Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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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ELW 2021-07-28

Dental Impression Material

Applicant Nanchang Dental Bright Technology Co., Ltd.

K-Number K211489

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EHD 2021-07-28

Portray

Applicant Surround Medical Systems

K-Number K211014

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DTK 2021-07-28

Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach

Applicant William Cook Europe Aps

K-Number K211875

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LZO 2021-07-28

Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads

Applicant Corin, Ltd.

K-Number K201657

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