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  1. 510(k) Clearances

July 2022 510(K) Clearances

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


DEVICE: ROTEM sigma Thromboelastometry System
Tem Innovations GmbH              510(k) NO: K201440(Traditional)
ATTN: David  Jacob                PHONE NO : 49 89 45429523 
Martin-Kollar-Strasse 15          SE DECISION MADE: 08-JUL-22
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiviTum TKa
Biovica International AB          510(k) NO: K202852(Traditional)
ATTN: Wing  Cheng                 PHONE NO : 46 073 1259245 
Dag Hammarskjölds väg 54B         SE DECISION MADE: 29-JUL-22
Uppsala  SE 75237                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AGNES
Agnes Medical CO., LTD            510(k) NO: K203013(Traditional)
ATTN: Chul  Lee                   PHONE NO : 82 31 80209702 
(Seohyeon-Dong, 5fCocoplaza), 20, SE DECISION MADE: 14-JUL-22
Seongnam-Si  KR 13591             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hanger Cranial Band 3D
Symbion Logistics, LLC            510(k) NO: K203134(Traditional)
ATTN: Roselle  Abad               PHONE NO : 480 8941755 
1119 W Geneva Dr                  SE DECISION MADE: 01-JUL-22
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Veuron-Brain-mN1
Heuron Co., Ltd.                  510(k) NO: K203279(Traditional)
ATTN: Dong Hoon Shin              PHONE NO : 82 32 4298508 
10th Floor, 7, Mirae-ro, Namdong-gSE DECISION MADE: 12-JUL-22
Incheon  KR 21558                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioFire JI Control Panel M420
Maine Molecular Quality Controls, 510(k) NO: K203680(Traditional)
ATTN: Joan  Gordon                PHONE NO : 207 8851072 
23 Mill Brook Road                SE DECISION MADE: 22-JUL-22
Saco ME  04072                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Minuteful - kidney test
Healthy.io Ltd.                   510(k) NO: K210069(Traditional)
ATTN: Ron  Zohar                  PHONE NO : 972 54 4454514 
2 Ibn Gabirol St.                 SE DECISION MADE: 06-JUL-22
Tel Aviv  IL 6407702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin IPS Preprosthetic
KLS-Martin L.P.                   510(k) NO: K210228(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 904 6417746 8005
11201 Saint Johns Industrial ParkwSE DECISION MADE: 08-JUL-22
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SNUCONE Bone Level Implant System
SNUCONE Co., LTD.                 510(k) NO: K210354(Traditional)
ATTN: Ji Eun Song                 PHONE NO : 82 53 5927525 
5, Seongseo-ro 75-gil             SE DECISION MADE: 13-JUL-22
Dalseo-gu  KR 42703               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nerve Tape
BioCircuit Technologies, Incorpora510(k) NO: K210665(Traditional)
ATTN: Jack  Griffis               PHONE NO : 404 5836889 
1819 Peachtree Road NE, STE 205   SE DECISION MADE: 15-JUL-22
Atlanta GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin Individual Patient Solutions
KLS-Martin L.P.                   510(k) NO: K210731(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 Saint Johns Industrial PKWY SE DECISION MADE: 18-JUL-22
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIDAS NEPHROCHECK
bioMérieux SA                     510(k) NO: K210793(Traditional)
ATTN: Julien Thao My              PHONE NO : 33 4 78877064 
376 Chemin de l’Orme              SE DECISION MADE: 08-JUL-22
Marcy l’Etoile  FR 69280          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DeepRhythmAI
Medicalgorithmics S.A.            510(k) NO: K210822(Traditional)
ATTN: Marek  Dziubinski           PHONE NO : 48 22 8251249 
Aleje Jerozolimskie 81            SE DECISION MADE: 27-JUL-22
Warsaw  PL 02-001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA Ro52, EliA Ro60
Phadia AB                         510(k) NO: K210902(Traditional)
ATTN: Sheryl  Skinner             PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 27-JUL-22
Uppsala  SE                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
Becton, Dickinson and Company     510(k) NO: K211085(Traditional)
ATTN: Shan  Lu                    PHONE NO : 801 2304317 
1 Becton Drive                    SE DECISION MADE: 01-JUL-22
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental diode laser, SOGA Laser, ILaser II
Shenzhen Soga Technology Co., Ltd.510(k) NO: K211150(Abbreviated)
ATTN: Tse  Adrian                 PHONE NO : 086 159 15873605 
D906, Yinxing Technology Building SE DECISION MADE: 01-JUL-22
Shenzhen  CN 518110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew Hip Systems
Smith & Nephew, Inc.              510(k) NO: K211176(Traditional)
ATTN: Crystal  Higgenbottom-ShaffePHONE NO : 901 2811627 
1450 East Brooks Rd               SE DECISION MADE: 01-JUL-22
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLUE 400
Carl Zeiss Meditec AG             510(k) NO: K211346(Traditional)
ATTN: Hans-Joachim  Miesner       PHONE NO : 49 364 1220362 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 22-JUL-22
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tablo Hemodialysis System
Outset Medical, Inc.              510(k) NO: K211370(Traditional)
ATTN: Jennifer  Mascioli-Tudor    PHONE NO : 669 2318200 
3052 Orchard Drive                SE DECISION MADE: 29-JUL-22
San Jose CA  95134                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KeriFlex® MCP and PIP Finger Joint Prostheses
Keri Medical SA                   510(k) NO: K211385(Traditional)
ATTN: Bernard  Prandi             PHONE NO : 41 58 2550130 
Route des Acacias, 45a            SE DECISION MADE: 27-JUL-22
Geneva  CH CH-1227                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown
Barco Tekstil Sanayi ve Ticaret A.510(k) NO: K211399(Traditional)
ATTN: Emre  Gomruk                PHONE NO : 90 850 3037441 
Muratbey Mahallesi Karatoprak CaddSE DECISION MADE: 22-JUL-22
Istanbul  TR TR 34540             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TransLoc 3D
Foundation Fusion Solutions, LLC (510(k) NO: K211496(Traditional)
ATTN: Robert  Compton             PHONE NO : 888 7438736 
11916 S. Oxford Ave., Suite 206   SE DECISION MADE: 27-JUL-22
Tulsa OK  74137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wei Nasal Jet Tube
Well Lead Medical Co., LTD.       510(k) NO: K211543(Traditional)
ATTN: Caroline  Gong              PHONE NO : 86 20 84758878 
C-4 Jinhu Industrial Estate HualonSE DECISION MADE: 21-JUL-22
Guangzhou  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bodyport Cardiac Scale
Bodyport Inc.                     510(k) NO: K211585(Third Party - Traditional)
ATTN: Mara  Korsunsky             PHONE NO : 650 2001557 
970 Folsom Street                 SE DECISION MADE: 29-JUL-22
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Planmed Clarity 2D, Planmed Clarify S
Planmed Oy                        510(k) NO: K211720(Traditional)
ATTN: Niina  Vuorikallas          PHONE NO : 35 820 7795500 
Sorvaajankatu 7                   SE DECISION MADE: 18-JUL-22
Helsinki  FI 00880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DM Converter - TiN coated
Medacta International S.A.        510(k) NO: K211891(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 22-JUL-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTI Interna Narrow/Plus Dental Implant System UnicCa
B.T.I. Biotechnology Institute, SL510(k) NO: K211952(Traditional)
ATTN: Jose Ramon Rivero           PHONE NO : 0034 945 297030 
Leonardo Da Vinci 14, Parque TecnoSE DECISION MADE: 21-JUL-22
Minano  ES 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alma Diode Tabletop Laser
Alma Lasers, Ltd.                 510(k) NO: K212073(Traditional)
ATTN: Avi  Hirshnzon              PHONE NO : 972 54 3303402 
18 Haharash Street, North IndustriSE DECISION MADE: 14-JUL-22
Caesarea  IL 3079895              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagXtract Collection Tube
MagBio Genomics, Inc.             510(k) NO: K212113(Traditional)
ATTN: Mothomang  Mlalazi-Oyinloye PHONE NO : 301 3020144 
944 Clopper Rd                    SE DECISION MADE: 28-JUL-22
Gaithersburg MD  20878            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Root Apex Locator
Foshan COXO Medical Instrument Co.510(k) NO: K212178(Traditional)
ATTN: Yongjian  Zheng             PHONE NO : 86 137 02544788 
BLDG 4, District A, Guangdong New SE DECISION MADE: 20-JUL-22
Foshan  CN 528226                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tiche PTA Balloon Dilatation Catheter
BrosMed Medical Co., Ltd.         510(k) NO: K212215(Traditional)
ATTN: Crystal  Lee                PHONE NO : 86 769 22892018 
2nd and 15th Buildings, SMEs VentuSE DECISION MADE: 19-JUL-22
Dongguan  CN 523808               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gastric Lightguide (GLG)
Naser Dib Gabinet Lekarksi Nasmed 510(k) NO: K212407(Traditional)
ATTN: Naser  Dib                  PHONE NO : 48 721 000112 
Ul Jana Nowaka Jezioranskiego 7/18SE DECISION MADE: 26-JUL-22
Warszawa  PL 03-984               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AgeJet
Triworks Group SRL                510(k) NO: K212472(Traditional)
ATTN: Elio Piero Berchicci        PHONE NO : 0039 0874 1896435 
Via Don Giuseppe Mucciardi, 5     SE DECISION MADE: 07-JUL-22
Campochiaro  IT 86020             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSIX Breeze
Datum Dental Ltd.                 510(k) NO: K212509(Traditional)
ATTN: Arie  Goldlust              PHONE NO : 972 8 6705400 
1 Bat Sheva St., PO Box 6170      SE DECISION MADE: 18-JUL-22
Lod  IL 7116003                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasonic Scalpel System
Surgnova Healthcare Technologies (510(k) NO: K212614(Traditional)
ATTN: Guofang  Ma                 PHONE NO : 86 10 64116115 
No.1 XinXing Yilu Road, Emerging ISE DECISION MADE: 18-JUL-22
Cixi  CN 315301                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Adin Short Implants
Adin Dental Implants Systems Ltd. 510(k) NO: K212775(Traditional)
ATTN: Iris  Yadin-Herling         PHONE NO : 972 4 6426732 
Alon Tavor Industrial Zone, P.O. BSE DECISION MADE: 08-JUL-22
Afula  IL 1811101                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
Abbott Molecular, Inc.            510(k) NO: K212778(Traditional)
ATTN: Gina  Sammarco              PHONE NO : 224 3617627 
1300 E. Touhy Ave                 SE DECISION MADE: 15-JUL-22
Des Plaines IL  60018             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProstatID
ScanMed, LLC                      510(k) NO: K212783(Traditional)
ATTN: Randall  Jones              PHONE NO : 402 9342650 
9840 S 140 Street, Suite #8       SE DECISION MADE: 08-JUL-22
Omaha NE  68138                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: My3D® Personalized Pelvic Reconstruction
Onkos Surgical                    510(k) NO: K212815(Traditional)
ATTN: Matthew  Vernak             PHONE NO : 551 5791081 
77 East Halsey Rd.                SE DECISION MADE: 06-JUL-22
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Biopsy Refill Needle
Suzhou Leapmed Healthcare Corporat510(k) NO: K212819(Traditional)
ATTN: Yu  Zhu                     PHONE NO : 86 512 66554498 8043
Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22
Suzhou  CN 215100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Semi Automatic Biopsy Instrument
Suzhou Leapmed Healthcare Corporat510(k) NO: K212820(Traditional)
ATTN: Yu  Zhu                     PHONE NO : 86 512 66554498 8043
Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22
Suzhou  CN 215100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Coaxial Biopsy Needle
Suzhou Leapmed Healthcare Corporat510(k) NO: K212822(Traditional)
ATTN: Yu  Zhu                     PHONE NO : 86 512 66554498 8043
Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22
Suzhou  CN 215100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ers2 - ergoline Rehabilitation System
ergoline GmbH                     510(k) NO: K212883(Traditional)
ATTN: Alexandra  Lertz            PHONE NO : 49 7431 9894138 
Lindenstrasse 5                   SE DECISION MADE: 15-JUL-22
Bitz  DE 72475                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedWand
MedWand Solutions, Inc.           510(k) NO: K212975(Traditional)
ATTN: Robert  Rose                PHONE NO : 844 6339263 
23162 Arroyo Vista                SE DECISION MADE: 22-JUL-22
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medispine - Spinal Needle, Glospine - Spinal Needle
Global Medikit Limited            510(k) NO: K212982(Traditional)
ATTN: Karun  Narang               PHONE NO : 91 112 7667889 
Khasra No 323 MI, Camp Road, SelaqSE DECISION MADE: 29-JUL-22
Dehradun  IN 248197               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cerebra Sleep System
Cerebra Medical Ltd.              510(k) NO: K213007(Traditional)
ATTN: Sharon  Cholowsky           PHONE NO : 1 431 8010332___ 
1470 Wilson Place Unit B          SE DECISION MADE: 06-JUL-22
Winnipeg  CA R3T2N9               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transcranial Doppler Ultrasound System
Shenzhen Delica Medical Equipment 510(k) NO: K213009(Traditional)
ATTN: Zhenhua  Xiao               PHONE NO : 86 755 86210116 
18F, Building B, High-tech park, GSE DECISION MADE: 08-JUL-22
Shenzhen  CN 518107               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LED Facial Mask
Shenzhen OSTO Technology Company L510(k) NO: K213056(Traditional)
ATTN: Li  Yang                    PHONE NO : 86 755 29769546 
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 07-JUL-22
Shenzhen  CN 518100               510(k) STATEMENT
                                                    

DEVICE: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K213060(Traditional)
ATTN: Sally  He                   PHONE NO : 86 25 58646395 
No. 10 Gaoke Third Road, Nanjing NSE DECISION MADE: 20-JUL-22
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Auxilock Titanium Screw-In Suture Anchor
Auxein Medical Private Limited    510(k) NO: K213104(Traditional)
ATTN: Rahul  Luthra               PHONE NO : 91 971 7586969 
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 29-JUL-22
Sonipat  IN 131028                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hemoclip
Hangzhou AGS MedTech Co., Ltd.    510(k) NO: K213143(Traditional)
ATTN: Yanping  Fu                 PHONE NO : 86 571 87671223 
Building 5, Building 6, No. 597 KaSE DECISION MADE: 12-JUL-22
Hangzhou  CN 311106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Berpu Medical Technology Co., Ltd.510(k) NO: K213158(Traditional)
ATTN: David  Yu                   PHONE NO : 86 188 68131179 
No. 14 Xingji Road, Yongxing StreeSE DECISION MADE: 21-JUL-22
Wenzhou  CN 325000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovaCore Semi-Automatic Biopsy Instrument
Argon Medical Devices             510(k) NO: K213232(Traditional)
ATTN: Daniel  Lanois              PHONE NO : 469 7311413 
1445 Flat Creek Road              SE DECISION MADE: 01-JUL-22
Athens TX  75751                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dornier Thulio
DornierMedTech America, Inc       510(k) NO: K213252(Traditional)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts blvd, Suite 100      SE DECISION MADE: 27-JUL-22
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CROSSLEAD Peripheral Guide Wire
Asahi Intecc Co., LTD.            510(k) NO: K213315(Traditional)
ATTN: Tomoya  Eguchi              PHONE NO : 81 561 561859 
3-100 Akatsuki-Cho                SE DECISION MADE: 01-JUL-22
Seto  JP 489-0071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Verily Life Sciences LLC          510(k) NO: K213357(Traditional)
ATTN: Dinesh  Puppala             PHONE NO : 650 2671263 
269 East Grand Avenue             SE DECISION MADE: 19-JUL-22
South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SleepCheckRx
ResApp Health                     510(k) NO: K213360(Traditional)
ATTN: Neroli  Anderson            PHONE NO : 61 416 220239 
Level 12, 100 Creek Street        SE DECISION MADE: 05-JUL-22
Brisbane  AU 4000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEM
Obsidio, Inc.                     510(k) NO: K213385(Traditional)
ATTN: Ehsan  Jabbarzadeh          PHONE NO : 267 2355951 
1520 Main Street, Unit 4-C        SE DECISION MADE: 01-JUL-22
Columbia SC  29201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AltiVate® Anatomic Shoulder AG e+™ with Markers
Encore Medical, L.P.              510(k) NO: K213387(Traditional)
ATTN: Michael  Siano              PHONE NO : 737 2074857 
9800 Metric Boulevard             SE DECISION MADE: 07-JUL-22
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MINE ALNU (Model: Mine 2.1)
HDT Co., Ltd                      510(k) NO: K213405(Traditional)
ATTN: Sung Hee Chun               PHONE NO : 82 624 537752 
# 202-ho, 29, Uchi-ro 880beon-gil,SE DECISION MADE: 10-JUL-22
Gwangju  KR 61042                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZEUS System (Zio Watch)
iRhythm Technologies, Inc.        510(k) NO: K213409(Traditional)
ATTN: Vishal  Kanani              PHONE NO : 213 4000963 
699 8th Street, Suite 600         SE DECISION MADE: 19-JUL-22
San Francisco CA  94103           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGIC Flow-Dependent Microcatheter
Balt USA, LLC                     510(k) NO: K213435(Traditional)
ATTN: Ryan  Kenney                PHONE NO : 949 7881443 
29 Parker                         SE DECISION MADE: 19-JUL-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bladder Scanner, Model Name:M5
Suzhou Peaksonic Medical Technolog510(k) NO: K213488(Traditional)
ATTN: Calvin  Ma                  PHONE NO : 86 512 36693388 
2A, West Side of Building G4, KunsSE DECISION MADE: 01-JUL-22
Suzhou  CN 215341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PELNAC Meshed Bilayer Wound Matrix
Gunze Limited                     510(k) NO: K213498(Traditional)
ATTN: Hidenori  Nishioka          PHONE NO : 81 773 428035 
46 Natsumegaichi, Aono            SE DECISION MADE: 14-JUL-22
Ayabe, Kyoto  JP 623-8513         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AquaA
Fresenius Medical Care Rental Ther510(k) NO: K213507(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 9969103 
920 Winter Street                 SE DECISION MADE: 27-JUL-22
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nihon Kohden NKV-330 Ventilator System
Nihon Kohden OrangeMed, Inc.      510(k) NO: K213521(Traditional)
ATTN: Jacqueline  Villanueva      PHONE NO : 949 5026448 7045
1800 E. Wilshire Avenue           SE DECISION MADE: 01-JUL-22
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Grand Work Plastic Products Co., L510(k) NO: K213574(Traditional)
ATTN: Wu  Yuli                    PHONE NO : 86 311 66766067 
Donggao Industrial Zone, Zanhuang SE DECISION MADE: 12-JUL-22
Shijiazhuang  CN 050000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tatum Surgical Dental Implant System
Suncoast Dental, Inc. dba Tatum Su510(k) NO: K213576(Traditional)
ATTN: Tony  Fiorello              PHONE NO : 1 727 5364880 
4500 140th Avenue North Suite 112 SE DECISION MADE: 15-JUL-22
Clearwater FL  33762              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABMD Software
HeartLung Corporation             510(k) NO: K213760(Traditional)
ATTN: Morteza  Naghavi            PHONE NO : 650 4488089 
1124 W Carson St                  SE DECISION MADE: 29-JUL-22
Torrance CA  90502                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Joule diVa System
Sciton, Inc                       510(k) NO: K213761(Traditional)
ATTN: Jay M Patel                 PHONE NO : 650 5438348 
925 Commercial Street             SE DECISION MADE: 19-JUL-22
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insufflation Retention Device
Bpendo, LLC                       510(k) NO: K213773(Traditional)
ATTN: Robert  Holbrook            PHONE NO : 405 9740776 
216 Foreman Circle                SE DECISION MADE: 21-JUL-22
Norman OK  73069                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single-Use Video Bronchoscopes, Digital Controller
Micro-Tech (Nanjing) Co., Lts     510(k) NO: K213782(Traditional)
ATTN: Sally  He                   PHONE NO : 86 25 58646395 
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 08-JUL-22
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: N Series Patient Monitors
Shenzhen Mindray Bio-medical Elect510(k) NO: K213799(Traditional)
ATTN: Li  Lei                     PHONE NO : 86 755 81885953 
Mindray Building, Keji 12th Road SSE DECISION MADE: 12-JUL-22
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DuraFuse Clip and Applier System
NeuraMedica Inc                   510(k) NO: K213813(Traditional)
ATTN: Rachel  Dreilinger          PHONE NO : 503 9140723 
402 Beavercreek Road, Suite 110   SE DECISION MADE: 22-JUL-22
Oregon City OR  97045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc.     510(k) NO: K213822(Special)
ATTN: Kaitlyn  Hameister          PHONE NO : 925 3680589 
4300 Hacienda Drive               SE DECISION MADE: 06-JUL-22
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
DiaSorin Inc.                     510(k) NO: K213858(Traditional)
ATTN: Christa  Blaisdell          PHONE NO : 651 4399710 
1951 Northwestern Ave             SE DECISION MADE: 26-JUL-22
Stillwater MN  55082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ennovate Cervical Spinal and Occiput System
Aesculap Implant Systems, LLC.    510(k) NO: K213871(Traditional)
ATTN: Paul  Amudala               PHONE NO : 610 4170839 
3773 Corporate Parkway            SE DECISION MADE: 01-JUL-22
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ComPAS2
Morgan Scientific, Inc.           510(k) NO: K213872(Traditional)
ATTN: Deborah  Cornish            PHONE NO : 978 5214440 
151 Essex Street STE 8            SE DECISION MADE: 15-JUL-22
Haverhill MA  01832               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SkyWalker Total Knee System
MicroPort NaviBot International LL510(k) NO: K213873(Traditional)
ATTN: Mike  Manor                 PHONE NO : 508 5610097 
300 Foxborough Blvd.              SE DECISION MADE: 07-JUL-22
Foxborough MA  02035              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity Incubator
STERIS Corporation                510(k) NO: K213881(Traditional)
ATTN: Gregory  Land               PHONE NO : 440 3927424 
5960 Heisley Road                 SE DECISION MADE: 21-JUL-22
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Yeast Caspofungin (<=0.125  - >=8  µg/mL),  VITEK 2 AST-YS Caspofungin (<=0.125  - >=8  µg/mL), VITEK 2 AST-YS Caspofungin
bioMerieux, Inc.                  510(k) NO: K213899(Traditional)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Road                   SE DECISION MADE: 12-JUL-22
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microstream CO2 NanoPod
Covidien LLC                      510(k) NO: K213911(Traditional)
ATTN: Andrew  Berkeland           PHONE NO : 720 5017884 
6135 Gunbarrel Ave                SE DECISION MADE: 29-JUL-22
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Injection Needle
Jiangsu Vedkang Medical Science an510(k) NO: K213914(Traditional)
ATTN: Ting  Tang                  PHONE NO : 86 51969 8777918147 
No. 52, Guoxiang Road, Wujin EconoSE DECISION MADE: 29-JUL-22
Changzhou  CN 213149              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FX SPS
Pixee Medical                     510(k) NO: K213922(Traditional)
ATTN: Agathe  Joet                PHONE NO : 33 4 58101365 
18 rue Alain Savary               SE DECISION MADE: 22-JUL-22
Besancon  FR 25000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON MeMed BV, LIAISON MeMed BV Control Set
DiaSorin Inc.                     510(k) NO: K213936(Traditional)
ATTN: John C. Walter              PHONE NO : 651 4399710 
1951 Northwestern Avenue          SE DECISION MADE: 14-JUL-22
Stillwater MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
Becton, Dickinson and  Company    510(k) NO: K213955(Traditional)
ATTN: Samhitha  Mohan             PHONE NO : 214 9710979 
1 Becton Drive                    SE DECISION MADE: 16-JUL-22
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruAbutment DS, TruBase
TruAbutment Inc.                  510(k) NO: K213961(Traditional)
ATTN: Hyeonhwa  An                PHONE NO : 714 9561488 
17666 Fitch                       SE DECISION MADE: 14-JUL-22
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kontact Dental Implant System
Biotech Dental, SAS               510(k) NO: K213997(Traditional)
ATTN: Delphine  Mercier           PHONE NO : 33 049 0446060 
305, Allées de Craponne           SE DECISION MADE: 15-JUL-22
Salon de Provence  FR 13300       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging Inc 510(k) NO: K213998(Traditional)
ATTN: Sydney  Toutant             PHONE NO : 1 403 2007706 
Suite 1100 - 800 5th Ave SW       SE DECISION MADE: 28-JUL-22
Calgary  CA T2P 3T6               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
Owens & Minor (O&M) Halyard, Inc. 510(k) NO: K214007(Traditional)
ATTN: Anureet  Singh              PHONE NO : 470 4134225 
9120 Lockwood Blvd                SE DECISION MADE: 27-JUL-22
Mechanicsville VA  23116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Examination gloves-Type A(Latex gloves)
Jiangxi Kemei Medical Apparatus & 510(k) NO: K214017(Traditional)
ATTN: Jenny  Huang                PHONE NO : 86 177 02094798 
No. 316 National road, Xinju, ChanSE DECISION MADE: 14-JUL-22
Nanchang  CN 331724               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oscar Peripheral Multifunctional Catheter system
BIOTRONIK, Inc.                   510(k) NO: K214038(Traditional)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 Jean Road                    SE DECISION MADE: 06-JUL-22
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENT Nasopharyngoscope and Accessories
Medimaging Integrated Solution Inc510(k) NO: K214050(Traditional)
ATTN: Jung-Yi  Yen                PHONE NO : 886 357 98860 1706
3F., No.24-2, Industry E. Rd. IV, SE DECISION MADE: 01-JUL-22
Hsinchu  TW 30077                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pentaflush
PENTAFERTE ITALIA S.R.L.          510(k) NO: K214080(Traditional)
ATTN: Rosa  Di Gioia              PHONE NO : 390 86 1560201 
Viale Piane Nocella, 23           SE DECISION MADE: 20-JUL-22
Campli Teramo  IT 64012           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invia Ease Negative Pressure Wound Therapy (NPWT) System
Medela AG                         510(k) NO: K214112(Traditional)
ATTN: Mike  McAndrew              PHONE NO : 1 815 5782376 
Lattichstrasse 4b                 SE DECISION MADE: 26-JUL-22
Baar  CH 6340                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
Becton, Dickinson and Company     510(k) NO: K214122(Traditional)
ATTN: Joseph  Basore              PHONE NO : 616 3014068 
7 Loveton Circle                  SE DECISION MADE: 28-JUL-22
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ChoiceSpine Navigation System
ChoiceSpine, LLC                  510(k) NO: K220024(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433969 
400 Erin Drive                    SE DECISION MADE: 06-JUL-22
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AutoSeg
AI Medic Inc.                     510(k) NO: K220039(Traditional)
ATTN: Jeong Soon Song             PHONE NO : 82 256 82667 
2F, 437, Bongeunsa-ro, Gangnam-gu SE DECISION MADE: 20-JUL-22
Seoul  KR KS013/06097             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
Medos International, SARL         510(k) NO: K220040(Traditional)
ATTN: Michael  Liao               PHONE NO : 925 9998646 
Chemin-Blanc 38                   SE DECISION MADE: 14-JUL-22
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelProcera Zirconia N1 Base
Nobel Biocare Services AG         510(k) NO: K220048(Traditional)
ATTN: Bernice  Jim                PHONE NO : 41 779 8550073 
Balz Zimmermann-Str. 7            SE DECISION MADE: 29-JUL-22
Kloten  CH 8302                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Cytology Brush
Zhejiang Chuangxiang Medical Techn510(k) NO: K220063(Traditional)
ATTN: Lucius  Long                PHONE NO : 86 571 89167088 
Room 101, 201, 301, 401, 501, BuilSE DECISION MADE: 28-JUL-22
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synergy Marble (Model: Opasm)
YRS Group Inc                     510(k) NO: K220064(Traditional)
ATTN: Raphael  Arvili             PHONE NO : 1 702 4268921 
5151 S Procyon St Suite 105       SE DECISION MADE: 22-JUL-22
Las Vegas NV  89118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANNE Sleep
Sibel Inc.                        510(k) NO: K220095(Traditional)
ATTN: Peter  Xu                   PHONE NO : 224 25188590 
6650 W. Touhy Ave.                SE DECISION MADE: 11-JUL-22
Niles IL  60714                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Neuronetics, Inc                  510(k) NO: K220127(Traditional)
ATTN: Cory  Anderson              PHONE NO : 404 4356781 
3222 Phoenixville Pike            SE DECISION MADE: 15-JUL-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biofeedback Nerve and Muscle Stimulator
Shenzhen Konmed Technology Co.,Ltd510(k) NO: K220161(Traditional)
ATTN: ShuiShan  Yin               PHONE NO : 86 136 03046428 
601, Building B4, Shenchengtou CreSE DECISION MADE: 20-JUL-22
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
Northeast Scientific, Inc.        510(k) NO: K220171(Traditional)
ATTN: Matthew  Farley             PHONE NO : 203 7562111 
2142 Thomaston Ave.               SE DECISION MADE: 01-JUL-22
Waterbury CT  06704               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Safety Syringes for Single Use (Retractable)
Shanghai Kindly Enterprise Develop510(k) NO: K220183(Traditional)
ATTN: Liu  Hualong                PHONE NO : 86 691 182328125 
No. 658 Gaochao Road              SE DECISION MADE: 21-JUL-22
Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pump Alignment Syringe
Jiangsu Caina Medical Co., Ltd.   510(k) NO: K220184(Traditional)
ATTN: Jianwei  Pan                PHONE NO : 86 510 86205183 
No.23, Huanxi Road, Zhutang Town  SE DECISION MADE: 21-JUL-22
Jiangyin  CN 214415               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Safety Insulin Syringes for Single Use
Shanghai Kindly Enterprise Develop510(k) NO: K220185(Traditional)
ATTN: Liu  Hualong                PHONE NO : 86 691 182328125 
No. 658 Gaochao Road              SE DECISION MADE: 11-JUL-22
Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Anhui Tiankang Medical Technology 510(k) NO: K220204(Traditional)
ATTN: Zhang  Yong                 PHONE NO : 86 137 05505106 
No.228,Weiyi Road, Economic DeveloSE DECISION MADE: 14-JUL-22
Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C-Stem AMT LE Prosthesis
DePuy Ireland UC                  510(k) NO: K220216(Traditional)
ATTN: Sarah  Matamisa             PHONE NO : 
Loughbeg, Ringaskiddy             SE DECISION MADE: 22-JUL-22
Cork  IE                          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Home use hair removal device
Shenzhen Mareal Tech Co., Ltd     510(k) NO: K220248(Traditional)
ATTN: Liu  Libin                  PHONE NO : 86 755 29980779 
301,Building 1,No.2,Xiashiwei RoadSE DECISION MADE: 01-JUL-22
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
AVIA Vascular                     510(k) NO: K220258(Traditional)
ATTN: Kevin  Cook                 PHONE NO : 801 8245375 
6030 W Harold Gatty Dr.           SE DECISION MADE: 14-JUL-22
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Blue)
KGM Gloves Sdn. Bhd.              510(k) NO: K220284(Traditional)
ATTN: Ooi Loon Seng               PHONE NO : 60 12 4612918 
Lot 18893 & 18894, Jalan PerusahaaSE DECISION MADE: 08-JUL-22
Kamunting  MY 34600               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CerroZone Mobile
CerroZone                         510(k) NO: K220298(Traditional)
ATTN: Marlon E. Robinson          PHONE NO : 
P.O.Box 66800                     SE DECISION MADE: 01-JUL-22
St. Louis MO  63166               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PuraPly Micronized Wound Matrix (PuraPly MZ)
Organogenesis Inc.                510(k) NO: K220317(Traditional)
ATTN: Kurdea  Lyon                PHONE NO : 781 4011063 
150 Dan Road                      SE DECISION MADE: 01-JUL-22
Canton MA  02021                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 091 Balloon Guide Catheter
InNeuroCo Inc.                    510(k) NO: K220331(Traditional)
ATTN: Marc  Litzenberg            PHONE NO : 954 4725988 
19700 Stirling Road, Suite 1      SE DECISION MADE: 29-JUL-22
Pembroke Pines FL  33332          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
Remex Medical Corporation         510(k) NO: K220348(Traditional)
ATTN: Chuang  Shih-Chang          PHONE NO : 886 4 23595336 
4F., No. 9, Jingke Road, Nantun DiSE DECISION MADE: 14-JUL-22
Taichung  TW 408224               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protrieve Sheath
Inari Medical, Inc.               510(k) NO: K220415(Traditional)
ATTN: Kaitlyn  Weinkauf           PHONE NO : 949 4184116 
6001 Oak Canyon, Suite 100        SE DECISION MADE: 12-JUL-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Through the Scope Tracheal Stent System
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K220424(Traditional)
ATTN: Sally  He                   PHONE NO : 86 25 58646395 
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 08-JUL-22
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viz SDH
Viz.ai, Inc.                      510(k) NO: K220439(Traditional)
ATTN: Vi  Ma                      PHONE NO : 626 2363138 
201 Mission St, 12th Floor        SE DECISION MADE: 25-JUL-22
San Francisco CA  94105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
Tianjin Huahong Technology Co., Lt510(k) NO: K220475(Traditional)
ATTN: Yuan  Ying                  PHONE NO : 1 530 2127671 
A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 06-JUL-22
Tianjian  CN 300308               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revogene
Meridian Bioscience, Inc          510(k) NO: K220480(Traditional)
ATTN: Jack  Rogers                PHONE NO : 513 2713700 638
3471 River Hills Drive            SE DECISION MADE: 11-JUL-22
Cincinnati OH  45244              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kentrospine PSS Pedicle Screw System
Rivarp Medical Private Limited    510(k) NO: K220486(Traditional)
ATTN: Sushma  N.R                 PHONE NO : 080 23391136 
No.34, Azeez Sait Industrial Town,SE DECISION MADE: 22-JUL-22
Bangalore  IN 560039              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline
JK-Holding GmbH                   510(k) NO: K220500(Traditional)
ATTN: Juergen  Gerstenmeier       PHONE NO : 49 0 2224818330 
Koehlershohner Strasse 60         SE DECISION MADE: 01-JUL-22
Windhagen  DE 53578               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wet Essential95 Personal Lubricant
Trigg Laboratories, Inc.          510(k) NO: K220534(Traditional)
ATTN: Marla  Bolden               PHONE NO : 702 9574400 
4220 W. Windmill Ln. Suite 140    SE DECISION MADE: 07-JUL-22
Las Vegas NV  89139               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DolorClast Radial
EMS Electro Medical Systems SA    510(k) NO: K220538(Traditional)
ATTN: Timothée  Deblock           PHONE NO : 41 22 9948516 
Ch. de la Vuarpilliere 31         SE DECISION MADE: 11-JUL-22
Nyon  CH 1260                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dermatac Drape
3M                                510(k) NO: K220560(Traditional)
ATTN: Melanie  Avila              PHONE NO : 210 2755038 
6203 Farinon Drive                SE DECISION MADE: 14-JUL-22
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vascette HP (hemostatic pad)
KOAG LLC                          510(k) NO: K220566(Traditional)
ATTN: David  Lang                 PHONE NO : 470 7559291 
790 Rarity Bay Pkwy               SE DECISION MADE: 29-JUL-22
Vonore TN  37885                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Noodle
Pourang Bral, DDS, LLC            510(k) NO: K220573(Traditional)
ATTN: Pourang  Bral               PHONE NO : 201 2644862 
155 Albion Street                 SE DECISION MADE: 09-JUL-22
Passaic NJ  07055                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Handpiece, Model CA160, CA160L, and CA500L
Micro-NX Co., Ltd.                510(k) NO: K220577(Traditional)
ATTN: Sojeong  Park               PHONE NO : 82 05 36501000 
22 Maeyeo-ro 1 gil                SE DECISION MADE: 29-JUL-22
Dong-gu  KR 41059                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
Ambu A/S                          510(k) NO: K220606(Traditional)
ATTN: Gurpreet Kaur Rehal         PHONE NO : 45 266 08888 
Baltorpbakken 13                  SE DECISION MADE: 25-JUL-22
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and 510(k) NO: K220619(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
LLC 9900 W. Innovation Drive      SE DECISION MADE: 15-JUL-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hailie Sensor NF0106
Adherium (NZ) Ltd                 510(k) NO: K220622(Traditional)
ATTN: Geoff  Feakes               PHONE NO : 64 9 3072771 
Level 11, 16 Kingston Street      SE DECISION MADE: 15-JUL-22
Auckland  NZ 1010                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI4CMR v1.0
AI4MedImaging Medical Solutions S.510(k) NO: K220624(Traditional)
ATTN: Carla  Almeida              PHONE NO : 93 507 7566 
Rua do Parque Poente, Lote 35     SE DECISION MADE: 22-JUL-22
Braga  PT 4705-002                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NomadAir PMU810
Neurotronics, Inc.                510(k) NO: K220631(Traditional)
ATTN: James "Cody"  Smith         PHONE NO : 352 3729955 
4500 NW 27th Ave STE C2           SE DECISION MADE: 15-JUL-22
Gainesville FL  32606             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
HTL-Strefa S.A.                   510(k) NO: K220643(Traditional)
ATTN: Justyna  Zemigala           PHONE NO : 48 42 2700010 
Adamowek 7                        SE DECISION MADE: 08-JUL-22
Ozorkow  PL 95-035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prevena Restor Adapti-Form Dressing
3M Health Care Business Group     510(k) NO: K220660(Traditional)
ATTN: Teri  Feeley                PHONE NO : 210 4591952 
6203 Farinon Dr.                  SE DECISION MADE: 01-JUL-22
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Manual Wheelchair
Hebei Ruilangde Medical Equipment 510(k) NO: K220671(Traditional)
ATTN: Liu  Zhihao                 PHONE NO : 86 134 75165790 
Zhongkuang S. Rd., High-tech DevelSE DECISION MADE: 21-JUL-22
Hengshui  CN 053599               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pediatric Nailing Platform | Femur
OrthoPediatrics Corp.             510(k) NO: K220679(Traditional)
ATTN: Yan  Li                     PHONE NO : 574 2670864 
2850 Frontier Drive               SE DECISION MADE: 20-JUL-22
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiVu ROSA MxR
Orthosoft, Inc. (d/b/a Zimmer CAS)510(k) NO: K220733(Traditional)
ATTN: Paul  Hardy                 PHONE NO : 574 4536739 
75 Queen St., Suite 3300          SE DECISION MADE: 29-JUL-22
Montreal  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NxtGen Infant Transport Incubator
International Biomedical          510(k) NO: K220742(Traditional)
ATTN: Amy  Pieper                 PHONE NO : 512 8730033 
8206 Cross Park Drive             SE DECISION MADE: 15-JUL-22
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CediTEC
VOCO GmbH                         510(k) NO: K220743(Traditional)
ATTN: M. Th. Plaumann             PHONE NO : 49 4721 7190 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 05-JUL-22
Cuxhaven  DE 27472                510(k) STATEMENT
                                                    

DEVICE: Stratasys TrueDent
Stratasys Ltd                     510(k) NO: K220771(Traditional)
ATTN: Melanie  Glennon            PHONE NO : 972 74 7454000 
1 Holtzman St. Science Park P.O. BSE DECISION MADE: 07-JUL-22
Rehovot  IL 7612401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical face mask
Hubei Qianjiang Kingphar Medical M510(k) NO: K220777(Traditional)
ATTN: Zhao  Fusong                PHONE NO : 86 133 49716939 
Yuanguang Road                    SE DECISION MADE: 19-JUL-22
Qianjiang  CN 433100              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.              510(k) NO: K220784(Traditional)
ATTN: Sindhu  Sridhar             PHONE NO : 1 442 9997630___ 
2210 Faraday Ave, Suite 100       SE DECISION MADE: 01-JUL-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tigertriever 13 Revascularization Device
Rapid Medical Ltd.                510(k) NO: K220808(Traditional)
ATTN: Orit  Yaniv                 PHONE NO : 972 72 2503331___ 
Carmel Building, POB 337          SE DECISION MADE: 25-JUL-22
Yokneam  IL 2069205               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAEOTOM Alpha, Scan&GO Software
Siemens Medical Solutions USA, Inc510(k) NO: K220814(Traditional)
ATTN: Tabitha  Estes              PHONE NO : 865 8044553 
810 Innovation Drive              SE DECISION MADE: 12-JUL-22
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrainInsight
Hyperfine, Inc.                   510(k) NO: K220815(Traditional)
ATTN: Christine  Kupchick         PHONE NO : 203 3433404 
351 New Whitfield St              SE DECISION MADE: 19-JUL-22
Guilford CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
American Nitrile Operations LLC   510(k) NO: K220825(Abbreviated)
ATTN: Stephen  Perrin             PHONE NO : 937 9645559 
3500 Southwest Blvd               SE DECISION MADE: 08-JUL-22
Grove City OH  43123              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Wheelchair
Foshan Dahao Medical Technology  C510(k) NO: K220827(Traditional)
ATTN: Bao Yi Xie                  PHONE NO : 86 137 60674304 
Building 1, 2nd Floor of Building SE DECISION MADE: 05-JUL-22
Foshan  CN 528137                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-GPS Navigated Instruments
Precision Spine, Inc.             510(k) NO: K220862(Traditional)
ATTN: Michael  Dawson             PHONE NO : 601 4204244 
2050 Executive Dr.                SE DECISION MADE: 14-JUL-22
Pearl MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AOK 95A Medical Mask (20200049)
AOK Tooling Limited               510(k) NO: K220876(Traditional)
ATTN: Francis  Nithyananthan      PHONE NO : 852 0 23101703 
Flat 2009, 20/F, Kowloon Plaza, NoSE DECISION MADE: 27-JUL-22
Cheung Sha Wan, Kowloon  CN 518122510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
Lumenis Be, Inc.                  510(k) NO: K220877(Traditional)
ATTN: Shlomit  Segman             PHONE NO : 972 4 9599230 
1870 South Milestone Drive        SE DECISION MADE: 15-JUL-22
Salt Lake City UT  84104          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and 510(k) NO: K220882(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
Primary Care Diagnostics, LLC 9900SE DECISION MADE: 22-JUL-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upper Arm Type  Blood Pressure Monitor
Shenzhen Jamr Technology Co.,Ltd  510(k) NO: K220886(Traditional)
ATTN: Luo  Fusheng                PHONE NO : 86 755 85292057 
A101-301,D101-201, Jamr Science & SE DECISION MADE: 27-JUL-22
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S-Core Implant System
Subchondral Solutions, Inc.       510(k) NO: K220901(Traditional)
ATTN: Michael  Kolber             PHONE NO : 408 5056626 
7146 Edinger Ave. Suite A         SE DECISION MADE: 29-JUL-22
Huntington Beach CA  92647        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SECURE-LOCK
Xiros Ltd                         510(k) NO: K220906(Traditional)
ATTN: Steve  Curran               PHONE NO : 44 113 2387200 
Springfield House Lane, WhitehouseSE DECISION MADE: 22-JUL-22
Leeds  GB LS17 7UE                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
Cochlear Americas                 510(k) NO: K220922(Traditional)
ATTN: Samata  Veluvolu            PHONE NO : 302 5426468 
10350 Park Meadows Drive          SE DECISION MADE: 27-JUL-22
Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and 510(k) NO: K220940(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
LLC 9900 W. Innovation Drive      SE DECISION MADE: 22-JUL-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
ECO Medi Glove Sdn.Bhd.           510(k) NO: K220943(Traditional)
ATTN: Suresh  Kumar               PHONE NO : 605 8062316 
Lot 23826, Jalan Tembaga Kuning, KSE DECISION MADE: 19-JUL-22
Taiping  MY 34600                 510(k) STATEMENT
                                                    

DEVICE: Libby Echo:Prio
Dyad Medical, Inc                 510(k) NO: K220956(Traditional)
ATTN: Ronny  Shalev               PHONE NO : 617 4809569 
215 Brighton Avenue, Suite 203    SE DECISION MADE: 20-JUL-22
Boston MA  02134                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Real Intelligence Cori
Blue Belt Technologies, Inc.      510(k) NO: K220958(Traditional)
ATTN: Unnati  Bhuptani            PHONE NO : 412 8536682 
2905 Northwest Blvd., Ste. 40     SE DECISION MADE: 27-JUL-22
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deep Learning Image Reconstruction
GE Healthcare Japan Corporation   510(k) NO: K220961(Special)
ATTN: Wang  Xing                  PHONE NO : 86 10 57388271 
7-127, 4-Chome, Asahigaoka        SE DECISION MADE: 29-JUL-22
Hino  JP 191-8503                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renuvion APR Handpiece
Apyx Medical Corporation(formerly 510(k) NO: K220970(Traditional)
ATTN: Priscilla  Herpai           PHONE NO : 610 5337984 
5115 Ulmerton Road                SE DECISION MADE: 15-JUL-22
Clearwater FL  33760-4004         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Life Scope PT BSM-1700 Series Bedside Monitor
Nihon Kohden Corporation          510(k) NO: K220976(Special)
ATTN: Sandra  Gadeyne             PHONE NO : 949 3563401 
1-31-4 Nishiochiai, Shinjuki-Ku   SE DECISION MADE: 21-JUL-22
Tokyo  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Next Generation NetKonnect
Nihon Kohden Digital Health Soluti510(k) NO: K220989(Special)
ATTN: Maria  Pronina              PHONE NO : 949 5919596 
14 Bunsen                         SE DECISION MADE: 29-JUL-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Osteon Precision Milled Suprastructure
Implant Solutions PTY LTD (aka Ost510(k) NO: K221019(Traditional)
ATTN: Andrea Del Ciotto           PHONE NO : 61 408 583222 
759-767 Springvale Road           SE DECISION MADE: 05-JUL-22
Mulgrave  AU 3170                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
MRI Division,Beijing Wandong Medic510(k) NO: K221025(Traditional)
ATTN: Wang  Huan                  PHONE NO : 86 10 65794660 
No.38, Chaoyang Road, Chaoyang DisSE DECISION MADE: 01-JUL-22
Beijing  CN 100024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Power Wheelchair
Zhejiang Innuovo Rehabilitation De510(k) NO: K221026(Traditional)
ATTN: Leo  Zheng                  PHONE NO : 86 183 58936043 
No.196 Industry Road, Hengdian MovSE DECISION MADE: 01-JUL-22
Dongyang  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SURGIVISIO Device
Ecential Robotics                 510(k) NO: K221028(Traditional)
ATTN: Sarah  Lefevre-Billard      PHONE NO : 0033 4 58005721 
Zone Mayencin II, Parc Equation - SE DECISION MADE: 06-JUL-22
Gieres  FR 38610                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Model 9100 PFT/DICO
Vitalograph Ireland Ltd.          510(k) NO: K221030(Traditional)
ATTN: Tony  O'Hanlon              PHONE NO : 353 65 6864100 
Gort Road Business Park           SE DECISION MADE: 15-JUL-22
Ennis Co Clare  IE V95 HFT4       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UniPrime A, UniPrime E, UniPrime E/C
S&C Polymer Silicon- und Composite510(k) NO: K221033(Traditional)
ATTN: Christian  Böttcher         PHONE NO : 49 4121 4830 
Robert-Bosch-Str. 2               SE DECISION MADE: 06-JUL-22
Elmshorn  DE 25335                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astroglide Warming
BioFilm Inc.                      510(k) NO: K221036(Traditional)
ATTN: Kevin  Jamil                PHONE NO : 760 7279030 
3225 Executive Ridge              SE DECISION MADE: 01-JUL-22
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruDi Shaver Blade
Acclarent, Inc.                   510(k) NO: K221037(Traditional)
ATTN: Leena  Zalavadia            PHONE NO : 1 949 9234118 
31 Technology Drive, Suite 200    SE DECISION MADE: 20-JUL-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Changsha Honchon Technology Co., L510(k) NO: K221051(Traditional)
ATTN: Ling  Li                    PHONE NO : 86 731 85529297 
Room 627-628, Building 3th, JinqiaSE DECISION MADE: 08-JUL-22
Changsha  CN 410200               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smartlux Mini
MEDMIX Co., Ltd.                  510(k) NO: K221083(Traditional)
ATTN: Yunseok  Yu                 PHONE NO : 82 10 94878160 
B-707 Smartvalley, 30, SongdomiraeSE DECISION MADE: 12-JUL-22
Incheon  KR 21990                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmileSeries
Ordont Orthodontic Laboratories, I510(k) NO: K221097(Traditional)
ATTN: Paul  Rudzicka              PHONE NO : 800 3253698 
1755 Smizer Station Road          SE DECISION MADE: 14-JUL-22
Fenton MO  63026                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Stryker Corporation               510(k) NO: K221098(Traditional)
ATTN: Maya  Schiel                PHONE NO : 49 30 31199189 
Boetzinger Strasse 41             SE DECISION MADE: 12-JUL-22
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Medical  Examination Gloves
Anhui Fulewei Electronic Technolog510(k) NO: K221108(Traditional)
ATTN: Beina  Gong                 PHONE NO : 86 1505 5553699 
South Of Binheroad, West Of GangkoSE DECISION MADE: 12-JUL-22
Fuyang  CN 236000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid T8, Vivid T9
GE Medical Systems Ultrasound and 510(k) NO: K221147(Traditional)
ATTN: Lee  Bush                   PHONE NO : 262 3099429 
LLC 9900 W. Innovation Drive      SE DECISION MADE: 18-JUL-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid iq
GE Medical Systems Ultrasound & Pr510(k) NO: K221148(Traditional)
ATTN: Lee  Bush                   PHONE NO : 262 3099429 
9900 W. Innovation Drive          SE DECISION MADE: 18-JUL-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beauty LED Mask, Model: KFB265
Hunan Guangye Biotechnology Co., L510(k) NO: K221151(Traditional)
ATTN: Eileen  Li                  PHONE NO : 86 0755 89373426 
Room 701, Jinhong Park Incubation SE DECISION MADE: 19-JUL-22
Changsha City  CN 410006          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask (Model: 0868F, 0866F)
Jiangxi SanHao Medical Instruments510(k) NO: K221173(Traditional)
ATTN: Jiali  Chen                 PHONE NO : 86 151 79660192 
Chengxi Industrial Park, Jishui CoSE DECISION MADE: 06-JUL-22
Ji'an  CN 331699                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insulin Pen Needle
Tianjin Huahong Technology Co., Lt510(k) NO: K221176(Special)
ATTN: Yuan  Ying                  PHONE NO : 1 530 2127671 
A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 01-JUL-22
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Face Mask (ear loop)
Xiantao Topmed Nonwoven Protective510(k) NO: K221196(Traditional)
ATTN: Vivian  Zhu                 PHONE NO : 86 2787 861070 
North of the National Road 318, ToSE DECISION MADE: 22-JUL-22
Xiantao  CN 433000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AHI System
Fifth Eye Inc.                    510(k) NO: K221203(Special)
ATTN: Jennifer  Baird             PHONE NO : 734 2604800 
110 Miller Avenue, Suite 300      SE DECISION MADE: 14-JUL-22
Ann Arbor MI  48104               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
Zibo Blue Sail Health Technology C510(k) NO: K221229(Traditional)
ATTN: Xu  Shulong                 PHONE NO : 0086 533 7859085 
No.1888 Honghua Road, High TechnicSE DECISION MADE: 16-JUL-22
Zibo  CN 255400                   510(k) STATEMENT
                                                    

DEVICE: TRON
Xoran Technologies LLC            510(k) NO: K221230(Traditional)
ATTN: Mark  McGarrow              PHONE NO : 734 4185125 
5210 S. State Rd.                 SE DECISION MADE: 28-JUL-22
Ann Arbor MI  48108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TargetCool
RecensMedical Inc.                510(k) NO: K221234(Traditional)
ATTN: Yeonui  Lee                 PHONE NO : 82 31 80433064__ 
908, SK V1 center, 830 DongtansunhSE DECISION MADE: 22-JUL-22
Hwaseong-si  KR 18468             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: neXus Ultrasonic Surgical Aspirator System
Misonix Inc.                      510(k) NO: K221235(Traditional)
ATTN: John  Salerno               PHONE NO : 1 631 6949555 
1938 New Highway                  SE DECISION MADE: 28-JUL-22
Farmingdale NY  11735             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Hunan Vsmile Biotechnology Co., Lt510(k) NO: K221242(Traditional)
ATTN: Xiaomi  Tang                PHONE NO : 86 731 85682958 
Juxing 501-5,501-6, Lujing Road NoSE DECISION MADE: 29-JUL-22
Changsha  CN 410000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
Shenzhen Semlamp Intelligent Techn510(k) NO: K221246(Traditional)
ATTN: Qi  Wenjun                  PHONE NO : 86 1342 8733261 
Room 915, Lankun Building, MinkangSE DECISION MADE: 07-JUL-22
Shenzhen  CN 518131               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
Guangzhou Hua Kai Electronic Techn510(k) NO: K221251(Traditional)
ATTN: Cao  Ke                     PHONE NO : 86 020 82061985 
4th Floor, Building 8, No.39 Bi GaSE DECISION MADE: 29-JUL-22
Guangzhou  CN 510730              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hummingbird Tympanostomy Tube System
Preceptis Medical, Inc.           510(k) NO: K221254(Traditional)
ATTN: Steve  Anderson             PHONE NO : 763 5687809 
10900 89th Avenue North, Suite 4  SE DECISION MADE: 27-JUL-22
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
Dexcom, Inc.                      510(k) NO: K221259(Special)
ATTN: Rachel  Ellena              PHONE NO : 858 2036046 
6340 Sequence Dr.                 SE DECISION MADE: 29-JUL-22
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co.510(k) NO: K221269(Traditional)
ATTN: Zhu  Chunyan                PHONE NO : 86 311 66766067 
Fuqian Xi Road, West district of SSE DECISION MADE: 27-JUL-22
Shenze County  CN 050000          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Shandong Maida Medical Technology 510(k) NO: K221271(Traditional)
ATTN: Kitty  Xu                   PHONE NO : 86 1385 3370291 
Room 102, Eastern building, No.166SE DECISION MADE: 27-JUL-22
Dongying  CN 257000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-Brik Visualization Assistant
JDI Surgical, Inc.                510(k) NO: K221293(Traditional)
ATTN: Dwight  Lenox               PHONE NO : 720 3713071 
9925 Silver Maple Way             SE DECISION MADE: 07-JUL-22
Highlands Ranch CO  80129         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoCentric Spine MIS Pedicle Fastener System
OsteoCentric Technologies         510(k) NO: K221332(Traditional)
ATTN: Todd  Evans                 PHONE NO : 435 7572253 
75 West 300 N, Suite 150          SE DECISION MADE: 28-JUL-22
Logan UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Materialise TKA Guide System
Materialise NV                    510(k) NO: K221337(Traditional)
ATTN: Jenny  Jones                PHONE NO : 32 16 396611 
Technologielaan 15                SE DECISION MADE: 05-JUL-22
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker VariAx 2 MIS Calcaneus
Stryker GmbH                      510(k) NO: K221346(Traditional)
ATTN: Jonathan  Schell            PHONE NO : 484 8895804 
325 Corporate Drive               SE DECISION MADE: 08-JUL-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AF Laser
ShenB Co Ltd                      510(k) NO: K221363(Traditional)
ATTN: Sunny  Kang                 PHONE NO : 82 70 49122702 
ShenB Bldg 148 Seongsui-ro        SE DECISION MADE: 20-JUL-22
Seoul  KR 04796                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mitek TIGHT-N Anchor
Medos International SARL          510(k) NO: K221364(Traditional)
ATTN: Ashley  Aromando (Goncalo)  PHONE NO : 508 9773907 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 11-JUL-22
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 14HQ701G-B
LG Electronics Inc.               510(k) NO: K221394(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
77, Sanho-daero                   SE DECISION MADE: 22-JUL-22
Gumi-si  KR 39381                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Footmotion Plating System
Newclip Technics                  510(k) NO: K221395(Traditional)
ATTN: Gaëlle  Lussori             PHONE NO : 33 228 213712 
P.A. de la Lande Saint Martin - 45SE DECISION MADE: 01-JUL-22
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIP™ MIS Interspinous Fusion System
Aurora Spine, Inc.                510(k) NO: K221399(Traditional)
ATTN: Laszlo  Garamszegi          PHONE NO : 760 4242004 
1930 Palomar Point Way, Suite #103SE DECISION MADE: 08-JUL-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Conformis Inc.                    510(k) NO: K221404(Traditional)
ATTN: Mary  Kruitwagen            PHONE NO : 781 3459038 
600 Technology Park Drive, 4th FloSE DECISION MADE: 26-JUL-22
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truSculpt iD
Cutera Inc.                       510(k) NO: K221407(Traditional)
ATTN: Amogh  Kothare              PHONE NO : 415 6906796 
3240 Bayshore Blvd.               SE DECISION MADE: 13-JUL-22
Brisbane CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paneffort 3-ply Surgical and Procedural Masks
Paneffort, LLC                    510(k) NO: K221409(Traditional)
ATTN: Harry  No Last Name ProvidedPHONE NO : 855 12284810 
700 Elmridge Center Drive         SE DECISION MADE: 25-JUL-22
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Functional MR V1.0
Olea Medical SAS                  510(k) NO: K221426(Traditional)
ATTN: Nathalie  Palumbo           PHONE NO : 33 4 42712420 
93 Avenue des Sorbiersm ZI ATHELIASE DECISION MADE: 06-JUL-22
La Ciotat  FR 13600               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KDF Zirconia Disc
DENKEN-HIGHDENTAL Co., Ltd.       510(k) NO: K221429(Traditional)
ATTN: Daijiro  Goto               PHONE NO : 81 75 6722124 
24-3                              SE DECISION MADE: 14-JUL-22
Kisshoin Ishiharakyomichi-cho, Min510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: reVive Light Therapy LED Cleansing System
LED Technologies, Inc.            510(k) NO: K221430(Special)
ATTN: Jelena  Barbaric            PHONE NO : 303 8450028 
12821 Starkey Rd., Suite 4900     SE DECISION MADE: 27-JUL-22
Largo FL  33773                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
Church & Dwight Co., Inc.         510(k) NO: K221431(Traditional)
ATTN: Supreet  Sahota-Bhatti      PHONE NO : 609 8067893 
500 Charles Ewing Blvd.           SE DECISION MADE: 14-JUL-22
Ewing NJ  08628                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Facet 28G Universal Lancet
Facet Technologies LLC            510(k) NO: K221433(Traditional)
ATTN: James  Bonds                PHONE NO : 770 5906462 
3900 N. Commerce Dr.              SE DECISION MADE: 15-JUL-22
Atlanta GA  30344                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 17HQ701G-B
LG Electronics Inc.               510(k) NO: K221434(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
77, Sanho-daero                   SE DECISION MADE: 13-JUL-22
Gumi-si  KR 39381                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Examination Gloves - Non Sterile
Guangzhou Kangling Biotechnology C510(k) NO: K221454(Traditional)
ATTN: Yan  Wang                   PHONE NO : 86 208 7866619 
Baiyun Avenue,Yongping Street,BaiySE DECISION MADE: 12-JUL-22
Guangzhou  CN 510440              510(k) STATEMENT
                                                    

DEVICE: BioFire COVID-19 Test 2
BioFire Defense, LLC              510(k) NO: K221460(Special)
ATTN: Cynthia  Phillips           PHONE NO : 801 2623592 1370
79 W 4500 S, Suite 14             SE DECISION MADE: 25-JUL-22
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 10HQ701G-B
LG Electronics Inc.               510(k) NO: K221461(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
77, Sanho-daero                   SE DECISION MADE: 22-JUL-22
Gumi-si  KR 39381                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorPath GRX System
Corindus, Inc.                    510(k) NO: K221464(Special)
ATTN: Robert  Lavado              PHONE NO : 978 7607727 
309 Waverley Oaks Road, Suite 105 SE DECISION MADE: 27-JUL-22
Waltham MA  02452                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus Synd-EZ SS
Parcus Medical, LLC               510(k) NO: K221502(Traditional)
ATTN: Vasavi  Vora                PHONE NO : 
6423 Parkland Drive               SE DECISION MADE: 26-JUL-22
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
Vieworks Co., Ltd.                510(k) NO: K221512(Traditional)
ATTN: Kevin  Oh                   PHONE NO : 82 70 44663220 
41-3, Burim-ro 170beon-gil, DonganSE DECISION MADE: 20-JUL-22
Anyang-si  KR 14055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTIS icono (Ceiling Configuration)
Siemens Medical Solutions USA, Inc510(k) NO: K221516(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 678 5758832 
40 Liberty Boulevard              SE DECISION MADE: 19-JUL-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PreXion3D Explorer PRO
PreXion Corporation               510(k) NO: K221525(Traditional)
ATTN: Hiroaki  Takahashi          PHONE NO : 81 3 52977551 
1-14-1, Kandasuda-cho             SE DECISION MADE: 22-JUL-22
Chiyoda-ku  JP 101-0041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Align Lumbar Interbody Fusion System
Acuity Surgical Devices, LLC      510(k) NO: K221535(Traditional)
ATTN: Bryan  Cowan                PHONE NO : 844 2284890 
8710 N. Royal Lane                SE DECISION MADE: 22-JUL-22
Irving TX  75063                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
Qingdao Hisense Medical Equipment 510(k) NO: K221567(Traditional)
ATTN: Li  Mingcheng               PHONE NO : 86 532 83091111 
No. 399 Songling Road, Laoshan DisSE DECISION MADE: 26-JUL-22
Qingdao  CN 266100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VyPlate Anterior Cervical Plate System
Vy Spine, LLC                     510(k) NO: K221572(Traditional)
ATTN: Jordan  Hendrickson         PHONE NO : 866 4897746 
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 26-JUL-22
Tallahassee FL  32308             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2-Way 100% Silicone ClearTract Catheter
Silq Technologies Corporation     510(k) NO: K221625(Special)
ATTN: Sigi  Caron                 PHONE NO : 831 3466970 
323 Sunny Isles Blvd              SE DECISION MADE: 01-JUL-22
Sunny Isles Beach FL  33160       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: medi pneumatic compression system (pcs)-genius (Model 652)
medi USA, L.P.                    510(k) NO: K221654(Third Party - Traditional)
ATTN: Moses  Lipshaw              PHONE NO : 336 4494440 229
6481 Franz Warner Parkway         SE DECISION MADE: 07-JUL-22
Whitsett NC  27377-9214           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Normatec Go
NormaTec Industries, LP           510(k) NO: K221666(Third Party - Traditional)
ATTN: Steve  Henderson            PHONE NO : 800 3350906 
480 Pleasant Street, Suite A200   SE DECISION MADE: 14-JUL-22
Watertown MA  02472               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IPL Hair Remover, Model: G993, G996, G998 and G885
Shenzhen Mywin Technology Co., Ltd510(k) NO: K221679(Special)
ATTN: Meiyun  Liu                 PHONE NO : 86 18902 842323 
2nd Floor, Building B, New Age gonSE DECISION MADE: 07-JUL-22
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pegasus-X Expandable PLIF System
GS Medical Co. Ltd.               510(k) NO: K221687(Traditional)
ATTN: Sam  Camp                   PHONE NO : 352 3274641 
90, Osongsaengmyeong 4-ro Osong-euSE DECISION MADE: 27-JUL-22
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc510(k) NO: K221727(Special)
ATTN: Monsuru  Bello              PHONE NO : 202 8566099 
810 innovation Drive              SE DECISION MADE: 13-JUL-22
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation  510(k) NO: K221763(Special)
ATTN: Alexandra  Wells            PHONE NO : 609 9036300 
1100 Campus Rd                    SE DECISION MADE: 15-JUL-22
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
ONETEXX SDN BHD                   510(k) NO: K221773(Traditional)
ATTN: Freddy  Low                 PHONE NO : 605  8070666 
No 73-86, JLN Logam 5, PerindustriSE DECISION MADE: 30-JUL-22
Kamunting  MY 34600               510(k) STATEMENT
                                                    

DEVICE: Vario-Cup System
Waldemar Link GmbH & Co. KG       510(k) NO: K221794(Special)
ATTN: Pia  Mueller                PHONE NO : 49 40 53575530 
Oststraße 4-10                    SE DECISION MADE: 20-JUL-22
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
SEDECAL SA                        510(k) NO: K221803(Special)
ATTN: Ma Luisa  Gomez de Aguero   PHONE NO : 34 91 6280544 
C/ Pelaya, 9 – 13 Pol. Ind. Río deSE DECISION MADE: 18-JUL-22
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OK Handpiece
Jaintek Co.,Ltd                   510(k) NO: K221814(Third Party - Traditional)
ATTN: Jung Gun Lee                PHONE NO : 82 31 4959091 
#302, 419, Byeolmang-ro, Danwon-guSE DECISION MADE: 15-JUL-22
Ansan-si  KR 15605                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Cionic Neural Sleeve NS-100
CIONIC                            510(k) NO: K221823(Special)
ATTN: Mihai  Ionescu              PHONE NO : 1 831 8244051 
1606 Stockton St, Suite #1        SE DECISION MADE: 21-JUL-22
San Francisco CA  94133           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Artix Ballon Guiding Sheath
Inari Medical                     510(k) NO: K221846(Third Party - Traditional)
ATTN: Elllen  Nguyen              PHONE NO : 949 4184127 
6001 Oak Canyon Suite 100         SE DECISION MADE: 11-JUL-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OTC DDR
Konica Minolta Healthcare Americas510(k) NO: K221853(Special)
ATTN: Jan  Maniscalco             PHONE NO : 973 6331500 
2217 US Highway 70 East           SE DECISION MADE: 27-JUL-22
Garner NC  27529                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOMONITOR IIIm, BIOMONITOR III
BIOTRONIK, Inc.                   510(k) NO: K221856(Special)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 Jean Road                    SE DECISION MADE: 27-JUL-22
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Radiography CXDI-Pro, Digital Radiography D1
Canon Inc.                        510(k) NO: K221876(Special)
ATTN: Akira  Hirai                PHONE NO : 81 33 7582111 
9-1 Imaikami-cho, Nakahara-ku,    SE DECISION MADE: 15-JUL-22
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-Free Nitrile Examination Glove, Non-Sterile
GoodGloves Industries Sdn Bhd     510(k) NO: K221877(Third Party - Traditional)
ATTN: Yee  Kam Lin                PHONE NO : 
PT 12678, Jalan Techvalley 2, SendSE DECISION MADE: 23-JUL-22
Seremban  MY 71950                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Gastrointestinal Boundary Identifier (GIBI HD)
ReShape Lifesciences              510(k) NO: K221898(Special)
ATTN: Michelle  Ravert            PHONE NO : 949 4817851 
1001 Calle Amanecer               SE DECISION MADE: 28-JUL-22
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EleGARD
AdvancedCPR Solutions LLC         510(k) NO: K221901(Special)
ATTN: Philip  Faris               PHONE NO : 210 5086647 
5201 Eden Avenue Suite 300        SE DECISION MADE: 29-JUL-22
Edina MN  55436                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INERTIA CONNEXX Modular Pedicle Screw System
Nexxt Spine LLC                   510(k) NO: K221905(Special)
ATTN: Andy  Elsbury               PHONE NO : 317 4367801 
14425 Bergen Blvd Suite B         SE DECISION MADE: 28-JUL-22
Noblesville IN  46060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RhinAer® Stylus (FG1393)
Aerin Medical Inc.                510(k) NO: K221907(Special)
ATTN: Shannon  Scott              PHONE NO : 512 2219956 
2565 Leghorn St.                  SE DECISION MADE: 29-JUL-22
Mountain View CA  91043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: J-Temp
Ultradent Products, Inc.          510(k) NO: K221909(Third Party - Traditional)
ATTN: Matthew  Buck               PHONE NO : 801 5534339 
505 W Ultradent Drive (10200 SouthSE DECISION MADE: 01-JUL-22
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Catapult Guide Sheath
Contract Medical International Gmb510(k) NO: K221914(Special)
ATTN: Juliana  Vaz Nuernberger    PHONE NO : 49 351 21074719 
Lauensteiner Strasse 37           SE DECISION MADE: 29-JUL-22
Dresden  DE 01277                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trinias
Shimadzu Corporation Medical Syste510(k) NO: K221922(Special)
ATTN: Koichi  Kataoka             PHONE NO : 81 75 8231305 
1, Nishinokyo-Kuwabaracho, NakagyoSE DECISION MADE: 28-JUL-22
Kyoto  JP 604-8511                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swoop Portable MR Imaging System
Hyperfine, Inc.                   510(k) NO: K221923(Special)
ATTN: Christine  Kupchick         PHONE NO : 203 3433404 
351 New Whitfield Street          SE DECISION MADE: 28-JUL-22
Guilford CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cemented Round Patella with JRNY Pegs
Smith & Nephew, Inc.              510(k) NO: K221939(Special)
ATTN: Madison  Padgett            PHONE NO : 901 4568789 
7135 Goodlett Farms Parkway       SE DECISION MADE: 26-JUL-22
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm
Conmed Corporation                510(k) NO: K221945(Special)
ATTN: Kavita  Amin                PHONE NO : 508 9482084 
11311 Concept Blvd                SE DECISION MADE: 28-JUL-22
Largo FL  33773                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXALT Model B Single-Use Bronchoscope
Boston Scientific Corporation     510(k) NO: K222014(Special)
ATTN: Carter  Navarro             PHONE NO : 508 3820356 
100 Boston Scientific Way         SE DECISION MADE: 28-JUL-22
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biotres
Biotricity                        510(k) NO: K222017(Special)
ATTN: Spencer  LaDow              PHONE NO : 585 4147407 
203 Redwood Shores Pkwy Suite 600 SE DECISION MADE: 28-JUL-22
Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Selectra Lead Implantation System
Biotronik, Inc.                   510(k) NO: K222037(Special)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 Jean Road                    SE DECISION MADE: 19-JUL-22
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA


          TOTAL 510(k)s THIS PERIOD   257                                     
          TOTAL WITH SUMMARIES        251                                     
          TOTAL WITH STATEMENTS        6
 
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