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

GKT 2020-09-11

AMICUS Separator System

Applicant Fresenius Kabi AG

K-Number K200530

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MEG 2020-09-11

TK Insulin Syringe with/without Saftey Retractable Device

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K191639

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NPM 2020-09-11

Porcine Mineral Collagen Composite Moldable

Applicant Collagen Matrix, Inc.

K-Number K201859

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PAO 2020-09-11

PERFORM Humeral System Stem

Applicant Tornier, Inc.

K-Number K201315

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HRS 2020-09-11

DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

Applicant DePuy Synthes

K-Number K201959

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LCO 2020-09-11

PF4 Enhanced assay

Applicant Immucor Gti Diagnostics, Inc.

K-Number K201570

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HGX 2020-09-11

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K-Number K193449

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KTT 2020-09-11

Dynex Micro

Applicant Vilex, LLC

K-Number K202143

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LPH 2020-09-11

DePuy PINNACLE Dual Mobility Liner

Applicant Depuy Ireland UC

K-Number K200854

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QDA 2020-09-11

Fitbit ECG App

Applicant Fitbit, Inc.

K-Number K200948

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DWJ 2020-09-11

HotDog Temperature Management Controller

Applicant Augustine Temperature Management

K-Number K201779

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ODP 2020-09-11

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

Applicant Meditech Spine, LLC

K-Number K201506

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