Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MQB 2022-04-14

Yushan X-Ray Flat Panel Detector with DROC

Applicant Innocare Optoelectronics Corp.

K-Number K220510

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JOW 2022-04-14

Amputee Garment for use with Lympha Press Optimal Plus

Applicant Mego Afek AC , Ltd.

K-Number K214053

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FGE 2022-04-13

BIOTEQ Drainage Catheter BT-PDS-series

Applicant Bioteque Corporation

K-Number K210419

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QJP 2022-04-13

Bendit21 Microcatheter

Applicant Bend IT Technologies, Ltd.

K-Number K203842

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MHX 2022-04-13

Carescape B850, E-musb

Applicant GE Healthcare Finland Oy

K-Number K213336

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NUC 2022-04-13

Sensuva Premium Silicone Personal Lubricant

Applicant Valencia Naturals, Inc.

K-Number K212260

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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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