Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

HWC 2022-04-13

Cannulated Compression Device System

Applicant Orthopedic Designs North America, Inc.

K-Number K210146

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FAJ 2022-04-13

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System

Applicant OTU Medical, Inc.

K-Number K212202

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MHX 2022-04-13

CARESCAPE B650, E-musb

Applicant GE Healthcare Finland Oy

K-Number K213181

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GEX 2022-04-13

MCL 31 Dermablate System

Applicant Asclepion Laser Technologies GmbH

K-Number K210634

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LZA 2022-04-13

Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

Applicant Summit Glove, Inc.

K-Number K220373

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MUH 2022-04-13

OpenSensorX Series

Applicant Dentimax, Inc.

K-Number K220556

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FYC 2022-04-13

Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

Applicant Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.

K-Number K210148

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MHX 2022-04-13

CARESCAPE B450, E-musb

Applicant GE Healthcare Finland Oy

K-Number K213363

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LZA 2022-04-13

Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

Applicant Summit Glove, Inc.

K-Number K220375

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OLO 2022-04-13

Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning

Applicant Brainlab AG

K-Number K212245

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DZE 2022-04-13

ZENEX Implant System

Applicant Izenimplant Co., Ltd.

K-Number K211090

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KCT 2022-04-13

Neodent Implant System-Helix NGM Compact Surgical Kit Cases

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K214051

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