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

MSB 2021-07-29

OCS Lung Solution

Applicant TransMedics, Inc.

K-Number K211314

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DYH 2021-07-29

FiteBac CC OrthoSeal

Applicant Largent Health, LLC

K-Number K210115

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DZE 2021-07-29

BTI Extra-Short Dental Implant System UnicCa

Applicant B.T.I. Biotechnology Institute, Sl.

K-Number K202825

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JWH 2021-07-29

GMK Sphere Revision

Applicant Medacta International S.A.

K-Number K211664

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KCT 2021-07-29

Straumann Surgical Cassettes

Applicant Straumann USA, LLC

K-Number K203753

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LZA 2021-07-29

Disposable Nitrile Medical Examination Glove

Applicant Siyang Threeguard Medical Supplies Co., Ltd.

K-Number K211131

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HRS 2021-07-28

FINE Osteotomy

Applicant Bodycad Laboratories, Inc.

K-Number K211646

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FXX 2021-07-28

Purism Disposable Surgical Mask

Applicant Chuzhou Daddy'S Choice Science and Technology Co., Ltd.

K-Number K210856

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NHA 2021-07-28

MIS Ti-base abutment

Applicant Dentsply Sirona

K-Number K211225

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FXX 2021-07-28

TAIJI Professional Series Level 3 Surgical Face Mask

Applicant Taiji Medical Supplies, Inc.

K-Number K211861

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KRO 2021-07-28

ELEOS Limb Salvage System

Applicant Onkos Surgical

K-Number K211677

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FXX 2021-07-28

Surgical Mask

Applicant Honeywell Safety Products

K-Number K211497

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