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

GZT 2022-05-13

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)

Applicant Thompson Surgical Instruments, Inc.

K-Number K210615

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LNH 2022-05-13

MAGNETOM Skyra Fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K220589

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FMI 2022-05-13

Sterile Safety Hypodermic Needles for Single Use

Applicant Zhejiang Kangkang Medical-Devices Co., Ltd.

K-Number K213535

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FXX 2022-05-13

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP

Applicant Unimax Medical Products Co., Ltd.

K-Number K220749

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MIB 2022-05-13

Pre-Formed Penile Silicone Block

Applicant International Medical Devices, Inc.

K-Number K220760

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PND 2022-05-13

Provena(TM) Midline Catheter

Applicant C.R. Bard, Inc.

K-Number K213203

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JAK 2022-05-13

XACT ACE Robotic System

Applicant Xact Robotics, Ltd.

K-Number K221116

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EJK 2022-05-13

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

Applicant Prevest Denpro Limited

K-Number K212475

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HSB 2022-05-13

Flow-Nail

Applicant Flow-Fx, LLC

K-Number K221115

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MAI 2022-05-13

Arthrex Self-Punching PushLock Suture Anchor

Applicant Arthrex, Inc.

K-Number K221099

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OVD 2022-05-13

ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System

Applicant MiRus, LLC

K-Number K220115

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LLZ 2022-05-13

Quantib Prostate

Applicant Quantib B.V.

K-Number K221106

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