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

KNW 2022-06-03

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle

Applicant Guangzhou Shengwei Medical Devices Co., Ltd.

K-Number K214063

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LON 2022-06-03

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

Applicant bioMerieux, Inc.

K-Number K213931

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ONG 2022-06-03

Multifrax Laser System

Applicant Paradigm Medical Corporation

K-Number K213332

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OLO 2022-06-03

Knee 3

Applicant Brainlab AG

K-Number K220652

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LZU 2022-06-03

SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

Applicant Oasis Medical, Inc.

K-Number K213988

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LZA 2022-06-03

Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim

Applicant Riverstone Resources Sdn Bhd

K-Number K220672

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QRL 2022-06-03

MICROLET NEXT lancing device, MICROLET Lancet

Applicant Ascensia Diabetes Care U.S., Inc.

K-Number K220633

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PGY 2022-06-03

21HQ613D

Applicant Lg Electronics.Inc

K-Number K221061

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ODG 2022-06-03

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

Applicant Fujifilm Corporation

K-Number K214089

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MYE 2022-06-03

Gastric Alimetry System

Applicant Alimetry , Ltd.

K-Number K213924

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GEI 2022-06-03

SILKRO

Applicant Hironic Co., Ltd.

K-Number K210084

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QDB 2022-06-03

Atrial Fibrillation History Feature

Applicant Apple, Inc.

K-Number K213971

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