solution
TechMah CMF 510(k) NO: K231520(Traditional)
ATTN: Mohamed Mahfouz PHONE NO : 1 865 2004376___
2240 Sutherland Ave, Suite 2 SE DECISION MADE: 02-OCT-23
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: pRESET LITE Thrombectomy Device
phenox Limited 510(k) NO: K231539(Traditional)
ATTN: Rachel McDaid PHONE NO : 353 91 740100
Kamrick Court, Ballybrit Business SE DECISION MADE: 21-OCT-23
Galway IE H91XY38 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: hearOAE
hearX SA (Pty) Ltd 510(k) NO: K231545(Traditional)
ATTN: Seline Van Der Wat PHONE NO : 27 12 0300268
Building 2, Ashlea Gardens Office SE DECISION MADE: 27-OCT-23
Pretoria ZA 0081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sontro® OTC Hearing Aids (AI)
Soundwave Hearing, LLC 510(k) NO: K231550(Traditional)
ATTN: Anthony Florek PHONE NO : 1 708 2057998
619 Enterprise Drive Suite #205 SE DECISION MADE: 26-OCT-23
Oak Brook IL 60253 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stethophone
Sparrow Acoustics Inc. 510(k) NO: K231551(Traditional)
ATTN: Nadia Ivanova PHONE NO : 190 298 93908
2416 Natura Dr SE DECISION MADE: 12-OCT-23
Lucasville CA B4B0X3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
Siemens Medical Solutions USA, Inc510(k) NO: K231560(Traditional)
ATTN: Alina Goodman PHONE NO : 1 317 3718593
40 Liberty Boulevard SE DECISION MADE: 23-OCT-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
Better Care Plastic Technology Co.510(k) NO: K231567(Traditional)
ATTN: Zhu Chunyan PHONE NO : 86 311___ 66179668
Fuqian Xi Road, West district of SSE DECISION MADE: 04-OCT-23
Shenze County CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scenaria View 4.2
Fujifilm Healthcare Americas Corpo510(k) NO: K231574(Traditional)
ATTN: Chaitrali Kulkarni PHONE NO : 704 5174886
81 Hartwell Ave. Suite 300 SE DECISION MADE: 12-OCT-23
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucitone Digital Print Denture System
Dentsply Sirona 510(k) NO: K231578(Abbreviated)
ATTN: Rebecca Sporer PHONE NO : 717 3531150
221 West Philadelphia Street SuiteSE DECISION MADE: 20-OCT-23
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOLLI 2
MOLLI Surgical, Inc. 510(k) NO: K231579(Traditional)
ATTN: Joseph De Croos PHONE NO : 1 833 6655463
50 Wellington Street East Suite 40SE DECISION MADE: 26-OCT-23
Toronto CA M5E 1C8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Breast Pump
Shenzhen Changkun Technology Co., 510(k) NO: K231595(Traditional)
ATTN: Wang Qingpeng PHONE NO : 86 0755 29100487
Room 501, Changkun Technology BuilSE DECISION MADE: 26-OCT-23
Shenzhen CN 518118 510(k) STATEMENT
DEVICE: Standard Staple-Line Reinforcement (SSLR23)
Standard Bariatrics, Inc. 510(k) NO: K231603(Traditional)
ATTN: Trevor Barton PHONE NO : 859 9627619
4300 Glendale Milford Road SE DECISION MADE: 06-OCT-23
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 091 Balloon Guide Catheter
EOSolutions, Corp. 510(k) NO: K231629(Special)
ATTN: Marc Litzenberg PHONE NO : 954 7035271
19700 Sterling Road, Suite 1 SE DECISION MADE: 31-OCT-23
Pembroke Pines FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veuron-Brain-pAb3
Heuron Co., Ltd. 510(k) NO: K231642(Traditional)
ATTN: Lee Hae Ri PHONE NO : 82 2 26338595
10F, C, 150, Yeongdeungpo-ro, YeonSE DECISION MADE: 13-OCT-23
Seoul KR 07292 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEOS Spinal Fixation System
Spineway 510(k) NO: K231658(Traditional)
ATTN: Maurad Ben Mokhtar PHONE NO : 33 614 845362
7 allée Moulin Berger SE DECISION MADE: 10-OCT-23
Ecully FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRRAflow Active Fluid Exchange System (AFES)
IRRAS USA Inc. 510(k) NO: K231664(Traditional)
ATTN: Jeanne S. Warner PHONE NO : 269 2702189
11975 El Camino Real, Suite 304 SE DECISION MADE: 19-OCT-23
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S1
MedPark Co., Ltd. 510(k) NO: K231672(Traditional)
ATTN: Woojong Kim PHONE NO : 82 51 3018777
24, Nakdong-daero 1570 beon-gil, SE DECISION MADE: 13-OCT-23
Buk-gu KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K231685(Traditional)
ATTN: Zhang Yuxi PHONE NO : 86 755 81886120
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 26-OCT-23
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
Life Spine, Inc. 510(k) NO: K231704(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 19-OCT-23
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
AxoGen Corporation 510(k) NO: K231708(Traditional)
ATTN: Shravani Shastry PHONE NO : 888 2964361
13631 Progress Blvd, Ste 400 SE DECISION MADE: 12-OCT-23
Alachua FL 32615-9409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoFlo® HydroPutty™
SurGenTec, LLC 510(k) NO: K231716(Traditional)
ATTN: Travis Greenhalgh PHONE NO : 561 9907882
911 Clint Moore Rd SE DECISION MADE: 02-OCT-23
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
Hunan Life Technology Co., Ltd. 510(k) NO: K231725(Traditional)
ATTN: Fu Wang PHONE NO : 86 1581 5524120
4th floor, Building 10, InnovationSE DECISION MADE: 16-OCT-23
HuNan CN 411199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CleanSeal Advanced Bipolar Vessel Sealer Maryland
Comed Corporation 510(k) NO: K231732(Traditional)
ATTN: Ali AbuSaleh PHONE NO : 708 4074324
525 French Road SE DECISION MADE: 23-OCT-23
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANAX™ 5.5 Spinal System
Innosys Co., Ltd. 510(k) NO: K231737(Special)
ATTN: Hye-Kyung Lee PHONE NO : 82 31 8606839
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 26-OCT-23
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VyLink™ Spinal Screw System
Vy Spine, LLC 510(k) NO: K231744(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 13-OCT-23
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radio Frequency System
Shenzhenshi Sincoheren S&T Develop510(k) NO: K231749(Traditional)
ATTN: Cai Jialong PHONE NO : 86 134 24006986
Floor 4, No 2 plant, No. 14, ZhongSE DECISION MADE: 19-OCT-23
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PodSKAN HF Diagnostic X-ray System
Skanray Technologies Limited 510(k) NO: K231761(Traditional)
ATTN: Vasundhara R PHONE NO : 0821 2415559
Plot#15-17, Hebbal Industrial AreaSE DECISION MADE: 27-OCT-23
Mysore IN 570016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasound System 1300
BK Medical Aps 510(k) NO: K231764(Traditional)
ATTN: Bryan Behn PHONE NO : 26 224 75502
Mileparken 34 SE DECISION MADE: 23-OCT-23
Herlev DK 2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K231772(Traditional)
ATTN: Jee Young Ju PHONE NO : 82 2 21940861
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 03-OCT-23
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiMesh Multiplanar Expandable Interbody Fusion System
Spineology Inc. 510(k) NO: K231781(Special)
ATTN: Andrew Adams PHONE NO : 651 2568534
7800 3rd Street North, Suite 600 SE DECISION MADE: 18-OCT-23
Saint Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
Ulrich Medical USA 510(k) NO: K231809(Traditional)
ATTN: Eric Lucas PHONE NO : 219 5084159
3700 E Plano Parkway Suite 200 SE DECISION MADE: 20-OCT-23
Plano TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ValvuloPro Valvuloplasty Balloon Catheter
Dongguan TT Medical, Inc 510(k) NO: K231814(Traditional)
ATTN: Yuying Bi PHONE NO : 86 1555 3341910
Bld #1, Rm 501, 502, Taoyuan Rd SoSE DECISION MADE: 12-OCT-23
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartBolus Calculator
Insulet Corporation 510(k) NO: K231824(Traditional)
ATTN: Maria Brower PHONE NO : 320 2823005
100 Nagog Park SE DECISION MADE: 18-OCT-23
Acton MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnipod 5 ACE Pump
Insulet Corporation 510(k) NO: K231826(Traditional)
ATTN: Maria Brower PHONE NO : 320 2823005
100 Nagog Park SE DECISION MADE: 18-OCT-23
Acton MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClariVy™ Cervical IBF System
Vy Spine, LLC 510(k) NO: K231836(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866___ 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 30-OCT-23
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProBeam 360° Proton Therapy System v2.0 (Multiroom)
Varian Medical Systems, Inc. 510(k) NO: K231863(Traditional)
ATTN: Peter Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 06-OCT-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Wheelchair (Robooter E40), Model name: BBR-E40-01
Shanghai BangBang Robotics Co., Lt510(k) NO: K231868(Traditional)
ATTN: Liu Canfeng PHONE NO : 86 135 24910052
Room 501, Building 3, No.188 ZhongSE DECISION MADE: 31-OCT-23
Shanghai CN 201613 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOT & T-L Abutment
TruAbutment Inc. 510(k) NO: K231874(Traditional)
ATTN: Ki Yoon Nam PHONE NO : 714 9561488
17666 Fitch SE DECISION MADE: 30-OCT-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAtetracell™-C Titanium Cervical IBF System
Innovasis, Inc. 510(k) NO: K231899(Traditional)
ATTN: Michael Thomas PHONE NO : 801 2612236
614 E 3900 South SE DECISION MADE: 17-OCT-23
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
Ansell Healthcare 510(k) NO: K231902(Traditional)
ATTN: Carson Delaloye PHONE NO : 775 7466600
2301 Robb Drive SE DECISION MADE: 20-OCT-23
Reno NV 89523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Safety Insulin and TB Syringes
Medline Industries, LP 510(k) NO: K231907(Traditional)
ATTN: Kelsey Closen PHONE NO : 847 9492283
Three Lakes Drive SE DECISION MADE: 18-OCT-23
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 45 Micron Polyisoprene Condom
Suretex Limited 510(k) NO: K231908(Traditional)
ATTN: Alison Arnot PHONE NO : 66 772 77400
31/1 Moo 4, Suratthani-Thakuapha RSE DECISION MADE: 27-OCT-23
Tambon Khao Hua Kwai, Amphur Phunp510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIA™ Stapler with Tri-Staple™ Technology
Covidien 510(k) NO: K231934(Traditional)
ATTN: Leo Chen PHONE NO : 86 213 3230182
Rooms 501,502,601,602, No.3 buildiSE DECISION MADE: 27-OCT-23
Min Hang District, Shanghai CN 20510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION® Cement Keel
MicroPort Orthopedics Inc. 510(k) NO: K231947(Traditional)
ATTN: Jonas Susaraba PHONE NO : 901 2905983
5677 Airline Rd SE DECISION MADE: 31-OCT-23
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
AnX Robotica Corporation 510(k) NO: K231960(Traditional)
ATTN: Tim Thomas PHONE NO : 770 4802911
6010 W Spring Creek Parkway SE DECISION MADE: 03-OCT-23
Plano TX 75024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and 510(k) NO: K231965(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
LLC 9900 Innovations Dr. SE DECISION MADE: 30-OCT-23
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStation Cranial Software, v3.1.5 (9735585)
Medtronic Navigation, Inc. 510(k) NO: K231976(Traditional)
ATTN: Rishi Mehta PHONE NO : 720 9605959
200 Medtronic Drive SE DECISION MADE: 19-OCT-23
Lafayette CO 80026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuityUDR
Radmedix LLC 510(k) NO: K231995(Abbreviated)
ATTN: Gabriel Issa PHONE NO : 844 7236334 35
2510 Lance Dr SE DECISION MADE: 25-OCT-23
Dayton OH 45409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iontophoresis Electrodes
TOP-RANK Health Care Co., Ltd. 510(k) NO: K232020(Traditional)
ATTN: Yao Feijie PHONE NO : 86 575 82912999
Mcshan Village, Dongguan Street, SSE DECISION MADE: 16-OCT-23
Shaoxing CN 312352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Momentum Spine
Momentum Health Inc. 510(k) NO: K232023(Traditional)
ATTN: Evan Dimentberg PHONE NO : 514 794 4019
2727 Rue St-Patrick, Apt 109 SE DECISION MADE: 04-OCT-23
Montreal CA H3K0A8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); NexPort™ Trocar System (TS221022); NexPort™ Trocar System (TS241020); NexPort™ Trocar System (TS241021); NexPort™ Trocar System (TS241022); NexPort™ Trocar System (TS331001); NexPort™ Trocar System (TS331002); NexPort™ Trocar System (TS331003); NexPort™ Trocar System (TS331004); NexPort™ Trocar System (TS332001); NexPort™ Trocar System (TS332002); NexPort™ Trocar System (TS332003); NexPort™ Trocar System (TS332004); NexPort™ Trocar System (TS332005); NexPort™ Trocar System (TS332006)
MediConcepts Technology (Shenzhen)510(k) NO: K232042(Traditional)
ATTN: Nick Xu PHONE NO : 86 133 38102750
Building No. 37, Tongfu IndustrialSE DECISION MADE: 20-OCT-23
Shenzhen CN 518120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus Robotic Navigation Instruments
Alphatec Spine, Inc. 510(k) NO: K232044(Traditional)
ATTN: Unnati Bhuptani PHONE NO : 760 3566711
1950 Camino Vida Roble SE DECISION MADE: 06-OCT-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MeVis Liver Suite
MeVis Medical Solutions AG 510(k) NO: K232045(Traditional)
ATTN: Rolf Rzodeczko PHONE NO : 49 0421 22495120
Caroline-Herschel-Strasse 1 SE DECISION MADE: 27-OCT-23
Bremen DE 28359 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
Xeridiem Medical Devices, A Spectr510(k) NO: K232046(Traditional)
ATTN: Steve Murray PHONE NO : 520 8827794 178
4700 S. Overland Dr. SE DECISION MADE: 06-OCT-23
Tucson AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISULAS green
Carl Zeiss Meditec 510(k) NO: K232051(Traditional)
ATTN: Tanesha Bland PHONE NO : 925 2167963
5300 Central Parkway SE DECISION MADE: 24-OCT-23
Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vial Adapter
Shanghai Ling Fu Technology Co., L510(k) NO: K232055(Traditional)
ATTN: Esther Zhang PHONE NO : 0086 137 71505757
4F, No.585-2 Wanyuan Road, MinhangSE DECISION MADE: 06-OCT-23
Shanghai CN 201102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
Dongguan Lide Electric Appliance C510(k) NO: K232056(Traditional)
ATTN: Xiang Guojun PHONE NO : 86 189 98439876
Floor 4, Building 2, No.11 Yinhe FSE DECISION MADE: 06-OCT-23
Dongguan CN 523528 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
Isikel Manufacturing LLC 510(k) NO: K232064(Traditional)
ATTN: Chris Betts PHONE NO : 832 5233027
28350 West Ten Blvd. SE DECISION MADE: 02-OCT-23
Katy TX 77494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
Better Care Plastic Technology Co.510(k) NO: K232070(Traditional)
ATTN: Zhu Chunyan PHONE NO : 86 311 66179668
Fuqian Xi Road, West district of SSE DECISION MADE: 11-OCT-23
Shenze County CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: spineEOS
EOS imaging 510(k) NO: K232086(Traditional)
ATTN: Mathilde Masurel PHONE NO : 33 155 256075
10 rue Mercoeur SE DECISION MADE: 24-OCT-23
Paris FR 75011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOZO Pro
ImpediMed Limited 510(k) NO: K232089(Traditional)
ATTN: Dennis Schlaht PHONE NO : 61 7 38603700
Unit 1 50 Parker Court SE DECISION MADE: 17-OCT-23
Pinkenba AU 4008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO Coconut Hybrid Warming Personal Lubricant
CC Wellness LLC 510(k) NO: K232090(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 11-OCT-23
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO Coconut Hybrid Cooling Personal Lubricant
CC Wellness LLC 510(k) NO: K232091(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 22-OCT-23
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orchid Safety Release ValveTM
Linear Health Sciences LLC 510(k) NO: K232094(Traditional)
ATTN: Daniel Clark PHONE NO : 310 7216222
5333 Wisteria Drive SE DECISION MADE: 03-OCT-23
Oklahoma City OK 73142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - GM Zygomatic Implant System
JJGC Indústria e Comércio de Mater510(k) NO: K232099(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 31-OCT-23
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANDORATE® Valve Kit
GA Health Company Limited 510(k) NO: K232118(Traditional)
ATTN: Cindy Ye PHONE NO : 852 2833 9010 ______
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 16-OCT-23
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLIF Anterior Lag Extension
Medacta International S.A. 510(k) NO: K232123(Traditional)
ATTN: Stefano Baj PHONE NO : 0041 9169 66060
Strada Regina SE DECISION MADE: 18-OCT-23
Castel San Pietro CH 6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
Shenzhen AOJ Medical Technology Co510(k) NO: K232128(Traditional)
ATTN: Jack Wang PHONE NO : 86 755 27786026
Room 301&4F, Blk A, Building A, JiSE DECISION MADE: 14-OCT-23
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Applanation Tonometer HT-5000
Huvitz Co., Ltd. 510(k) NO: K232143(Traditional)
ATTN: Heo Hyung-Min PHONE NO : 82 314 289059
38, 170beon-gil, Burim-ro,Dongan-gSE DECISION MADE: 23-OCT-23
Anyang-si KR 14055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K232145(Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 South East 51st Street SE DECISION MADE: 30-OCT-23
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynamic TiBase
Talladium España, SL 510(k) NO: K232151(Traditional)
ATTN: Xavier Soca Filella PHONE NO : 34 973 289580
Virginia Woolf, 17 SE DECISION MADE: 17-OCT-23
Lleida ES 25005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ascend VBR System, Ascend NanoTec VBR System
Alphatec Spine, Inc. 510(k) NO: K232173(Traditional)
ATTN: Sandy Gill PHONE NO : 1 760 4946633
1950 Camino Vida Roble SE DECISION MADE: 06-OCT-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
bioMerieux, Inc 510(k) NO: K232201(Traditional)
ATTN: Jared Bronson PHONE NO : 314 2018799
595 Anglum Rd. SE DECISION MADE: 23-OCT-23
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set
Vesco Medical, LLC 510(k) NO: K232205(Traditional)
ATTN: Chris O'Keefe PHONE NO : 614 9145991
60 Collegeview Road, Suite 144 SE DECISION MADE: 23-OCT-23
Westerville OH 43081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUNION Sacroiliac Joint Fusion System
Astura Medical 510(k) NO: K232211(Traditional)
ATTN: Parker Kelch PHONE NO : 469 5015530
4949 W Royal Ln. SE DECISION MADE: 24-OCT-23
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlaDuo System
ShenB Co Ltd 510(k) NO: K232223(Traditional)
ATTN: Sunny Kang PHONE NO : 82 70 49122702
ShenB Bldg 148 Seongsui-ro SeongdoSE DECISION MADE: 24-OCT-23
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YJ-K1/K2 Wheelchair (YJ-K1F 16" NDE; YJ-K1F 16" NDS; YJ-K1F 18" NDE; YJ-K1F 18" NDS; YJ-K1F 20" NDE; YJ-K1F 20" NDS; YJ-K1F 18" NDEE; YJ-K1F 16" VDE; YJ-K1F 16" VDS; YJ-K1F 18" VDE; YJ-K1F 18" VDS; YJ-K1F 20" VDE; YJ-K1F 20" VDS; YJ-K2 16" VDFE; YJ-K2 16" VDFS; YJ-K2 18" VDFE; YJ-K2 18" VDFS; YJ-K2 20" VDFE; YJ-K2 20" VDFS; YJ-K1G 18" NFFE; YJ-K1G 18" NFFS; YJ-K2TC 16" NAFE; YJ-K2TC 18" NAFE; YJ-K2TC 20" NAFE)
Zhenjiang Assure Medical Equipment510(k) NO: K232230(Traditional)
ATTN: Ying Mei PHONE NO : 0086 13 85294120
No. 297, Chuqiao Road SE DECISION MADE: 03-OCT-23
Zhenjiang City CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
The Magstim Company Ltd. 510(k) NO: K232235(Traditional)
ATTN: Daniel Gregory PHONE NO : 440 1994 240798
Spring Gardens SE DECISION MADE: 25-OCT-23
Whitland GB SA34 0HR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Echo
Quanta System Spa 510(k) NO: K232236(Traditional)
ATTN: Dario Bandiera PHONE NO : 390 33 1376797
Via Acquedotto, 109 SE DECISION MADE: 20-OCT-23
Samarate IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMDA abutment
Simda Co., Ltd. 510(k) NO: K232271(Traditional)
ATTN: Cha Young Woo PHONE NO : 82 70 42562855
156-4, Gamjeon-dong SE DECISION MADE: 26-OCT-23
Busan KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
Oxoid Limited (Part of Thermo Fish510(k) NO: K232276(Traditional)
ATTN: Amie Lovatt PHONE NO : 44 125 6694376
Wade Road SE DECISION MADE: 06-OCT-23
Basingstoke GB RG24 8PW 510(k) STATEMENT
DEVICE: LifeStyles NRL Textured Condom
Suretex Limited 510(k) NO: K232279(Abbreviated)
ATTN: Alison Arnot PHONE NO : 66 772 77400
31/1 Moo 4, Suratthani-Thakuapha RSE DECISION MADE: 05-OCT-23
Tambon Khao Kwai, Amphur Phunphin 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NextAR™ TSA Platform
Medacta International S.A. 510(k) NO: K232280(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 29-OCT-23
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)
Edwards Lifesciences, LLC 510(k) NO: K232294(Traditional)
ATTN: Varad Raghuwanshi PHONE NO : 949 7564502
One Edwards Way SE DECISION MADE: 31-OCT-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A. 510(k) NO: K232305(Traditional)
ATTN: Kira Morales PHONE NO : 1 484 9019471
40 Liberty Blvd. SE DECISION MADE: 23-OCT-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
Thermo Fisher Scientific 510(k) NO: K232310(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 8718909 322411
One Thermo Fisher Way SE DECISION MADE: 31-OCT-23
Oakwood Village OH 44126 510(k) STATEMENT
DEVICE: VICTORY™ Lumbar Plate System
Globus Medical, Inc 510(k) NO: K232318(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800
Valley Forge Business Center 2560 SE DECISION MADE: 31-OCT-23
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexCath Contour™ Steerable Sheath
Medtronic Inc. 510(k) NO: K232321(Traditional)
ATTN: Kripa Pandya PHONE NO : 612 2424046
8200 Coral Sea Street NE SE DECISION MADE: 31-OCT-23
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear® Pedicle Screw System
Carbofix Orthopedics Ltd. 510(k) NO: K232341(Traditional)
ATTN: Hila Wachsler Avrahami PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 10-OCT-23
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
GE Medical Systems SCS 510(k) NO: K232344(Special)
ATTN: Hubert Welsch PHONE NO : 33 01 30703847
283 Rue De La Miniere SE DECISION MADE: 11-OCT-23
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Expert Access with Remote Scanning
GE Healthcare 510(k) NO: K232346(Traditional)
ATTN: Allena Holzworth PHONE NO : 414 2085162
500 W. Monroe Street SE DECISION MADE: 27-OCT-23
Chicago IL 60661 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
MiRus, LLC 510(k) NO: K232348(Traditional)
ATTN: Jordan Bauman PHONE NO : 404 3458235
1755 West Oak Parkway, Suite 100 SE DECISION MADE: 27-OCT-23
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laser Cap, Model: Hat-01
Hubei YJT Technology Co.,Ltd 510(k) NO: K232356(Traditional)
ATTN: Jiali Xie PHONE NO : 86 153 27223070__
Room1-4 ,8F,Block7,Guannan Fuxing SE DECISION MADE: 24-OCT-23
Wuhan CN 430000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical face mask
Kingstar Medical (Xianning) Co., L510(k) NO: K232359(Traditional)
ATTN: Fan Rong PHONE NO : 86 158 71408114
No.79 Yong'andong Road, Xian'an DiSE DECISION MADE: 02-OCT-23
Xianning CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cmAngio® V1.0
CureMetrix, Inc. 510(k) NO: K232367(Traditional)
ATTN: Kevin Harris PHONE NO : 619 3399889
402 West Broadway Suite # 400 SE DECISION MADE: 05-OCT-23
San Diego CA 92101 510(k) STATEMENT
DEVICE: Actinia® hip stems
implantcast, GmbH 510(k) NO: K232371(Traditional)
ATTN: Juliane Höppner PHONE NO : 49 4161 744135
Lineburger Schanze 26 SE DECISION MADE: 19-OCT-23
21614 Buxtehude DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
ProEdge Dental Products, Inc. 510(k) NO: K232393(Traditional)
ATTN: Mark Frampton PHONE NO : 303___ 8628820___
7042 South Revere Parkway, Suite 4SE DECISION MADE: 27-OCT-23
Centennial CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
bioMérieux 510(k) NO: K232395(Traditional)
ATTN: Sophie Quiblier PHONE NO :
376 Chemin de l'Orme SE DECISION MADE: 05-OCT-23
Marcy-l'Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ OR1™ SCB CONTROL (WU300)
Karl Storz SE & Co. KG 510(k) NO: K232406(Traditional)
ATTN: Thomas Ostrowski PHONE NO : 1 781 9108508
Dr.-Karl-Storz-StraBe 34 SE DECISION MADE: 03-OCT-23
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cautery Protective Actuation System (CPAS)
Safer Surgeries Medical Devices, L510(k) NO: K232407(Traditional)
ATTN: Rowland Grattan PHONE NO : 770 4762702
3883 Rogers Bridge Road Suite 201BSE DECISION MADE: 06-OCT-23
Duluth GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JuggerKnot Soft Anchor OC
Riverpoint Medical, LLC 510(k) NO: K232411(Traditional)
ATTN: Becca DeFrancia PHONE NO : 503 5178001
815 NE 25th Ave SE DECISION MADE: 06-OCT-23
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Titan Dental Design
ClearAdvance, LLC 510(k) NO: K232429(Traditional)
ATTN: Frank Puig PHONE NO : 614 2609849
18 Endeavor, STE 107 SE DECISION MADE: 13-OCT-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid SDH
iSchemaView, Inc. 510(k) NO: K232436(Traditional)
ATTN: Jim Rosa PHONE NO : 303 7043374
1120 Washington Ave. Suite 200 SE DECISION MADE: 25-OCT-23
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paragon 8F Balloon Guide Catheter
Wallaby Medical 510(k) NO: K232437(Traditional)
ATTN: Joseph Tang PHONE NO : 714 9046097
22901 Mill Creek Drive SE DECISION MADE: 13-OCT-23
Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEPRINT® splintmaster
Detax GmbH 510(k) NO: K232448(Traditional)
ATTN: Markus Stratmann PHONE NO : 49 7243 510138
Carl-Zeiss-Strasse 4 SE DECISION MADE: 12-OCT-23
Ettingen DE D-76275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable electrosurgical pencil (MD1000)
Shenzhen Mecun Medical Supply Co.,510(k) NO: K232460(Traditional)
ATTN: Bo Zheng PHONE NO : 86 755 8606220
2nd Level, 2nd Building, Fuqiang SSE DECISION MADE: 11-OCT-23
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vy Spine™ VyLam™ Laminoplasty System
Vy Spine, LLC 510(k) NO: K232471(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 10-OCT-23
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProtekDuo Veno-Venous Cannula Sets
CardiacAssist, Inc. 510(k) NO: K232480(Traditional)
ATTN: Mariah McMinn PHONE NO : 843 8344689
620 Alpha Drive, Suite 2 SE DECISION MADE: 06-OCT-23
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGEL™ 3DR Anterior Cervical Corpectomy System
MiRus, LLC 510(k) NO: K232481(Traditional)
ATTN: Jordan Bauman PHONE NO : 404 3458235
1755 West Oak Parkway Suite 100 SE DECISION MADE: 13-OCT-23
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KeyLift™ Expandable Interlaminar Stabilization System
FloSpine 510(k) NO: K232484(Traditional)
ATTN: Peter Harris PHONE NO : 561 7053080
3651 FAU Blvd., Suite 400 SE DECISION MADE: 19-OCT-23
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor
Medos International SARL 510(k) NO: K232492(Traditional)
ATTN: Elizabeth P. Messana PHONE NO : 508 8283150
Chemin-Blanc 38, Case Postale SE DECISION MADE: 06-OCT-23
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
Shenzhen Lescolton Electrical Appl510(k) NO: K232499(Traditional)
ATTN: Chen Zhikui PHONE NO : 86 135 30009850
Room 301, Building 04, No. A3, FouSE DECISION MADE: 11-OCT-23
Shenzhen CN 518105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumify Diagnostic Ultrasound System
Philips Ultrasound 510(k) NO: K232500(Traditional)
ATTN: Sudipta Chakrabarti PHONE NO : 203___ 2136862
22100 Bothell Everett Hwy SE DECISION MADE: 26-OCT-23
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calibrate CCX Interbody System
Alphatec Spine, Inc. 510(k) NO: K232504(Traditional)
ATTN: Neha Mohindroo PHONE NO : 1 760 3566596
1950 Camino Vida Roble SE DECISION MADE: 13-OCT-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Perfuze Ltd. 510(k) NO: K232524(Traditional)
ATTN: Anne-Marie Gannon PHONE NO : 353 91 428083
Unit 6, Galway Business Park DangaSE DECISION MADE: 18-OCT-23
Galway IE H91 W7CP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves, Dual Color Black-Blue
Shanxi Hongjin Plastic Technology 510(k) NO: K232550(Traditional)
ATTN: Zhigang Wu PHONE NO : 86 311 66179668
Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 20-OCT-23
Linfen CN 042300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TuxDeluxe (Size 1 6100B, Size 2 6101B)
Tuxedo Imaging LLC 510(k) NO: K232552(Abbreviated)
ATTN: Patrick Williams PHONE NO : 330___ 3825733
313 S. High St SE DECISION MADE: 20-OCT-23
Akron OH 44308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ripley Spinal Screw System by SAGICO
Sagico VA USA, Llc 510(k) NO: K232561(Traditional)
ATTN: James Gibson, PhD, CPA PHONE NO : 813 8150613
2189 W Busch Blvd SE DECISION MADE: 23-OCT-23
Tampa FL 33612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steerant™ Super Stiff Guidewire
Medtronic Vascular 510(k) NO: K232570(Traditional)
ATTN: Amy Sanders PHONE NO : 859 8065300
3850 Brickway Blvd. SE DECISION MADE: 24-OCT-23
Santa Rosa CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASSALLO GT Crossing14
Filmec Co. Ltd. 510(k) NO: K232574(Special)
ATTN: Toshiya Osawa PHONE NO : 81 527 681212
1703 Wakita-cho, Moriyama-ku SE DECISION MADE: 11-OCT-23
Hagoya-shi JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASSALLO GT 018 G12; VASSALLO GT 018 G30
Filmec Co. Ltd. 510(k) NO: K232578(Special)
ATTN: Toshiya Osawa PHONE NO : 81 527 681212
1703 Wakita-cho, Moriyama-ku SE DECISION MADE: 11-OCT-23
Hagoya-shi JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
Vein 360 LLC 510(k) NO: K232584(Traditional)
ATTN: Suzanne Meyer PHONE NO : 513 5541300
4460 Lake Forest Dr Suite 230 SE DECISION MADE: 24-OCT-23
Blue Ash OH 45242-3741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K&J Consulting Corp. 510(k) NO: K232586(Traditional)
ATTN: Jeena Mathai PHONE NO : 716 7655551
2260 Glenview Dr, SE DECISION MADE: 24-OCT-23
Lansdale PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aurora Surgiscope System
Rebound Therapeutics Corporation 510(k) NO: K232618(Traditional)
ATTN: Timothy Connors PHONE NO : 609 3257161
13900 Alton Parkway, Suite 120 SE DECISION MADE: 27-OCT-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilteredFlo Warming Blankets
IOB Medical Inc 510(k) NO: K232638(Third Party - Traditional)
ATTN: Jonathan Kovach PHONE NO : 513 3265295___
504E Diamond Ave. SE DECISION MADE: 24-OCT-23
Gaithersburg MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OR3O Dual Mobility Liners
Smith & Nephew, Inc. 510(k) NO: K232667(Traditional)
ATTN: Madison Padgett PHONE NO : 901 4568789
7135 Goodlett Farms Division SE DECISION MADE: 27-OCT-23
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heating Tens, FT-615
Hivox Biotek Inc. 510(k) NO: K232675(Special)
ATTN: Leslie Peng PHONE NO : 886 2 85112668 401
5F., No. 123, Xingde Rd., SanchongSE DECISION MADE: 05-OCT-23
New Taipei City TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Knotilus+ PEEK Knotless Anchor
Stryker Endoscopy 510(k) NO: K232683(Traditional)
ATTN: Madison Mutchler PHONE NO : 408 7542000
5900 Optical Ct. SE DECISION MADE: 24-OCT-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarius Ultrasound Scanner
Clarius Mobile Health Corp. 510(k) NO: K232704(Special)
ATTN: Agatha Szeliga PHONE NO : 416 7071707
205-2980 Virtual Way SE DECISION MADE: 05-OCT-23
Vancouver CA V5M 4X3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMI Panorama
Shanghai United Imaging Healthcare510(k) NO: K232712(Special)
ATTN: Xin Gao PHONE NO : 86 021 6707688
No. 2258 Chengbei Rd. Jiading DistSE DECISION MADE: 03-OCT-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: endo.digital Platform
DreaMed Diabetes Ltd 510(k) NO: K232722(Special)
ATTN: Eran Atlas PHONE NO : 972 52 3166684
14 Kaplan St, POB 3271 SE DECISION MADE: 03-OCT-23
Petah Tikva IL 4952701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase-Triage
Aidoc Medical, Ltd. 510(k) NO: K232751(Traditional)
ATTN: Amalia Schreier PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 30-OCT-23
Tel Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex FiberTape and TigerTape Cerclage Sutures
Arthrex Inc. 510(k) NO: K232755(Special)
ATTN: Ruth Segall PHONE NO : 1 239 5984302 71764
1370 Creekside Boulevard SE DECISION MADE: 06-OCT-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swoop® Portable MR Imaging System®
Hyperfine, Inc. 510(k) NO: K232760(Special)
ATTN: Christine Kupchick PHONE NO : 203 3433404
351 New Whitfield Street SE DECISION MADE: 06-OCT-23
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: dS Breast Coil 7ch 1.5T
Invivo Corporation (Business Trade510(k) NO: K232762(Third Party - Special)
ATTN: Liselotte Kornmann PHONE NO : 31 6_____ 11621238__
3545 SW 47th Ave. SE DECISION MADE: 03-OCT-23
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Electrode Handpieces (VCT, RFTV, BMDT series)
RF Medical Co., Ltd 510(k) NO: K232763(Special)
ATTN: Kwang S Choi PHONE NO : 82 2 21084200
#502, 503, 505, 506, 507, 511, 254SE DECISION MADE: 04-OCT-23
Seoul KR 08513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nautilus VF ECMO Oxygenator
MC3 Inc. 510(k) NO: K232767(Special)
ATTN: Martha Rumford PHONE NO : 734 9959089
2555 Bishop Circle West SE DECISION MADE: 04-OCT-23
Dexter MI 48130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ID NOW Influenza A & B 2
Abbott Diagnostics Scarborough, In510(k) NO: K232775(Special)
ATTN: Jessica Stahle PHONE NO : 207 7306353
10 Southgate Road SE DECISION MADE: 10-OCT-23
Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScanNav Anatomy Peripheral Nerve Block
Intelligent Ultrasound Limited 510(k) NO: K232787(Special)
ATTN: Bhaskar Chikkanna PHONE NO : 447 850 181488
Floor 6a, Hodge House, 114-116 St SE DECISION MADE: 06-OCT-23
Cardiff GB CF101DY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TMINI™ Miniature Robotic System
Think Surgical, Inc. 510(k) NO: K232802(Special)
ATTN: Anand Patel PHONE NO : 443 7569392
47201 Lakeview Blvd. SE DECISION MADE: 12-OCT-23
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cross Vascular RF Generator and Footswitch (optional accessory)
Cross Vascular Inc. 510(k) NO: K232809(Third Party - Traditional)
ATTN: Jennifer Willner PHONE NO : 612 2408904___
535 Stevens Ave West SE DECISION MADE: 12-OCT-23
Solana Beach CA 92075 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
GBS Commonwealth Co., Ltd. 510(k) NO: K232822(Special)
ATTN: Jimmy Kim PHONE NO : 82 2 69254469
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 13-OCT-23
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monkey RingsTM External Fixation System
Paragon 28, Inc. 510(k) NO: K232838(Special)
ATTN: Edward Wells-Spicer PHONE NO : 720 9945481
14445 Grasslands Drive SE DECISION MADE: 12-OCT-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The IQoolTM System
BrainCool AB 510(k) NO: K232844(Special)
ATTN: Martin Waleij PHONE NO : 46 07333 937076
Medicon Village Scheelevagen 2 SE DECISION MADE: 04-OCT-23
Lund SE 223 81 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
Cross Vascular Inc. 510(k) NO: K232852(Third Party - Traditional)
ATTN: Jennifer Willner PHONE NO : 612 2408904___
535 Stevens Ave West SE DECISION MADE: 12-OCT-23
Solana Beach CA 92075 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TransLoc 3D
Foundation Fusion Solutions, LLC (510(k) NO: K232878(Special)
ATTN: Robert Compton PHONE NO : 888 7438736
11916 S. Oxford Ave., Suite 206 SE DECISION MADE: 17-OCT-23
Tulsa OK 74137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Small External Fixation System
Arthrex Inc 510(k) NO: K232897(Special)
ATTN: Jessica Kim PHONE NO : 1 239 6435553 73892
1370 Creekside Boulevard SE DECISION MADE: 18-OCT-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Legend X Platform
Pollogen Ltd 510(k) NO: K232903(Third Party - Traditional)
ATTN: Karen Smith PHONE NO : 650 2796242
6 Kaufman Street SE DECISION MADE: 17-OCT-23
Tel Aviv IL 68012 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Medline UNITE® REFLEX® Nitinol Staple Kit
Medline Industries, LP 510(k) NO: K232905(Special)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 19-OCT-23
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CombiDiagnost R90
Philips Medical Systems DMC GmbH 510(k) NO: K232910(Special)
ATTN: Ming Xiao PHONE NO : 49 40 349712306
Röntgenstrasse 24 SE DECISION MADE: 19-OCT-23
Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
STERIS Corporation 510(k) NO: K232914(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 03-OCT-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: enspire 300 Series Automated Endoscope Reprocessor
Steris Corporation 510(k) NO: K232918(Special)
ATTN: Nalepka Jennifer PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 03-OCT-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pure-Vu EVS System
Motus GI Medical Technologies Ltd.510(k) NO: K232922(Special)
ATTN: Mark Pomeranz PHONE NO : 908 7458599
22 Keren Ha'yesod Str. SE DECISION MADE: 20-OCT-23
Tirat Carmel IL 3902638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-Line® Hernia Mesh
Deep Blue Medical Advances, Inc. 510(k) NO: K232924(Special)
ATTN: William Perry PHONE NO : 408 2429323
701 West Main Street, Suite 410 SE DECISION MADE: 18-OCT-23
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
Steris 510(k) NO: K232951(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Rd SE DECISION MADE: 20-OCT-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synq Software Version 1.3
Synaptive Medical Inc. 510(k) NO: K232981(Third Party - Traditional)
ATTN: Ahmed Hamed PHONE NO : 1 647 2433334___
555 Richmond Street West, Suite 80SE DECISION MADE: 11-OCT-23
Toronto CA M5V 3B1 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Montage- XT Settable, Resorbable Hemostatic Bone Putty
Orthocon, Inc. 510(k) NO: K232998(Special)
ATTN: Howard Schrayer PHONE NO : 609 2737350
700 Fairfield Ave. - Suite 1 SE DECISION MADE: 12-OCT-23
Stamford CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tandem Mobi insulin pump with interoperable technology
Tandem Diabetes Care Inc. 510(k) NO: K233044(Special)
ATTN: Louise Focht PHONE NO : 1 858 2556363
12400 High Bluff Drive SE DECISION MADE: 05-OCT-23
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-PRO maX 2 Low Temperature Sterilization System
Steris 510(k) NO: K233065(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 20-OCT-23
Mentor MA 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA AGAIN PRO family
El. En. S.p.A. 510(k) NO: K233090(Special)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 27-OCT-23
Calenzano IT 50141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
Qura S.r.l. 510(k) NO: K233091(Special)
ATTN: Raffaella Tommasini PHONE NO : 39 053 51803050__
Via di Mezzo, 23 SE DECISION MADE: 26-OCT-23
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Balanced Knee® System TriMax PS Plus Tibial Insert
Ortho Development Corporation 510(k) NO: K233093(Special)
ATTN: Drew Weaver PHONE NO : 801 5539991
12187 S. Business Park Drive SE DECISION MADE: 25-OCT-23
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luja Coude (20108 Male CH18 - large packaging)
Coloplast Corp 510(k) NO: K233101(Special)
ATTN: Troy Thome PHONE NO : 612 3569917
1601 West River Road North SE DECISION MADE: 26-OCT-23
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
STARmed Co., Ltd. 510(k) NO: K233113(Special)
ATTN: Honggeun Lee PHONE NO : 82 70 467386
B-dong, 4F,12F, 158, Haneulmaeul-rSE DECISION MADE: 25-OCT-23
Goyang-si KR 10355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PiXel8-RF
Rohrer Aesthetics 510(k) NO: K233147(Special)
ATTN: Mark Rohrer PHONE NO : 205 9402200
105 Citation Court SE DECISION MADE: 25-OCT-23
Homewood AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
AtriCure, Inc. 510(k) NO: K233170(Special)
ATTN: Erica Schwab PHONE NO : 513 3749923___
7555 Innovation Way SE DECISION MADE: 26-OCT-23
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System
C2DX, Inc. 510(k) NO: K233185(Special)
ATTN: Brad Beale PHONE NO : 901 2160012
555 E Eliza St SE DECISION MADE: 24-OCT-23
Schoolcraft MI 49087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
Steris 510(k) NO: K233187(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 27-OCT-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polaris X™ Unidirectional Steerable Diagnostic Catheter
Boston Scientific Corporation 510(k) NO: K233207(Special)
ATTN: Amy Reilly PHONE NO : 651 5824805___
4100 Hamline Avenue North SE DECISION MADE: 27-OCT-23
St. Paul MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: sam CS Long Duration Ultrasound Device
ZetrOZ Systems, LLC 510(k) NO: K233210(Special)
ATTN: Sabrina Lewis PHONE NO :
56 Quarry Road SE DECISION MADE: 25-OCT-23
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)
SenoRx, Inc. 510(k) NO: K233220(Special)
ATTN: Kathryn Swanstrom PHONE NO : 602 8305623___
1625 West 3rd Street SE DECISION MADE: 27-OCT-23
Tempe AZ 85251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OGmend® Implant Enhancement System
Woven Orthopedic Technologies 510(k) NO: K233223(Special)
ATTN: Brandon Bendes PHONE NO : 860 2591262
63 E Center St, #3a SE DECISION MADE: 26-OCT-23
Manchester CT 06040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPHASYS Femoral Stems
DePuy Ireland UC 510(k) NO: K233233(Special)
ATTN: Sarah Matamisa PHONE NO : 44 7876 217532
Loughbeg Ringaskiddy SE DECISION MADE: 11-OCT-23
Co. Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PressON Spinal Fixation System
Nexus Spine, LLC 510(k) NO: K233234(Special)
ATTN: Jared Crocker PHONE NO : 801 7028592
2825 East Cottonwood Parkway SuiteSE DECISION MADE: 26-OCT-23
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLACE Sacroiliac Fixation System
HT Medical LLC dba Xenix Medical 510(k) NO: K233241(Special)
ATTN: Teresa Cherry PHONE NO : 407 7854216
111 W Jefferson St Suite 100 SE DECISION MADE: 27-OCT-23
Orlando FL 32801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shadow Knotless All-Suture Anchors
Responsive Arthroscopy LLC 510(k) NO: K233258(Special)
ATTN: Garrett Ahlborg PHONE NO : 612 5326800___
701 N 3rd Street, Suite 208 SE DECISION MADE: 23-OCT-23
Minneapolis MN 55401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuNav Crystal Ultrasound Catheter
Siemens Medical Solutions USA, Inc510(k) NO: K233270(Special)
ATTN: Bongsoo Cho PHONE NO : 425 6069346
22010 S.E. 51st Street SE DECISION MADE: 28-OCT-23
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
inomed Medizintechnik GmbH 510(k) NO: K233292(Special)
ATTN: Tomasz Moszkowski PHONE NO : 49 7641 9414583
Im Hausgruen 29 SE DECISION MADE: 27-OCT-23
Emmendingen DE 79312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)
Boston Scientific Corporation 510(k) NO: K233318(Special)
ATTN: Mr. Ian Broome PHONE NO : 1 339 2130691
100 Boston Scientific Way SE DECISION MADE: 27-OCT-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINQ II™ Insertable Cardiac Monitor (LNQ22)
Medtronic, Inc. 510(k) NO: K233320(Special)
ATTN: Dustin Hawbaker PHONE NO : 763 5263906
Cardiovascular Diagnostics and SerSE DECISION MADE: 31-OCT-23
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 16 Breast Coil
Philips Medical System Nederlands 510(k) NO: K233348(Special)
ATTN: Shruti Sancheti PHONE NO : 91 95 18546814
Veenpluis 6 SE DECISION MADE: 24-OCT-23
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AllTest Fentanyl Urine Test Cassette
Hangzhou AllTest Biotech Co.,Ltd 510(k) NO: K233417(Traditional)
ATTN: Rosa Wu PHONE NO : 86 571 5812061
#550, Yinhai Street SE DECISION MADE: 26-OCT-23
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 309
TOTAL WITH SUMMARIES 296
TOTAL WITH STATEMENTS 13
