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

KPR 2021-02-01

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems

Applicant Sedecal., Sa.

K-Number K203537

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GAT 2021-02-01

FAST-FIX FLEX

Applicant Smith & Nephew, Inc.

K-Number K203393

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MBI 2021-02-01

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture

Applicant Medos International SARL

K-Number K203794

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KGO 2021-02-01

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves

Applicant Guilin Hbm Health Protections, Inc.

K-Number K203483

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GCJ 2021-02-01

Monopolar Hook

Applicant Human Xtensions , Ltd.

K-Number K203603

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KTT 2021-02-01

Hoffmann LRF System

Applicant Stryker GmbH

K-Number K203568

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KWQ 2021-01-29

Prase-AP Anterior Cervical Plate System

Applicant Gbs Commonwealth Co., Ltd.

K-Number K202878

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BZD 2021-01-29

Luna® G3 BPAP 25A

Applicant 3B Medical, Inc.

K-Number K201620

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FYC 2021-01-29

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back

Applicant Wildcat Ppe, LLC

K-Number K202310

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LNH 2021-01-29

i_Space 1.5T Superconducting Magnetic Resonance Imaging System

Applicant Mri Division,Beijing Wandong Medical Technology Co., Ltd.

K-Number K192650

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HAW 2021-01-29

Disposable Pre-calibrated Suction

Applicant Brainlab AG

K-Number K201752

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FXX 2021-01-29

Protective Face Mask for Medical Use

Applicant Hunan Heng Chang Pharmaceutical Co., Ltd.

K-Number K202358

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