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

KTT 2020-09-14

FusionFrame Ring Lock System

Applicant Glw Medical Innovation

K-Number K200343

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JXI 2020-09-14

VersaWrap Nerve Protector

Applicant Alafair Biosciences, Inc.

K-Number K201631

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KRA 2020-09-14

Marathon Flow Directed Micro Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K202318

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OVE 2020-09-14

Shoreline ACS (Anterior Cervical System)

Applicant SeaSpine Orthopedics Corporation

K-Number K201646

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PNR 2020-09-12

Disposable Enteral Feeding Syringe with Enfit Connector

Applicant Shinva Ande Healthcare Apparatus Co., Ltd.

K-Number K193657

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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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