510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2022
DEVICE: Medidenta High Speed Handpieces
Pac-Dent, Inc. 510(k) NO: K202674(Traditional)
ATTN: Jiahe Li PHONE NO : 909 8390888
670 Endeavor Circle SE DECISION MADE: 12-DEC-22
Brea CA 92821 510(k) STATEMENT
DEVICE: CURA-Temp
Mgnewton LTD. 510(k) NO: K202965(Traditional)
ATTN: Byoung Wook Ahn PHONE NO : 82 53 2146287
472, Hanjanggun-ro, Jain-myeon SE DECISION MADE: 21-DEC-22
Gyeongsan-si KR 38552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTOnco, ACTOnco IVD
ACT Genomics 510(k) NO: K210017(Traditional)
ATTN: Pei-Fang Chung PHONE NO : 886 2 27953660 1303
3F, No 345, Xinhu 2nd Road., NeihuSE DECISION MADE: 23-DEC-22
Taipei TW 11494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
Shanghai MicroPort EP MedTech Co.,510(k) NO: K210313(Traditional)
ATTN: Xia Tian PHONE NO : 86 21 38954600 3613
Building 23&28, Lane 588, TianxionSE DECISION MADE: 30-DEC-22
Shanghai CN 201318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lp(a) Ultra
Sentinel CH. SpA 510(k) NO: K211058(Traditional)
ATTN: Patricia Dupé PHONE NO : 39 023 4551496
Via Robert Koch 2 SE DECISION MADE: 22-DEC-22
Milan IT 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STA- NeoPTimal
Diagnostica Stago SAS 510(k) NO: K211485(Traditional)
ATTN: Pauline Vasselon PHONE NO : 33 146 882378
3 allée Thérésa SE DECISION MADE: 23-DEC-22
Asniéres sur Seine FR 92600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoPATx
Itamar Medical, Ltd. 510(k) NO: K211557(Traditional)
ATTN: Moti Mikles PHONE NO : 972 4617 7000
9 Halamish Street SE DECISION MADE: 29-DEC-22
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-Parameter Patient Monitor
Shenzhen Comen Medical Instruments510(k) NO: K211619(Traditional)
ATTN: Hongbo Yan PHONE NO : 86 134 24152596
FIYTA Timepiece Building, Nanhuan SE DECISION MADE: 29-DEC-22
Shenzhen CN 51806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
Quality in Flow Ltd. 510(k) NO: K211800(Traditional)
ATTN: Omer Pechter PHONE NO : 9 725 06492360
11 Ha’avoda st. SE DECISION MADE: 08-DEC-22
Rosh Ha’ayin IL 4801761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
CEFALY Technology 510(k) NO: K212071(Traditional)
ATTN: Rufus Kay Moberly PHONE NO : 716 6228077
Rue Louis Plescia 34 SE DECISION MADE: 13-DEC-22
Seraing BE 4102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENOVIEW 3.0T Chest Coil
Polarean, Inc. 510(k) NO: K212239(Traditional)
ATTN: Neil Wadehra PHONE NO : 919 2067900
PO Box 14805 SE DECISION MADE: 23-DEC-22
Research Triangle Park NC 27709-4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardioPhase® hsCRP
Siemens Healthcare Diagnostics Pro510(k) NO: K212559(Special)
ATTN: Martina Pfeiff PHONE NO : 49 174 3319336
Emil-von-Behring Str. 76 SE DECISION MADE: 16-DEC-22
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVC Hydrophilic Urethral Catheter
Chengdu Daxan Innovative Medical T510(k) NO: K212567(Traditional)
ATTN: Kevin Huang PHONE NO : 86 760 22819569
Unit 6, Building 1, No.18, North BSE DECISION MADE: 07-DEC-22
Chengdu CN 611135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: truSculpt flex
Johari Digital Healthcare Limited 510(k) NO: K212866(Traditional)
ATTN: Pooja Johari PHONE NO : 1 818 5218947
G-582, 584 EPIP, Boranda SE DECISION MADE: 03-DEC-22
Jodhpur IN 342012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioButton System
BiolntelliSense Inc. 510(k) NO: K212957(Traditional)
ATTN: Yusi Liu PHONE NO : 703 7760119
570 El Camino Real, Suite 200 SE DECISION MADE: 12-DEC-22
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Medline Industries, Inc. 510(k) NO: K213054(Traditional)
ATTN: Dinah Rincones PHONE NO : 847 9792687
Three Lakes Drive SE DECISION MADE: 09-DEC-22
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epilaser Absolute
Epilady 2000 LLC 510(k) NO: K213105(Traditional)
ATTN: Moshe Rosenthal PHONE NO : 972 468 60400
3 Hacharash St. Ind. Zone SE DECISION MADE: 13-DEC-22
Hazor Haglilit IL 1035102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
Auxein Medical Private Limited 510(k) NO: K213110(Traditional)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 16-DEC-22
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BPAP System
BMC Medical Co., Ltd. 510(k) NO: K213169(Traditional)
ATTN: Fang Zheng PHONE NO : 86 105 1663880
Room 901, Building 1, No. 28 PinggSE DECISION MADE: 05-DEC-22
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARVEL™ Growing Rods
Globus Medical Inc. 510(k) NO: K213196(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 19-DEC-22
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxygen Concentrator, Model JAY-5AW
LONGFIAN SCITECH CO., LTD. 510(k) NO: K213210(Traditional)
ATTN: Shi Lei PHONE NO : 86 312 5909505
2F&3F, East Section, Building 12, SE DECISION MADE: 08-DEC-22
Baoding CN 071051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
PENTAX of America, Inc. 510(k) NO: K213235(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 21-DEC-22
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CMFlexTM
Dimension Inx Corp. 510(k) NO: K213260(Traditional)
ATTN: Ramille Shah PHONE NO : 1 312 2353510
3440 S Dearborn St. Suite 142S SE DECISION MADE: 30-DEC-22
Chicago IL 60616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip Pulse Oximeter
Shenzhen Witleaf Medical Electroni510(k) NO: K213430(Traditional)
ATTN: Wu Tao PHONE NO : 86 755 21384132
13/F-B2, Block 1, Senyang Science SE DECISION MADE: 30-DEC-22
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardioGraphe
Arineta Ltd. 510(k) NO: K213465(Traditional)
ATTN: Tanya Shalem PHONE NO : 972 54 3407880
15 Halamish Street SE DECISION MADE: 02-DEC-22
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BiWaze Clear System
ABMRC LLC 510(k) NO: K213564(Traditional)
ATTN: Leah Noaeill PHONE NO : 1 612 4191071
860 Blue Gentian Road Suite 200 SE DECISION MADE: 21-DEC-22
Eagan MN 55121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Wuhan Zonsen Medical Products Co.,510(k) NO: K213601(Traditional)
ATTN: Cynthia Ye PHONE NO : 86 027 82737771
No 8 Jinchao Road, Zhucheng StreetSE DECISION MADE: 16-DEC-22
Wuhan CN 431000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
Solco Biomedical Company India Pri510(k) NO: K213653(Traditional)
ATTN: Darshak Shah PHONE NO : 91 982 5206091
5 & 6 Third FloorB. Jadav ChambersSE DECISION MADE: 19-DEC-22
Ahmedabad IN 380009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bonafix 2 Plus
Zentek Medical LLC 510(k) NO: K213677(Traditional)
ATTN: Michael Vinnik PHONE NO : 732 2840545
200 Craig Rd Ste 107 SE DECISION MADE: 20-DEC-22
Manalapan NJ 077268735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICE Ceramics, ICE Stains, Fresco
Zirkonzahn srl 510(k) NO: K213722(Traditional)
ATTN: Julian Steger PHONE NO : 39 0474 066660
Via An der Ahr 7 SE DECISION MADE: 14-DEC-22
Gais IT 39030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bolt Navigation System
Circinus Medical Technology, LLC 510(k) NO: K213768(Traditional)
ATTN: Patrick West PHONE NO : 207 6511334
4450 Arapahoe Avenue, Suite 1000 SE DECISION MADE: 01-DEC-22
Boulder CO 80303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI TM Tricyclics Serum Tox Assay
Microgenics Corporation 510(k) NO: K213875(Traditional)
ATTN: Pranjali Shinde PHONE NO : 213 3449952
46500 Kato Road SE DECISION MADE: 21-DEC-22
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comfort Gown, Safewear Gown
Xuchang Zhengde Environstar Medica510(k) NO: K213893(Traditional)
ATTN: Vincent Yu PHONE NO : 86 186 58510660
Area B, Baihua Road East, South SiSE DECISION MADE: 21-DEC-22
Xuchang CN 461200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G7 Continuous Glucose Monitoring System
Dexcom, Inc. 510(k) NO: K213919(Traditional)
ATTN: Neeta Sharma PHONE NO : 1 858 2036362
6340 Sequence Dr. SE DECISION MADE: 07-DEC-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
ShenZhen ZhengKang Technology Co.,510(k) NO: K213984(Traditional)
ATTN: Huayong Yang PHONE NO : 86 180 98903693
2&3/F, Building A, No. 3 FuXing YiSE DECISION MADE: 16-DEC-22
ShenZhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOcheck Chromogenic Factor IX
Precision BioLogic Inc. 510(k) NO: K214002(Traditional)
ATTN: Karen Black PHONE NO : 902 4686422 226
140 Eileen Stubbs Avenue SE DECISION MADE: 23-DEC-22
Dartmouth CA B3B 0A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CCBIO ASCPO Needle
CC Biotechnology Corporation 510(k) NO: K214004(Traditional)
ATTN: Edgar Yeh PHONE NO : 886 6 3845868
No. 68, Gongye 5th Rd., Annan DistSE DECISION MADE: 13-DEC-22
Tainan TW 709015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIEW
Coreline Soft Co.,Ltd. 510(k) NO: K214036(Traditional)
ATTN: Hyeyi Park PHONE NO : 82 257 17321
4,5F(Yeonnam-dong), 49, World Cup SE DECISION MADE: 23-DEC-22
Seoul KR 03991 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap AICON Container
Aesculap Inc. 510(k) NO: K214041(Traditional)
ATTN: Omunique (Nikki) Luke PHONE NO : 484 5236868
3773 Corporate Parkway SE DECISION MADE: 30-DEC-22
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EsCem
SPIDENT CO., LTD. 510(k) NO: K214076(Traditional)
ATTN: J.M. Ahn PHONE NO : 82 32 8210071
203 & 312, Korea Industrial CompleSE DECISION MADE: 19-DEC-22
Gojan-Dong, Namdong-Gu KR 405-821510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
Genoss Co., Ltd. 510(k) NO: K214086(Traditional)
ATTN: Woojung Park PHONE NO : 82 70 70988938
1F, Gyeonggi R&DB Center, 105 GwanSE DECISION MADE: 15-DEC-22
Suwon-si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Daylily Single Use Sterile Embryo Transfer Catheter
Shanghai Horizon Medical Technolog510(k) NO: K220010(Traditional)
ATTN: Beibei Xing PHONE NO : 86 021 38954600
Room 401, Building #24, No. 1-28, SE DECISION MADE: 16-DEC-22
Shanghai CN 201318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BresoDX1
Bresotec Inc 510(k) NO: K220012(Traditional)
ATTN: Esther Sur PHONE NO : 1 647 8084221
55 York Street Unit 200 SE DECISION MADE: 21-DEC-22
Toronto CA M5J 1R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wellead Ureteral Catheter
Well Lead Medical Co., Ltd. 510(k) NO: K220036(Traditional)
ATTN: Jenny Zhu PHONE NO : 86 20 84758878
No.47, Guomao Avenue South, HualonSE DECISION MADE: 16-DEC-22
Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
Shenzhen Superbio Technology Co.,L510(k) NO: K220046(Traditional)
ATTN: Wenhau Yan PHONE NO : 86 755 2741729
Building B, Xinzheng, 71 Area, XinSE DECISION MADE: 13-DEC-22
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Copan FecalSwab Collection, Transport and Preservation System
Copan Italia S.p.A. 510(k) NO: K220052(Traditional)
ATTN: Elisabetta Zanella PHONE NO : 39 030 2687211
via F. Perotti 10 SE DECISION MADE: 16-DEC-22
Brescia IT 25125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magicore Narrow System
InnoBioSurg Co., Ltd. 510(k) NO: K220079(Traditional)
ATTN: Ga Yun Kim PHONE NO : 84 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 14-DEC-22
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: multiFiltratePRO System
Fresenius Medical Care Renal Thera510(k) NO: K220281(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 16-DEC-22
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROCYN soma
V3bio Sdn. Bhd 510(k) NO: K220286(Traditional)
ATTN: Shudipta Choudhury PHONE NO : 4 588 6993
No 18 Jalan Cassia Selatan 3/1 TamSE DECISION MADE: 21-DEC-22
Simpang Ampat MY 14100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CreoDent Solidex Customized Abutment and Screw
CreoDent Prosthetics, Ltd. 510(k) NO: K220390(Traditional)
ATTN: Calvin Shim PHONE NO : 212 3023860
29 West 30th Street, 11th Floor SE DECISION MADE: 02-DEC-22
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBS System
InnoBioSurg Co., Ltd. 510(k) NO: K220517(Traditional)
ATTN: Ga Yun Kim PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 20-DEC-22
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PM Excellence SEQUR 100 Surgical Face Mask
PM Excellence LLC 510(k) NO: K220520(Traditional)
ATTN: Nina Bektic-Marrero PHONE NO : 917 6407980
2864 Wilson Avenue SE DECISION MADE: 15-DEC-22
Bellmore NY 11710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caduceus S
Taiwan Main Orthopaedic Biotechnol510(k) NO: K220554(Traditional)
ATTN: Jacky Fan PHONE NO : 886 4 37073159 213
1F., No. 46, Keya Rd., Daya Dist. SE DECISION MADE: 16-DEC-22
Taichung City TW 428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Proxima
Dynasthetics LLC 510(k) NO: K220591(Traditional)
ATTN: Joseph Orr PHONE NO : 801 4843820 551
3487 West 2100 South #300 SE DECISION MADE: 15-DEC-22
Salt Lake City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUREcore Plus Biopsy Instrument
Uro-1, Inc. 510(k) NO: K220611(Traditional)
ATTN: Thomas Lawson PHONE NO : 336 9305464
3701-A Alliance Drive SE DECISION MADE: 02-DEC-22
Greensboro NC 27407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sleeved IC
Hollister Incorporated 510(k) NO: K220667(Traditional)
ATTN: Sandra Mullen PHONE NO : 353 86 3011706
2000 Hollister Drive SE DECISION MADE: 08-DEC-22
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SilentZPro 2.0
Shinrin-Yoku Traders LLC 510(k) NO: K220688(Traditional)
ATTN: Ryan Bruss PHONE NO : 1 971 7129175
18450 SW Seiffert Rd SE DECISION MADE: 02-DEC-22
Sherwood OR 97140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroMID 4F Single Lumen Midline Catheter
Access Vascular, Inc. 510(k) NO: K220772(Traditional)
ATTN: Brian M. Hanley PHONE NO : 781 5386594 101
749 Middlesex Turnpike SE DECISION MADE: 07-DEC-22
Billirica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RobPath® Total Hip Application
Hangzhou Lancet Robotics Co., Ltd.510(k) NO: K220774(Traditional)
ATTN: Rennes Zhang PHONE NO : 86 571 86268173
508, 5th Floor, Building 4, No. 5,SE DECISION MADE: 09-DEC-22
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chemical Indicator for Steam
True Indicating LLC 510(k) NO: K220778(Traditional)
ATTN: Thomas Riha PHONE NO : 248 9826492
946 Kane St SE DECISION MADE: 02-DEC-22
Toledo OH 43612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAR Apollo Mapping System
Rhythm Al, Ltd 510(k) NO: K220786(Traditional)
ATTN: Linda D'Abate PHONE NO : 714 2356608
Office G2, Whitney Business and InSE DECISION MADE: 01-DEC-22
Witney GB OX 29 7DX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D-SHAPER
3D-Shaper Medical S.L 510(k) NO: K220822(Traditional)
ATTN: Ludovic Humbert PHONE NO : 34 93 3283964
C/ Paris 179, 2-2 SE DECISION MADE: 09-DEC-22
Barcelona ES 08036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Curing Light
Foshan COXO Medical Instrument Co.510(k) NO: K220826(Traditional)
ATTN: Yongjian Zheng PHONE NO : 86 137 02544788
BLDG 4, District A, Guangdong New SE DECISION MADE: 08-DEC-22
Nanhai District, Foshan CN 528226510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OAKTREE Anterior Lumbar Plate and Screw System
Oak Tree Engineering, LLC. 510(k) NO: K220843(Traditional)
ATTN: Douglas W. Neary PHONE NO : 805 7973003
419 Main Street, #242 SE DECISION MADE: 07-DEC-22
Huntington Beach CA 92648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perceptive electric dental motor and control unit
Lares Research 510(k) NO: K220873(Traditional)
ATTN: Bruce Holderbein PHONE NO : 530 3451767 2862
295 Lockheed Ave SE DECISION MADE: 15-DEC-22
Chico CA 95973 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOUE BALLOON A
Toray Industries, Inc. 510(k) NO: K220881(Traditional)
ATTN: Satoshi Kakuyama PHONE NO : 81 3 32458606
1-1, Nihombashi-Muromachi 2-Chome SE DECISION MADE: 18-DEC-22
Chuo-ku JP 103-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Small Field Applicator
Hitachi, Ltd. Radiation Oncology S510(k) NO: K220883(Traditional)
ATTN: Tomoyuki Seino PHONE NO : 81 294 555232
226-44-141-1, Wakashiba SE DECISION MADE: 15-DEC-22
Kashiwa-shi JP 277-0871 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Metal Bone Screw
Double Medical Technology Inc. 510(k) NO: K220921(Traditional)
ATTN: Yan Zuo PHONE NO : 86 592 6885068
No.18, Shanbianhong East Road, HaiSE DECISION MADE: 12-DEC-22
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectra Wearable
Uzinmedicare Co., Ltd. 510(k) NO: K220926(Traditional)
ATTN: Jisun Lee PHONE NO : 82 10 63447017
56, Dongtansandan 5-Gil SE DECISION MADE: 12-DEC-22
Hwaseong-Si KR 18487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Overjet Calculus Assist
Overjet Inc. 510(k) NO: K220928(Traditional)
ATTN: Adam Odeh PHONE NO : 817 9887697___
560 Harrison Ave., Unit 403 SE DECISION MADE: 16-DEC-22
Boston MA 02118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
liberDi, Ltd 510(k) NO: K220935(Traditional)
ATTN: Hezkiah Tsoory PHONE NO : 972 54 6200722
14 Hallan Street SE DECISION MADE: 29-DEC-22
Or Aquiva IL 510(k) STATEMENT
DEVICE: PMT Facet Fixation System (PMT FFS)
Providence Medical Technology, Inc510(k) NO: K220951(Traditional)
ATTN: Edward Liou PHONE NO : 415 3148593
4234 Hacienda Drive, Suite 150 SE DECISION MADE: 09-DEC-22
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuikClot Control+ Hemostatic Dressing
Z-Medica, LLC 510(k) NO: K220971(Traditional)
ATTN: Soraya King PHONE NO : 203 9806067
4 Fairfield Boulevard SE DECISION MADE: 14-DEC-22
Wallingford CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R:GEN
Lutronic Vision, Inc. 510(k) NO: K220974(Traditional)
ATTN: Haelyung Hwang PHONE NO : 888 5887644
19 Fortune Drive SE DECISION MADE: 27-DEC-22
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliSep test
Cytovale Inc. 510(k) NO: K220991(Traditional)
ATTN: Juliet Carrara PHONE NO : 530 9020989
150 Executive Park Blvd, Suite 410SE DECISION MADE: 20-DEC-22
San Francisco CA 94134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOPKINS Telescopes
KARL STORZ Endoscopy America, Inc.510(k) NO: K221004(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
2151 E. Grand Ave SE DECISION MADE: 20-DEC-22
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI.ME System
Venus Concept USA Inc. 510(k) NO: K221011(Traditional)
ATTN: William H McGrail PHONE NO : 978 8080420
1880 N Commerce Pkwy, Suite 2 SE DECISION MADE: 20-DEC-22
Weston FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Femoral Trochanteric Nail System – Neonail
Neoortho Produtos Ortopédicos S/A 510(k) NO: K221021(Traditional)
ATTN: Luciane Suzuki PHONE NO : 55 41 35351033
Rua Ângelo Domingos Durigan, 607 ,SE DECISION MADE: 06-DEC-22
Curitiba BR 82025-100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex DualCompression Hindfoot Fusion Nail Implant System
Arthrex Inc. 510(k) NO: K221031(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 5984302 73429
1370 Creekside Boulevard SE DECISION MADE: 20-DEC-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
Shenzhen AOJ Medical Technology Co510(k) NO: K221039(Traditional)
ATTN: Jack Wang PHONE NO : 86 755 27786026
Room 301&4F, Blk A, Building A, JiSE DECISION MADE: 20-DEC-22
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Episealer Patellofemoral System
Episurf Medical, Inc. 510(k) NO: K221048(Traditional)
ATTN: Katarina Flodstrom PHONE NO : 686 8459447
220 E 42nd Street, Suite 409A SE DECISION MADE: 23-DEC-22
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORE-INJECTOR
Incore Co., Ltd. 510(k) NO: K221054(Traditional)
ATTN: Jae-Hun Lee PHONE NO : 82 2 8663514
11, Hyeoksin-daero, 78-gil, Dong-gSE DECISION MADE: 21-DEC-22
Daegu KR 41072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DP4 Microneedling device
Equipmed USA LLC 510(k) NO: K221070(Traditional)
ATTN: Shaun Kerrigan PHONE NO : 949 7986111
Suite 1100, 4695 Macarthur Court SE DECISION MADE: 20-DEC-22
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOTUS Series 4 Enhanced Shears, LOTUS Series 5
SRA Developments Ltd 510(k) NO: K221102(Traditional)
ATTN: Phillipa Frewin PHONE NO : 44 0 1364652426
Bremridge House SE DECISION MADE: 15-DEC-22
Ashburton GB TQ13 7JX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
Shenzhen Mindray Bio-Medical Elect510(k) NO: K221113(Traditional)
ATTN: Li Lei PHONE NO : 86 755 81885953
Mindray Building, Keji 12th Road SSE DECISION MADE: 02-DEC-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PageWriter TC35 Cardiograph
Medizin Systeme Boblingen GmbH 510(k) NO: K221141(Traditional)
ATTN: Judy Yang PHONE NO : 86 136 36493274__
Hewlett-Packard Strasse 2 SE DECISION MADE: 02-DEC-22
Boblingen DE 71032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Southern Transforaminal Lumbar Interbody Fusion (TLIF)
Southern Medical (Pty) Ltd 510(k) NO: K221182(Traditional)
ATTN: Dalene Styger PHONE NO : 27 12 66762434
55 Regency Drive, Route 21 CorporaSE DECISION MADE: 08-DEC-22
Irene ZA 0178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
OSSIO Ltd. 510(k) NO: K221193(Traditional)
ATTN: Taly Lindner PHONE NO : 972 4 9986600 214
8 HaTochen Street SE DECISION MADE: 23-DEC-22
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Intramedullary Nail System
Double Medical Technology Inc. 510(k) NO: K221221(Traditional)
ATTN: Yan Zuo PHONE NO : 86 592 6885079
No.18, Shanbianhong East Road, HaiSE DECISION MADE: 21-DEC-22
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd. 510(k) NO: K221245(Traditional)
ATTN: Ron Lv PHONE NO : 86 150 51429102
BLDG 6, No. 8, Jinfeng Road SE DECISION MADE: 14-DEC-22
Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
Shenzhen Mindray Bio-Meidcal Elect510(k) NO: K221267(Traditional)
ATTN: Li Lei PHONE NO : 86 755 81885953
Mindray Building, Keji 12th Road SSE DECISION MADE: 15-DEC-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vesseal
Lydus Medical Ltd. 510(k) NO: K221280(Traditional)
ATTN: Jessica Weiss PHONE NO : 972 54 9001433
13 Zarhin St. SE DECISION MADE: 09-DEC-22
Ra'anana IL 4366241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HVT 2.0
Vapotherm Inc. 510(k) NO: K221318(Traditional)
ATTN: Michael J. Webb PHONE NO : 978 3147212
100 Domain Drive SE DECISION MADE: 13-DEC-22
Exeter NH 03833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
Acumed LLC 510(k) NO: K221333(Traditional)
ATTN: Saleh Amirriyazi PHONE NO : 925 3537073
5885 NE Cornelius Pass Rd. SE DECISION MADE: 29-DEC-22
Hillsboro OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDEMPTION Beaming System
Vilex, LLC 510(k) NO: K221342(Traditional)
ATTN: Louis Monaco PHONE NO : 435 6591880
111 Moffitt St. SE DECISION MADE: 13-DEC-22
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: nView s1 with nav option
nView medical 510(k) NO: K221344(Traditional)
ATTN: Lisa Last PHONE NO : 617 2837053
2681 E Parleys Way STE 107 SE DECISION MADE: 28-DEC-22
Salt Lake City UT 84109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mechanical Guidewire
Baylis Medical Company Inc. 510(k) NO: K221351(Traditional)
ATTN: May Tsai PHONE NO : 905 6024875
5825 Explorer Dr. SE DECISION MADE: 19-DEC-22
Mississauga CA L4W 5P6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Immuodiagnostic Products CA 125 II Reagent Pack
Ortho Clinical Diagnostics 510(k) NO: K221355(Traditional)
ATTN: Rebecca Lewis PHONE NO : 44 07971 427649____
Felindre Meadows Pencoed SE DECISION MADE: 12-DEC-22
Bridgend GB CF35 5PZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
AtriCure, Inc 510(k) NO: K221358(Traditional)
ATTN: Jonathan McElwee PHONE NO : 513 7959127
7555 Innovation Way SE DECISION MADE: 30-DEC-22
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SteriKing LT-Blueline Pouches with Tyvek
Wipak OY 510(k) NO: K221377(Traditional)
ATTN: Hanna Marttila PHONE NO : 358 040 1240290
Wipaktie 2 SE DECISION MADE: 22-DEC-22
Nastola FI FI-15560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex FiberTak Suture Anchor
Arthrex Inc. 510(k) NO: K221396(Traditional)
ATTN: Lai Saeteurn PHONE NO : 239 5984302 71764
1370 Creekside Boulevard SE DECISION MADE: 22-DEC-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Self-Cath and Self-Cath Plus
Coloplast 510(k) NO: K221401(Traditional)
ATTN: Preeti Jain PHONE NO : 612 4135614
1601 West River Road North SE DECISION MADE: 02-DEC-22
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maestro Platform
Moon Surgical 510(k) NO: K221410(Traditional)
ATTN: Anne Osdoit PHONE NO :
c/o Sofinnova Partners, 7/11 Bd HaSE DECISION MADE: 02-DEC-22
Paris FR 75009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PerioStom Dental Dressing
Forward Science LLC 510(k) NO: K221428(Traditional)
ATTN: Brian Pikkula PHONE NO : 855 6967254
10810 Criaghead Dr SE DECISION MADE: 22-DEC-22
Houston TX 77025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Eye Perfector, model: EY-36A, EY-36B
Light Tree Ventures Europe B.V. 510(k) NO: K221444(Traditional)
ATTN: Kim Laurens PHONE NO : 86 13510 3787481
Laan van Ypenburg 108, 2497 GC SE DECISION MADE: 08-DEC-22
The Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Dental Implant System
S.I.N. – Sistema de Implante Nacio510(k) NO: K221453(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 15-DEC-22
São Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AG100s
Hospitech Respiration Ltd. 510(k) NO: K221477(Traditional)
ATTN: Yoel Bergman PHONE NO : 972 52 7570110
15 Atir Yeda SE DECISION MADE: 29-DEC-22
Kfar Saba IL 446312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dozee VS
Turtle Shell Technologies Private 510(k) NO: K221555(Traditional)
ATTN: Gaurav Parchani PHONE NO : 91 973 8044710
#40, City Centre, Ground and MezzaSE DECISION MADE: 15-DEC-22
Bengaluru IN 560038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviCam Small Bowel Capsule Endoscopy System
ANKON Technologies Co., Ltd. 510(k) NO: K221590(Traditional)
ATTN: Si Feng Wang PHONE NO : 86 27 87056201
B3-2, B3-3, D3-4 Biolake, No.666, SE DECISION MADE: 02-DEC-22
Wuhan CN 430075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wearable breast pump
Mayborn (UK) Limited 510(k) NO: K221598(Traditional)
ATTN: Sean Neasham PHONE NO : 44 191 2504509
Mayborn House Balliol Business ParSE DECISION MADE: 09-DEC-22
Newcastle Upon Tyne, GB NE12 8EW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™ ENPlus Spike Set with Flush Bag ( BSPFF);Kangaroo OMNI™ ENtelliSet ENPlus Spike with Flush Bag (ESPFF);Kangaroo OMNI™ Thick Formula ENtelliSet 500ml (E5FDR);Kangaroo OMNI™ Thick Formula ENtelliSet 500ml with Flush Bag (E5FFR);Kangaroo OMNI™ Thick Formula ENtelliSet 1000ml (E10FDR);Kangaroo OMNI™ Thick Formula ENtelliSet 1000ml with Flush Bag (E10FFR);Kangaroo OMNI™ Burette ENtelliSet (ER100);Kangaroo™ Power Cord with Adapter (384491);Kangaroo™ Adjustable Pole Clamp (384492);
Cardinal Health LLC 510(k) NO: K221603(Traditional)
ATTN: Varela Fredy PHONE NO : 847 8875781
3651 Birchwood Drive SE DECISION MADE: 20-DEC-22
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearRead CT
Riverain Technologies, Inc. 510(k) NO: K221612(Traditional)
ATTN: Jonathan Jackson PHONE NO : 937 5315092
3130 South Tech Blvd. SE DECISION MADE: 05-DEC-22
Miamisburg OH 45342-4860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
JR Engineering & Medical Technolog510(k) NO: K221626(Abbreviated)
ATTN: Ganesan Subramaniam PHONE NO : 603 60 572081
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 07-DEC-22
Hulu Selangor MY 44200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIRIUS Endoscope System
Precision Robotics (Hong Kong) Lim510(k) NO: K221642(Traditional)
ATTN: Ping Lai Benny Lo PHONE NO : 852 60638873
Suite 611-612 Lakeside 2, 10W, HonSE DECISION MADE: 12-DEC-22
Hong Kong CN 0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
Olympus Medical Systems Corp. 510(k) NO: K221660(Traditional)
ATTN: Shinichiro Kawachi PHONE NO : 81 42 6422697
2951 Ishikawa-cho SE DECISION MADE: 28-DEC-22
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IOB Warming Blankets
IOB Medical Inc 510(k) NO: K221669(Traditional)
ATTN: Jiulin Xia PHONE NO : 301 2500831
504E Diamond Ave., Suite I SE DECISION MADE: 27-DEC-22
Gaithersburg MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
Olympus Medical Systems Corp. 510(k) NO: K221690(Traditional)
ATTN: Shinichiro Kawachi PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 29-DEC-22
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eargo 5 , Eargo 6
Eargo, Inc. 510(k) NO: K221698(Traditional)
ATTN: Monica Barrett PHONE NO : 916 8495399
2665 North First Street, Suite 300SE DECISION MADE: 21-DEC-22
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIMILRE Free-T2 Plus
Cimilre Co., Ltd. 510(k) NO: K221708(Third Party - Traditional)
ATTN: Not Provided PHONE NO : 82 41 5530941
97-14 Seongnam-ro, Mokcheon-Eup, DSE DECISION MADE: 23-DEC-22
Cheonan-Si KR 31234 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Extra Silver Gelling Fiber Dressing
Winner Medical Co., Ltd. 510(k) NO: K221720(Traditional)
ATTN: Mingni Liu PHONE NO : 86 755281 38888_____ 8822
Winner Industrial Park, No. 660 BuSE DECISION MADE: 21-DEC-22
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mineral Collagen Composite Bioactive Moldable
Collagen Matrix, Inc. 510(k) NO: K221735(Traditional)
ATTN: Peggy Hansen PHONE NO : 201 4051477
15 Thornton Road SE DECISION MADE: 20-DEC-22
Oakland NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
Fitone Latex Products Co., Ltd. Gu510(k) NO: K221747(Traditional)
ATTN: Christine Ou PHONE NO : 0759 7905808
No.5 Huitong road, Lingbei IndustrSE DECISION MADE: 01-DEC-22
Zhanjiang CN 524338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE DAT Benzodiazepines II
Roche Diagnostics 510(k) NO: K221765(Traditional)
ATTN: Khoa Tran PHONE NO : 317 7275001
9115 Hague Road SE DECISION MADE: 23-DEC-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
Light Tree Ventures Europe B.V. 510(k) NO: K221775(Traditional)
ATTN: Kim Laurens PHONE NO : 86 755 25024651
Laan van Ypenburg 108, 2497 GC SE DECISION MADE: 20-DEC-22
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProBeam 360° Proton Therapy System
Varian Medical Systems, Inc. 510(k) NO: K221791(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4245728
3100 Hansen Way SE DECISION MADE: 01-DEC-22
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cyware 4H and Cysart 4H
Abys Medical 510(k) NO: K221796(Traditional)
ATTN: Arnaud Destainville PHONE NO : 33 6 63514775
40 Rue Chef De Baie SE DECISION MADE: 30-DEC-22
La Rochelle FR 17000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer (Model: Y20001, Y20002)
Zhangzhou Easepal Medical Science 510(k) NO: K221800(Traditional)
ATTN: Flower Flower PHONE NO : 86 1890 5963518
West of the 4th Floor, No. 7 BuilSE DECISION MADE: 14-DEC-22
Zhangzhou CN 0596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruLift Lateral Expandable Spacer System & Lateral Plate System
Life Spine Inc. 510(k) NO: K221806(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 05-DEC-22
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
Becton Dickinson, and Company 510(k) NO: K221826(Traditional)
ATTN: Kamisha Gray PHONE NO : 336 3500948
7 Loveton Circle SE DECISION MADE: 21-DEC-22
Sparks MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
Drägerwerk AG & Co. KGaA 510(k) NO: K221836(Traditional)
ATTN: Luise Lang PHONE NO : 49 451 8826145
Moislinger Allee 53-55 SE DECISION MADE: 07-DEC-22
Lüebeck DE 23542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
Roche Diagnostics 510(k) NO: K221842(Traditional)
ATTN: Greg Mondics PHONE NO : 317 6008647
9115 Hague Rd. SE DECISION MADE: 07-DEC-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atalante
Wandercraft SAS 510(k) NO: K221859(Traditional)
ATTN: Matthieu Masselin PHONE NO : 33 6 61228845__
88 rue de Rivoli SE DECISION MADE: 29-DEC-22
Paris FR 75004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YY-A02-B Overlapped Compression Therapy
Huizhou XINYI Technology Co., LTD.510(k) NO: K221862(Traditional)
ATTN: Jason Ye PHONE NO : 861 812 9657928
Area (Building 3), Changbu VillageSE DECISION MADE: 08-DEC-22
Huizhou CN 516200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNO Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc 510(k) NO: K221891(Special)
ATTN: Andrew Goh PHONE NO : 516 4878787___
16 Midland Ave SE DECISION MADE: 14-DEC-22
Hicksville NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BreathID Hp System
Meridian Bioscience Israel Ltd. 510(k) NO: K221896(Special)
ATTN: Raffi Werner PHONE NO : 972 8 9737502
4 Ha'Maayan St SE DECISION MADE: 19-DEC-22
Modiin IL 7177872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LimFlow Vector
LimFlow, Inc. 510(k) NO: K221902(Traditional)
ATTN: Zachary Woodson PHONE NO : 1 707 3286522
3031 Tisch Way - 110 Plaza West SE DECISION MADE: 21-DEC-22
San Jose CA 95128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EK12 V2 Algorithm
GE Medical Systems Information Tec510(k) NO: K221904(Traditional)
ATTN: Shlomi Deler PHONE NO : 972 544 301056
9900 Innovation Drive SE DECISION MADE: 20-DEC-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QRS Dental Implants System
QRS Medical Ltd. 510(k) NO: K221910(Traditional)
ATTN: Iman Khorshid PHONE NO : 972 54 3023043
Toval SE DECISION MADE: 14-DEC-22
Ma’alot-Tarshiha IL 2101001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
VINNO Technology (Suzhou) Co.,Ltd.510(k) NO: K221911(Special)
ATTN: Cordelia Liu PHONE NO : 86 512 62873806
5F Building A,4F Building C No. 27SE DECISION MADE: 21-DEC-22
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus® Bone Cement, Invictus Spinal Fixation System
Alphatec Spine, Inc. 510(k) NO: K221926(Traditional)
ATTN: Aditya Aiyer PHONE NO : 760 4946671
1950 Camino Vide Roble SE DECISION MADE: 20-DEC-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeR Syringe and SafeR Sting
Roncadelle Operations srl 510(k) NO: K221981(Traditional)
ATTN: Massimo Rossi PHONE NO : 39 030 6724322
Via Renolda 10 SE DECISION MADE: 29-DEC-22
Castel Mella (Brescia) IT 25030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access Total ßhCG (5th IS)
Beckman Coulter, Inc 510(k) NO: K221990(Traditional)
ATTN: Kate Oelberg PHONE NO : 612 4317315
1000 Lake Hazeltine Drive SE DECISION MADE: 27-DEC-22
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persyst 15 EEG Review and Analysis Software
Persyst Development Corporation 510(k) NO: K222002(Traditional)
ATTN: Dari Darabbeigi PHONE NO : 858 4614542 109
420 Stevens Avenue Suite 210 SE DECISION MADE: 30-DEC-22
Solana Beach CA 92075 510(k) STATEMENT
DEVICE: Biobeat Platform-2 and BB-613WP Patch
BioBeat Technologies Ltd. 510(k) NO: K222010(Traditional)
ATTN: Johanan May PHONE NO : 972 3 9333022
26 Ha'magshimim Street SE DECISION MADE: 30-DEC-22
Petah Tikvah IL 4934835 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
Stryker Sustainability Solutions 510(k) NO: K222019(Traditional)
ATTN: Michael Wong PHONE NO : 480 2131342
1810 W Drake Drive SE DECISION MADE: 04-DEC-22
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
Abbott (formerly Thoratec Corporat510(k) NO: K222038(Traditional)
ATTN: Meera Mehta PHONE NO : 925 3156483___
6035 Stoneridge Drive SE DECISION MADE: 08-DEC-22
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inogen Rove 4 Portable Oxygen Concentrator
Inogen 510(k) NO: K222086(Traditional)
ATTN: Sandra LeClair PHONE NO : 315 8681202
301 Coromar Drive SE DECISION MADE: 09-DEC-22
Goleta CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swang-Ganz IQ pulmonary artery catheter
Edwards Lifesiences, LLC 510(k) NO: K222117(Traditional)
ATTN: Michelle Ducca PHONE NO : 805 3686785
1 Edwards Way SE DECISION MADE: 09-DEC-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2-Way 100% Silicone Cleartract Catheter
SILQ Technologies, Corp. 510(k) NO: K222118(Traditional)
ATTN: D. Verne Sharma PHONE NO : 424 3098727
323 Sunny Isles Blvd., 7th Floor SE DECISION MADE: 01-DEC-22
Sunny Isles Beach FL 33160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G
Shenzhen AOJ Medical Technology Co510(k) NO: K222125(Traditional)
ATTN: Jack Wang PHONE NO : 86 755 27786026__
Room 301&4F, Blk A, Building A, JiSE DECISION MADE: 01-DEC-22
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OK Plus Indicator
Propper Manufacturing Co., Inc. 510(k) NO: K222137(Abbreviated)
ATTN: Andrew Sharavara PHONE NO : 718 8691252
36-04 Skillman Avenue SE DECISION MADE: 05-DEC-22
Long Island City NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visant Medical Canalicular Plug
Visant Medical, Inc. 510(k) NO: K222164(Traditional)
ATTN: Vartan Ghazarossian PHONE NO :
801 Hermosa Way SE DECISION MADE: 23-DEC-22
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aprevo® Digital Workflow
Carlsmed, Inc. 510(k) NO: K222195(Traditional)
ATTN: Karen Liu PHONE NO : 760 7601926
1800 Aston Ave., Ste 100 SE DECISION MADE: 30-DEC-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
Unimed Medical Supplies, Inc. 510(k) NO: K222213(Traditional)
ATTN: Hui Zhang PHONE NO : 86 755 26695165
Bld#8, Nangang 3rd Industrial ParkSE DECISION MADE: 19-DEC-22
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruWave Disposable Pressure Transducer
Edwards Lifesciences LLC 510(k) NO: K222216(Traditional)
ATTN: Carmen Chen PHONE NO : 949 2502500
One Edwards Way SE DECISION MADE: 22-DEC-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViewFlex Xtra Reprocessed ICE Catheter
Abbott Medical 510(k) NO: K222217(Traditional)
ATTN: Quynh Phuong Le PHONE NO : 949 4699779
14901 Deveau Place SE DECISION MADE: 19-DEC-22
Minnetonka MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2 Studio Q/RCT820
MegaGen Implant CO., Ltd. 510(k) NO: K222219(Traditional)
ATTN: Yong Jae Kim PHONE NO : 82 53 2472261
45, Secheon-ro, 7-gil SE DECISION MADE: 06-DEC-22
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlucoSure ADVANCE Link Blood Glucose Monitoring System
Apex BioTechnology Corp. 510(k) NO: K222234(Special)
ATTN: Lisa Liu PHONE NO : 011 886 35641952
No. 7, Li-Hsin Road V, Hsinchu SciSE DECISION MADE: 21-DEC-22
Hsinchu CN 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FloPatch FP120
Flosonics Medical 510(k) NO: K222242(Traditional)
ATTN: Caleb Chin PHONE NO : 1 289 9982982
325 Front St W, Floor 4 SE DECISION MADE: 09-DEC-22
Toronto CA M5V 2Y1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunrise
Sunrise SA 510(k) NO: K222262(Traditional)
ATTN: Gregoire Lejeune PHONE NO : 32____ 81 261126
Chaussee de Marche 598/02 SE DECISION MADE: 22-DEC-22
Namur BE 5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Saige-Density
DeepHealth, Inc. 510(k) NO: K222275(Traditional)
ATTN: B. Nathan Hunt PHONE NO : 424 8321480
1000 Massachusetts Avenue SE DECISION MADE: 16-DEC-22
Cambridge MA 01238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CentriMag Pre-connected Pack
Abbott 510(k) NO: K222297(Traditional)
ATTN: Kim Bondarenko PHONE NO : 925 4607361
6035 Stoneridge Drive SE DECISION MADE: 01-DEC-22
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Al Smile Aligner
Nanjing Jiahe Dental Technology Co510(k) NO: K222308(Traditional)
ATTN: Charles Shen PHONE NO : 086___ 400 0880468
Room 201, Building 2, No.2 ShuanglSE DECISION MADE: 20-DEC-22
Nanjing CN 210000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedDream
Softneta UAB 510(k) NO: K222320(Traditional)
ATTN: Laura Baroniene PHONE NO : 370 68835432
K.Barsausko str. 59 SE DECISION MADE: 06-DEC-22
Kaunas LT 51423 510(k) STATEMENT
DEVICE: Chartis Precision Catheter
Pulmonx Corporation 510(k) NO: K222340(Traditional)
ATTN: Aniket Khakhadiya PHONE NO : 650 2160168
700 Chesapeake Road SE DECISION MADE: 01-DEC-22
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: inspired™ VHB20 Heated Humidifier
Vincent Healthcare Products Limite510(k) NO: K222351(Traditional)
ATTN: Patrick Dennis PHONE NO : 852___ 2186 1010
Flat/RM B2, 7/F., Hang Fung IndustSE DECISION MADE: 21-DEC-22
Hung Hom HK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System - Lightning Flash
Penumbra, Inc. 510(k) NO: K222358(Traditional)
ATTN: Deanna Kimlinger PHONE NO : 925 2129088
One Penumbra Place SE DECISION MADE: 20-DEC-22
Alameda CA 95132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIST IC
Imagine Milling Technologies, LLC 510(k) NO: K222368(Traditional)
ATTN: Felix Chung PHONE NO : 1 888 6354999
14220 Sullyfield Circle, Suite B SE DECISION MADE: 01-DEC-22
Chantilly VA 20151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bifurcated Needle
Anhui Tiankang Medical Technology 510(k) NO: K222385(Traditional)
ATTN: Zhang Yong PHONE NO : 86 137 05505106
No.228,Weiyi Road, Economic DeveloSE DECISION MADE: 06-DEC-22
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart SPACE Shoulder Planner and 3D Positioners
LimaCorporate S.p.A 510(k) NO: K222405(Traditional)
ATTN: Francesca Marello PHONE NO : 39 043 2945511
Via Nazionale 52 SE DECISION MADE: 20-DEC-22
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasound System 2300
BK Medical Aps 510(k) NO: K222441(Traditional)
ATTN: Sandra Theodoridis PHONE NO : 978 5789353
Mileparken 34 SE DECISION MADE: 07-DEC-22
Herlev DK 2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRRAflow Active Fluid Exchange System (AFES)
IRRAS USA 510(k) NO: K222471(Special)
ATTN: Jeanne S Warner PHONE NO : 269 2702189
11975 El Camino Real, Suite 304 SE DECISION MADE: 08-DEC-22
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLICK (VARIANTS: POWER, RACE, MONSTER)
KLAXON Mobility GmbH 510(k) NO: K222502(Traditional)
ATTN: Riccardo Colomba PHONE NO : 0043 0 6763213105
Industriesrasse, 1 SE DECISION MADE: 16-DEC-22
Arnoldstein AT 9601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mercury® II Spinal System
Spinal Elements, Inc. 510(k) NO: K222516(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 01-DEC-22
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Glove
PingAn Medical Products Co.,Ltd. 510(k) NO: K222527(Traditional)
ATTN: Zhou Ziyu PHONE NO : 86 15 247135174
Zheji Road, High-tech Industrial ZSE DECISION MADE: 14-DEC-22
Jiujiang CN 332599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
Well-Life Healthcare Limited 510(k) NO: K222528(Traditional)
ATTN: Jenny Hsieh PHONE NO : 886 2 22266981
6F., No. 168. de St., Jhonghe DistSE DECISION MADE: 29-DEC-22
New Taipei City TW 235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Target Tetra Detachable Coils
Stryker Neurovascular 510(k) NO: K222533(Traditional)
ATTN: Jonathan Bemben PHONE NO : 651 2028121
47900 Bayside Parkway SE DECISION MADE: 14-DEC-22
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
Sino Medical Sciences Technology I510(k) NO: K222538(Traditional)
ATTN: Jianhua Sun PHONE NO : 86 022 59862900
TEDA Biopharm Research, #5, 4th StSE DECISION MADE: 21-DEC-22
Tianjin CN 300457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Bausch & Lomb Incorporated 510(k) NO: K222541(Traditional)
ATTN: Melissa Thomas PHONE NO : 585 3386045
1400 N Goodman Street SE DECISION MADE: 06-DEC-22
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
Stryker Instruments 510(k) NO: K222552(Traditional)
ATTN: Tu Nguyen PHONE NO : 817 9324541___
1941 Stryker Way SE DECISION MADE: 09-DEC-22
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HurriChem Device Kit
ThermaSolutions LLC 510(k) NO: K222575(Traditional)
ATTN: Gregg Giza PHONE NO : 1 877 9526100
1889 Buerkle Road SE DECISION MADE: 06-DEC-22
St. Paul MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mural Clinical Viewer
GE Medical Systems Information Tec510(k) NO: K222586(Traditional)
ATTN: Brandon O'Shea PHONE NO : 414 3233147
9900 Innovation Drive SE DECISION MADE: 21-DEC-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Tuttnauer LTD. 510(k) NO: K222608(Traditional)
ATTN: Robert Basile PHONE NO : 631 7374850
Har-Tuv Industrial Zone SE DECISION MADE: 16-DEC-22
Beit-Shemesh IL 9910101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation Spinal System
Zavation Medical Products, LLC 510(k) NO: K222614(Traditional)
ATTN: Frankie Cummins PHONE NO : 601 9191119
3670 Flowood Drive SE DECISION MADE: 05-DEC-22
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Crown
SprintRay Inc. 510(k) NO: K222623(Traditional)
ATTN: Sara Moghtadernejad PHONE NO : 917 9123858
2705 Media Center Drive, Suite 100SE DECISION MADE: 14-DEC-22
Los Angeles CA 90065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Zirconia Ceramic
Aidite (Qinhuangdao) Technology Co510(k) NO: K222626(Traditional)
ATTN: Chen Yingying PHONE NO : 86 335 8357346
No. 9 Dushan Road, Economic and TeSE DECISION MADE: 06-DEC-22
Qinhuangdao CN 066004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriMed Wrist Fixation System 3
TriMed, Inc. 510(k) NO: K222637(Traditional)
ATTN: David Medoff PHONE NO : 661 2557406
27533 Avenue Hopkins SE DECISION MADE: 21-DEC-22
Santa Clarita CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
Stryker Craniomaxillofacial (CMF) 510(k) NO: K222650(Traditional)
ATTN: Zainab Amini PHONE NO : 269 2908072
1941 Stryker Way SE DECISION MADE: 09-DEC-22
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Xiantao Sanda Industrial Co., Ltd 510(k) NO: K222651(Traditional)
ATTN: Rong Min PHONE NO : 86 728 3221235___
No. 46 Golden Avenue SE DECISION MADE: 13-DEC-22
Xiantao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cryopush Cold Compression Device
Chengdu Cryo-Push Medical Technolo510(k) NO: K222669(Traditional)
ATTN: Zhang Peiyong PHONE NO : 86 180 86852687__
102, 105, Zone 20, Huayin IndustriSE DECISION MADE: 05-DEC-22
Chengdu CN 611137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altaviz Needle Kit
Altaviz, LLC 510(k) NO: K222681(Traditional)
ATTN: James Lescoulie PHONE NO : 310 5691105
13766 Alton Parkway, Suite 143 SE DECISION MADE: 05-DEC-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mallya Injection Pen Adapter (Mallya® for Solostar®)
Biocorp Production 510(k) NO: K222689(Traditional)
ATTN: Alexia Garin PHONE NO : 33 6 42278694
Zi Lavaur -La Béchade SE DECISION MADE: 05-DEC-22
Issoire FR 63500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K222692(Traditional)
ATTN: Amalia Schreier PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 05-DEC-22
Tel Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iCE-SG2 Subcutaneous Electrode Kit
iCE Neurosystems, Inc. 510(k) NO: K222706(Traditional)
ATTN: Emir Kapetanovic PHONE NO : 202 9183205
1054 31st Street NW, Suite 300 SE DECISION MADE: 06-DEC-22
Washington DC 20007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Cooling Hair Removal Device
Shenzhen Siken 3D Technology Devel510(k) NO: K222710(Traditional)
ATTN: Jingquan Liu PHONE NO : 86 150 12555680
4th Building,No.33 Left East AvenuSE DECISION MADE: 01-DEC-22
Shenzhen CN 518105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: White Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (HK) Limited 510(k) NO: K222713(Traditional)
ATTN: Alvin Ho PHONE NO : 60____ 12 8265625
26th Floor, Beautiful Group Tower,SE DECISION MADE: 03-DEC-22
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (HK) Limited 510(k) NO: K222715(Traditional)
ATTN: Alvin Ho PHONE NO : 60____ 12 8265625
26th Floor, Beautiful Group Tower,SE DECISION MADE: 03-DEC-22
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (HK) Limited 510(k) NO: K222720(Traditional)
ATTN: Alvin Ho PHONE NO : 60 128 265625
26th Floor, Beautiful Group Tower,SE DECISION MADE: 03-DEC-22
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smartpump 3.0 Double Electric Breast Pump
Lansinoh Laboratories 510(k) NO: K222726(Traditional)
ATTN: Lindsay Ewers PHONE NO : 703 2606963___
99 Canal Center Plaza, Suite 550 SE DECISION MADE: 23-DEC-22
Alexandria VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
Inner Mongolia Boming Medical Supp510(k) NO: K222733(Traditional)
ATTN: Guo Hua PHONE NO : 86 1348 5097856
Room 326, New Industrial Park ManaSE DECISION MADE: 11-DEC-22
Baotou CN 014017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ShiNeo Silicone Implant
Shineo Technology Co., Ltd 510(k) NO: K222748(Traditional)
ATTN: Wan-Chun Lai PHONE NO : 886 02 22021511
5F, 207-4, XINSHU ROAD., SE DECISION MADE: 23-DEC-22
NEW TAIPEI CITY TW 24262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yomi Robotic System
Neocis Inc. 510(k) NO: K222750(Traditional)
ATTN: Joshua Davis PHONE NO : 508 2940749
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 08-DEC-22
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine 7D Navigation Instruments
SeaSpine Orthopedics Corporation 510(k) NO: K222753(Traditional)
ATTN: Laeitia Cousin PHONE NO : 760 2165122
5770 Armada Drive SE DECISION MADE: 09-DEC-22
Carlsband CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StageOne™ Select Hip Cement Spacer Molds
Biomet, Inc. 510(k) NO: K222760(Traditional)
ATTN: Meredith Reed PHONE NO : 574 2096028___
56 East Bell Drive, P.O. Box 587 SE DECISION MADE: 28-DEC-22
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PeekMed web (v1)
Peek Health, S.A. 510(k) NO: K222767(Traditional)
ATTN: Sara Silva PHONE NO : 351 935 147151
Centro de Negócios Ideia AtlânticoSE DECISION MADE: 30-DEC-22
Braga PT 4719-005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Conductive Gel
Top-Rank Health Care Co.,Ltd. 510(k) NO: K222770(Traditional)
ATTN: Gangfeng Lou PHONE NO : 86 0575 82912999
Mashan Village, Dongguan Street, SSE DECISION MADE: 13-DEC-22
Shaoxing CN 312300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iFuse Bedrock Granite® Implant System
SI-BONE, Inc. 510(k) NO: K222774(Traditional)
ATTN: Meirav Harsat PHONE NO : 650 8624942
471 El Camino Real, Suite 101 SE DECISION MADE: 22-DEC-22
Santa Clara CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rejoni Intrauterine Catheter
Rejoni, Inc. 510(k) NO: K222798(Traditional)
ATTN: Brian Bergeron PHONE NO : 781 7351 5902220081
201 Burlington Road SE DECISION MADE: 16-DEC-22
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kodiak C Spinal Implant System
Met One Technologies, LLC 510(k) NO: K222806(Traditional)
ATTN: Adrian Carbonell PHONE NO : 915 3733855
513 W. San Antonio Ave, Suite C SE DECISION MADE: 22-DEC-22
El Paso TX 79901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System (Reperfusion Catheter RED 43)
Penumbra, Inc. 510(k) NO: K222808(Traditional)
ATTN: Micaela Victoria PHONE NO : 510 9952082
One Penumbra Place SE DECISION MADE: 20-DEC-22
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
Zibo Lanhua Medical Packaging Mate510(k) NO: K222815(Traditional)
ATTN: Lily Wang PHONE NO : 86 533 7871089
No. 21 Qingtian Road, Xindian StreSE DECISION MADE: 04-DEC-22
Zibo CN 255414 510(k) STATEMENT
DEVICE: BRM TOOL Screws, BIOPLAN Subtalar Implant
BRM Extremities 510(k) NO: K222820(Traditional)
ATTN: Lisa Fazzini PHONE NO : 39 0341 1693087
Via Papa Giovanni XXIII, 9 SE DECISION MADE: 16-DEC-22
Civate IT 23862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Spectranetics Inc. 510(k) NO: K222837(Special)
ATTN: Taylor Olen PHONE NO : 719 4374129
9965 Federal Drive SE DECISION MADE: 08-DEC-22
Colorado Springs CO 80921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8MP Color LCD Monitor CL-R813
JVCKENWOOD Corporation 510(k) NO: K222864(Traditional)
ATTN: Hideki Tengeiji PHONE NO : 81 45 4502715
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 21-DEC-22
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
Andon Health Co., Ltd. 510(k) NO: K222867(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 21-DEC-22
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DNA Appliance
Vivos Therapeutics, Inc. 510(k) NO: K222872(Traditional)
ATTN: Kimberly Griffith PHONE NO : 270 2269237
300 S. 5th Street SE DECISION MADE: 30-DEC-22
Murray KY 42017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
Grand Work Plastic Products Co., L510(k) NO: K222892(Traditional)
ATTN: Wu Yuli PHONE NO : 86 311 66179668
Donggao Industrial Zone, Zanhuang SE DECISION MADE: 15-DEC-22
Shijiazhuang CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invisalign System, Pre-Formed Attachment System
Align Technology, Inc. 510(k) NO: K222894(Traditional)
ATTN: Manjunath Bisalehalli PHONE NO : 1 412 2984604___
2820 Orchard Parkway SE DECISION MADE: 22-DEC-22
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirRay
POSKOM Co.,Ltd. 510(k) NO: K222896(Traditional)
ATTN: Jeong Hyun Seong PHONE NO :
POSKOM Tower, 227 Sowon-ro, DeogyaSE DECISION MADE: 20-DEC-22
Goyang-si KR 10534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: US 450 Diode Laser Equipment
Beijing Globalipl Development Co.,510(k) NO: K222916(Traditional)
ATTN: Liu Jun PHONE NO : 86 151 69727366
F-8 Qunyinghui Building, Jinyuan RSE DECISION MADE: 09-DEC-22
Beijing CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE® ENFORM Biomaterial
W. L. Gore and Associates, Inc. 510(k) NO: K222919(Traditional)
ATTN: Barbara L Smith PHONE NO : 410 5068189___
301 Airport Road SE DECISION MADE: 19-DEC-22
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leg Massager RF-ALM070
Shenzhen Ruiyi Business Technology510(k) NO: K222924(Traditional)
ATTN: Jacky Li PHONE NO : 86 158 99775010
Qianhai Complex A201, Qianwan RoadSE DECISION MADE: 23-DEC-22
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Leg Massager (Model: LY-670D)
Zhejiang Luyao Electronics Technol510(k) NO: K222949(Traditional)
ATTN: Joyce Lin PHONE NO : 86 577 63775005
Wei 1st Road, Mechanical Park, WanSE DECISION MADE: 22-DEC-22
Wenzhou CN 325409 510(k) STATEMENT
DEVICE: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Xiros Ltd 510(k) NO: K222978(Traditional)
ATTN: Steve Curran PHONE NO : 44 113 2387200
Springfield House Lane, WhitehouseSE DECISION MADE: 27-DEC-22
Leeds GB LS17 7UE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioClean Implant Restorative System
BioClean Dental, LLC 510(k) NO: K222984(Traditional)
ATTN: Russ Bonafede PHONE NO : 1 858 7841388
6088 Eagles Nest Drive SE DECISION MADE: 29-DEC-22
Jupiter FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves
Jiangxi Handspro Products Solution510(k) NO: K223004(Traditional)
ATTN: Jun Yin PHONE NO : 86____ 186 16636918
Chuangye Avenue, Fenglin IndustriaSE DECISION MADE: 04-DEC-22
Jiujiang CN 330406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3-Ply Disposable Medical Mask
Wealth Lead Industrial Limited 510(k) NO: K223045(Traditional)
ATTN: Ethel Chiu Man Mok PHONE NO : 852 3170 3219
2/F, Kras Asia Industrial BuildingSE DECISION MADE: 07-DEC-22
Hong Kong CN 0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
MicroVention Inc. 510(k) NO: K223050(Traditional)
ATTN: Riddhi Pandya PHONE NO : 646 7248792
35 Enterprise SE DECISION MADE: 21-DEC-22
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask
Xiantao Zhuobo Industrial Co., LTD510(k) NO: K223055(Traditional)
ATTN: Chen Xiaodong PHONE NO : 86 18 500056172
Building 1,Huanxi Road, Pengchang SE DECISION MADE: 05-DEC-22
Xiantao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xenoview VDP
Polarean, Inc. 510(k) NO: K223071(Traditional)
ATTN: Neil Wadehra PHONE NO : 919 2067900
PO Box 14805 SE DECISION MADE: 23-DEC-22
Research Triangle Park NC 27709-4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Esophagoscope EE17-J10
PENTAX of America, Inc. 510(k) NO: K223072(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 02-DEC-22
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViewFlex Xtra ICE Catheter
Irvine Biomedical, a St. Jude Medi510(k) NO: K223077(Special)
ATTN: Suzanne Pekarna PHONE NO : 651 7564601
2375 Morse Ave SE DECISION MADE: 07-DEC-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License
Abbott Medical 510(k) NO: K223094(Traditional)
ATTN: Alyssa Timmers PHONE NO : 651 7563706
One St. Jude Medical Device SE DECISION MADE: 27-DEC-22
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tesera-K SC System
Kyocera Medical Technologies, Inc.510(k) NO: K223105(Traditional)
ATTN: Scott Rucker PHONE NO : 909 7577509
1200 California Street Suite 210 SE DECISION MADE: 22-DEC-22
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAVERICK Mini External Fixation System
Smith & Nephew, Inc. 510(k) NO: K223112(Traditional)
ATTN: Allison Francis PHONE NO : 901 5725959
7135 Goodlett Farms Parkway SE DECISION MADE: 08-DEC-22
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEON-C™ Stand Alone System
Dio Medical Inc 510(k) NO: K223140(Traditional)
ATTN: Milan George PHONE NO : 716 4655551
2100 Campus Ln Suite 100 SE DECISION MADE: 20-DEC-22
East Norriton PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coltolux Comfort LED Curing Light
Dent4You AG 510(k) NO: K223142(Traditional)
ATTN: Dr. Tricia Cregger PHONE NO : 330 9168904
Bahnhofstrasse 2 SE DECISION MADE: 22-DEC-22
Heerbrugg CH 9435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K223153(Traditional)
ATTN: Alex Underberg PHONE NO : 901 3441443
1800 Pyramid Place SE DECISION MADE: 16-DEC-22
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phantom Metatarsal Shortening System
Paragon 28, Inc. 510(k) NO: K223184(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 16-DEC-22
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hive™ Standalone Cervical System
NanoHive Medical LLC 510(k) NO: K223190(Traditional)
ATTN: Ian Helmar PHONE NO : 844 9435433
12 Gill Street Suite 4500 SE DECISION MADE: 12-DEC-22
Wobum MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIROS 8P Sequential Compression Device
AIROS Medical, Inc 510(k) NO: K223193(Traditional)
ATTN: Darren Behuniak PHONE NO : 1 866 9916956
2501 Monroe Blvd. Suite 1200 SE DECISION MADE: 09-DEC-22
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIROS 6P Sequential Compression Device
AIROS Medical, Inc 510(k) NO: K223195(Traditional)
ATTN: Darren Behuniak PHONE NO : 1 866 9916956
2501 Monroe Blvd. Suite 1200 SE DECISION MADE: 09-DEC-22
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INHANCETM Shoulder System – Humeral Stems and Stemless
Depuy Ireland UC 510(k) NO: K223211(Traditional)
ATTN: Yayoi Fujimaki PHONE NO : 508 8283541
Loughbeg SE DECISION MADE: 02-DEC-22
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parietene Macroporous Mesh
Sofradim Production 510(k) NO: K223218(Special)
ATTN: Jhony Mallet PHONE NO : 33 474 089000
116 Avenue du Formans SE DECISION MADE: 02-DEC-22
Trevoux FR 01600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trigon™ HA Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies, I510(k) NO: K223226(Special)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 01-DEC-22
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SofWave System
Sofwave Medical Ltd. 510(k) NO: K223237(Traditional)
ATTN: Ruthie Amir PHONE NO : 97 254 3003164
1 Ha-Otsma St. SE DECISION MADE: 16-DEC-22
Yokneam Ilit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8ch Wrist Coil
Shenzhen RF Tech Co., Ltd. 510(k) NO: K223239(Traditional)
ATTN: Gary Wang PHONE NO : 0086 755 26641989 113
2-F, Bld4, Juhui Industrial Park, SE DECISION MADE: 08-DEC-22
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets
Becton, Dickinson and Company 510(k) NO: K223243(Traditional)
ATTN: Alexandra Kirby PHONE NO : 862 7742318
1 Becton Drive SE DECISION MADE: 16-DEC-22
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pristine Arthroscopic Visualization System
Pristine Surgical 510(k) NO: K223244(Special)
ATTN: Stewart B Davis PHONE NO : 603 2065597
Brady Sullivan Tower, 6th Floor, 1SE DECISION MADE: 21-DEC-22
Manchester NH 03104 510(k) STATEMENT
DEVICE: Swoop Portable MR Imaging System
Hyperfine, Inc. 510(k) NO: K223247(Special)
ATTN: Christine Kupchick PHONE NO : 203 3433404___
351 New Whitfield St. SE DECISION MADE: 06-DEC-22
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hexanium PLIF
SpineVision, S.A.S. 510(k) NO: K223251(Traditional)
ATTN: Quang Tran PHONE NO : 33 1 53332553
10 Rue de la Renaissance SE DECISION MADE: 16-DEC-22
Antony FR 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BrainInsight
Hyperfine, Inc. 510(k) NO: K223268(Traditional)
ATTN: Christine Kupchick PHONE NO : 203 3433404
351 New Whitfield St. SE DECISION MADE: 16-DEC-22
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRA Spine System
SpineCraft, LLC 510(k) NO: K223273(Traditional)
ATTN: Ami Akallal-Asaad PHONE NO : 1 630 9207300
777 Oakmont Lane, Suite 200 SE DECISION MADE: 22-DEC-22
Westmont IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLO II Balloon Guide Catheter
Fuji Systems Corporation 510(k) NO: K223275(Third Party - Traditional)
ATTN: Yoshiyuki Suzuki PHONE NO : 81 248 254501
200-2, Aza-Ohira, Odakura, NishigoSE DECISION MADE: 09-DEC-22
Nishi Shirakawa Gun JP 961-8061 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Disposable Nitrile Examination Glove
Anhui Kindguard Medical Supplies T510(k) NO: K223281(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
Southwest of Intersection of TonghSE DECISION MADE: 07-DEC-22
Suzhou CN 234300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD AutoShield Duo™ Pen Needle
Becton, Dickinson and Company 510(k) NO: K223286(Traditional)
ATTN: Alec Paterno PHONE NO : 908 6703376
1 Becton Drive SE DECISION MADE: 28-DEC-22
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access Vitamin B12
Beckman Coulter, Inc. 510(k) NO: K223289(Traditional)
ATTN: Kuljeet Kaur PHONE NO : 1 952 4651914
1000 Lake Hazeltine Drive SE DECISION MADE: 23-DEC-22
Chaska MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineJack® Expansion Kit
Stryker Instruments 510(k) NO: K223294(Traditional)
ATTN: Bruce Backlund PHONE NO : 763 7625902
1941 Stryker Way SE DECISION MADE: 20-DEC-22
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips CT 3500
Philips Healthcare (Suzhou) Co., L510(k) NO: K223311(Traditional)
ATTN: Xu Diana PHONE NO : 86 189 40060508
No.258, ZhongYuan Road, Suzhou IndSE DECISION MADE: 22-DEC-22
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Total Bilirubin2
Abbott Ireland Diagnostics Divisio510(k) NO: K223324(Traditional)
ATTN: Magdalena Suszko PHONE NO : 224 6679025
Lisnarnuck SE DECISION MADE: 29-DEC-22
Longford IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Needles for Single Use
Zhejiang kindly Medical Devices Co510(k) NO: K223334(Traditional)
ATTN: Zhang Qian PHONE NO : 86 138 58871856
No.758, 5th Binhai Road, Binhai InSE DECISION MADE: 16-DEC-22
Wenzhou CN 325000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DropSafeTM SicuraTM
Pikdare SpA 510(k) NO: K223353(Third Party - Traditional)
ATTN: Roberta Zanoni PHONE NO : 39 331 1825670___
Via Saldarini Catelli 10 SE DECISION MADE: 02-DEC-22
Casnate con Bernate IT 22070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
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: K223369(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5960 Heisley Road SE DECISION MADE: 02-DEC-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optima Coil System
Balt USA, LLC 510(k) NO: K223386(Special)
ATTN: Kavita Chandrashekar PHONE NO : 858 4051276
29 Parker SE DECISION MADE: 06-DEC-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
Visionary Optics LLC 510(k) NO: K223394(Special)
ATTN: Donald R. Sanders PHONE NO : 630 5309700
1325 Progress Drive SE DECISION MADE: 07-DEC-22
Front Royal VA 22630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemosIL von Willebrand Factor Antigen
Instrumentation Laboratory Co. 510(k) NO: K223402(Special)
ATTN: Nikita Malladi PHONE NO : 781 6743245
180 Hartwell Road SE DECISION MADE: 09-DEC-22
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON Anti-HAV; LIAISON XS
DiaSorin Inc. 510(k) NO: K223403(Special)
ATTN: Kerrie Oetter PHONE NO : 651 3699806
1951 Northwestern Ave. P.O. Box 28SE DECISION MADE: 09-DEC-22
Stillwater MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cios Select (VA21) Image Intensifier
Siemens Medical Solutions USA, Inc510(k) NO: K223409(Special)
ATTN: Patricia D. Jones PHONE NO : 678 5758832
40 Liberty Boulevard SE DECISION MADE: 06-DEC-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cios Select (VA21) Flat Panel
Siemens Medical Solutions USA, Inc510(k) NO: K223410(Special)
ATTN: Patricia D. Jones PHONE NO : 678 5758832
40 Liberty Boulevard SE DECISION MADE: 07-DEC-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantra QPlus System
HemoSonics, LLC 510(k) NO: K223433(Special)
ATTN: Deborah Winegar PHONE NO : 919 2446990
4020 Stirrup Creek Drive, Suite 10SE DECISION MADE: 13-DEC-22
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR 5300 and MR 7700 R11 MR Systems
Philips Medical Systems Nederlands510(k) NO: K223442(Special)
ATTN: Susan Quick PHONE NO : 1 440 8694612
Veenpluis 6 SE DECISION MADE: 23-DEC-22
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
Spectranetics Inc. 510(k) NO: K223472(Special)
ATTN: Jordan Baum PHONE NO : 719 2470183
9965 Federal Drive SE DECISION MADE: 15-DEC-22
Colorado Springs CO 80921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: reVive Light Therapy® Wrinkle and Acne LED Device
LED Technologies, Inc. 510(k) NO: K223482(Special)
ATTN: Lloyd Nelson PHONE NO : 303 7480545
12821 Starkey Rd., Suite 4900 SE DECISION MADE: 21-DEC-22
Largo FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InkSpace Imaging Body Array
InkSpace Imaging, Inc. 510(k) NO: K223487(Special)
ATTN: Peter Fischer PHONE NO : 925 4257410
5635 West Las Positas Blvd, Suite SE DECISION MADE: 08-DEC-22
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
Medtronic Inc. 510(k) NO: K223508(Special)
ATTN: Rajitha Nair PHONE NO : 609 7601907
7611 Northland Drive SE DECISION MADE: 22-DEC-22
Minneapolis MN 55448 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Matrix HA Fusion Porous Cervical IBF System
Innovasis, Inc. 510(k) NO: K223510(Special)
ATTN: Michael Thomas PHONE NO : 801 2612236___
614 E 3900 South SE DECISION MADE: 12-DEC-22
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph Vision Quadra PET/CT System
Siemens Medical Solutions USA, Inc510(k) NO: K223547(Special)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 22-DEC-22
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
L&K Biomed Co., Ltd. 510(k) NO: K223565(Special)
ATTN: Katherine Kim PHONE NO : 82 10 54770325
101, 201, 202 16-25, DongbaekjungaSE DECISION MADE: 23-DEC-22
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Boston Scientific Corporation 510(k) NO: K223592(Special)
ATTN: Kerri LaPlaca PHONE NO : 508 3820549___
100 Boston Scientific Way SE DECISION MADE: 29-DEC-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reflow System Mini and ReFlow Mini Flusher
Anuncia Medical, Inc. 510(k) NO: K223603(Special)
ATTN: Elsa Chi Abruzzo PHONE NO : 513 5006736
1355 N Scottsdale Rd, Suite 370 SE DECISION MADE: 29-DEC-22
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ControlSeal Electrode (ELSB)
Coapt 510(k) NO: K223605(Special)
ATTN: Kevin Dwyer PHONE NO : 844 2627800 716
303 W. Institute Pl. Suite 200 SE DECISION MADE: 30-DEC-22
Chicago IL 60610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Boston Scientific Corporation 510(k) NO: K223616(Special)
ATTN: Kyra McNamara PHONE NO : 508 3820375___
100 Boston Scientific Way SE DECISION MADE: 30-DEC-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premier's MultiMatch Universal Chameleon Restorative Composite
Premier Dental Products Company 510(k) NO: K223632(Third Party - Traditional)
ATTN: Jessica Huang PHONE NO : 610 2396000
1710 Romano Drive SE DECISION MADE: 06-DEC-22
Plymouth Meeting PA 19462-4500 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CLEAR+BRILLIANT TOUCH® Laser System
Solta Medical, Inc. 510(k) NO: K223647(Third Party - Traditional)
ATTN: Aditi Chaubal PHONE NO : 425 4202350 ______
11720 North Creek Pkway N. Suite 1SE DECISION MADE: 29-DEC-22
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VERTICALE® Navigation Instruments
Silony Medical GmbH 510(k) NO: K223649(Special)
ATTN: Ralf Klabunde PHONE NO : 49 0 7117825250
Leinfelder StraBe 60 SE DECISION MADE: 22-DEC-22
Leinfelden-Echterdingen DE D-7077510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medussa-PL Cage
Medyssey USA, Inc. 510(k) NO: K223654(Special)
ATTN: Youngsu Jang PHONE NO : 847 4270200
1302 Busch Pkwy SE DECISION MADE: 28-DEC-22
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-ray Flat Panel Detectors (EverestView 4343X)
CareRay Digital Medical Technology510(k) NO: K223687(Special)
ATTN: Xu Wei PHONE NO : 86 512 86860288
A2-201/B3-501, Biobay, 218 Xinghu SE DECISION MADE: 30-DEC-22
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 287
TOTAL WITH SUMMARIES 280
TOTAL WITH STATEMENTS 7
