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

CFR 2022-09-16

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

Applicant Roche Diagnostics

K-Number K220134

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GZL 2022-09-16

Neuro Omega System, NeuroSmart System

Applicant Alpha Omega Engineering , Ltd.

K-Number K220553

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ITI 2022-09-16

Electric Wheelchair, Model: 9000N

Applicant Silver Fox Corporation Limited

K-Number K221799

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HAW 2022-09-16

ClearPoint System

Applicant ClearPoint Neuro, Inc.

K-Number K222519

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QOG 2022-09-16

Tempo Smart Button

Applicant Eli Lilly and Company

K-Number K212217

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NKB 2022-09-16

True Tulip, True M.I.S.

Applicant Innovative Surgical Designs, Inc.

K-Number K220297

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OXC 2022-09-16

ECHELON ENDOPATH Staple Line Reinforcement

Applicant Ethicon Endo-Surgery, LLC

K-Number K221343

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NKB 2022-09-16

Altus Spine Pedicle Screw System

Applicant Altus Partners, LLC

K-Number K211027

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NBL 2022-09-16

L1P-1F (TRIOS 5)

Applicant 3Shape TRIOS A/S

K-Number K221249

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QQG 2022-09-16

Phagenyx System

Applicant Phagenesis Limited

K-Number DEN220025

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FXX 2022-09-16

Surgical Face Masks (Ear Loops And Tie-On)

Applicant San-M Package Co., Ltd.

K-Number K221534

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GEI 2022-09-16

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device

Applicant Stryker Corporation

K-Number K221074

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