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

LNH 2022-06-10

Swoop Portable MR Imaging System

Applicant Hyperfine, Inc.

K-Number K221393

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GZB 2022-06-10

Nalu Neurostimulation System

Applicant Boston Scientific Neuromodulation

K-Number K221376

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HRS 2022-06-10

Omni Foot and Ankle Plating System

Applicant Exremity Medical, LLC

K-Number K221362

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QPB 2022-06-10

PAL System

Applicant Microaire Surgical Instruments, LLC

K-Number K212024

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DQA 2022-06-10

WesperO2

Applicant Wesper, Inc.

K-Number K213515

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PBK 2022-06-10

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Applicant Centers for Disease Control and Prevention

K-Number K221658

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OUR 2022-06-10

iFuse-TORQ® Implant System

Applicant SI-BONE, Inc.

K-Number K213667

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HWC 2022-06-10

Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System

Applicant Stryker GmbH

K-Number K220319

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FYC 2022-06-10

Surgical Isolation Cover Gown

Applicant Wuhan Dymex Healthcare Co., Ltd.

K-Number K220528

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MCW 2022-06-09

Auryon Atherectomy System

Applicant Eximo Medical, Ltd.

K-Number K221077

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GEI 2022-06-09

ACUTRON

Applicant Ilooda Co,., Ltd.

K-Number K211000

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PIF 2022-06-09

Nasogastric Feeding Tubes - ENFit Port - PVC

Applicant Cair Lgl

K-Number K213258

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