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

DQX 2022-12-19

Mechanical Guidewire

Applicant Baylis Medical Company, Inc.

K-Number K221351

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PGM 2022-12-19

MARVEL Growing Rods

Applicant Globus Medical, Inc.

K-Number K213196

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OWQ 2022-12-19

ViewFlex Xtra Reprocessed ICE Catheter

Applicant ABBOTT MEDICAL

K-Number K222217

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OZT 2022-12-18

INOUE BALLOON A

Applicant Toray Industries, Inc.

K-Number K220881

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KOD 2022-12-16

Wellead Ureteral Catheter

Applicant Well Lead Medical Co., Ltd.

K-Number K220036

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DQA 2022-12-16

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)

Applicant Shenzhen Zhengkang Technology Co., Ltd.

K-Number K213984

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MBI 2022-12-16

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

Applicant Auxein Medical Private Limited

K-Number K213110

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FMK 2022-12-16

BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets

Applicant Becton, Dickinson and Company

K-Number K223243

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QIH 2022-12-16

BrainInsight

Applicant Hyperfine, Inc.

K-Number K223268

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QIH 2022-12-16

Saige-Density

Applicant DeepHealth, Inc.

K-Number K222275

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ITI 2022-12-16

KLICK (VARIANTS: POWER, RACE, MONSTER)

Applicant Klaxon Mobility GmbH

K-Number K222502

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MYN 2022-12-16

Overjet Calculus Assist

Applicant Overjet, Inc.

K-Number K220928

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