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

FED 2016-10-12

ClearPetra Suction-Evacuation Sheath

Applicant Well Lead Medical Co., Ltd.

K-Number K161110

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GEH 2016-10-11

IcePearl 2.1 CX L, IceForce 2.1 CX L

Applicant Galil Medical , Ltd.

K-Number K162599

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HWC 2016-10-11

HammerTech Fixation System

Applicant Fusion Orthopedics, LLC

K-Number K161449

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KCT 2016-10-07

Sterilization Tray

Applicant STERIS Corporation

K-Number K160912

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LJS 2016-10-07

Turbo-Flo PICC Sets

Applicant Cook Incorporated

K-Number K161496

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MQL 2016-10-07

Cryotop Vitrification Kit and Cryotop Thawing Kit

Applicant Kitazato Biopharma Co., Ltd.

K-Number K160864

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DQK 2016-10-07

EnSite Velocity Surface Electrode Kit

Applicant St Jude Medical

K-Number K160186

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LOX 2016-10-07

Pantera Pro

Applicant Biotronik, Inc.

K-Number K160985

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GEI 2016-10-07

PK Morcellator

Applicant Gyrus Acmi, Inc.

K-Number K161038

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OXZ 2016-10-07

Prestige Ameritech Pediatric/Child’s Face mask

Applicant Prestige Ameritech

K-Number K160100

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BZG 2016-10-07

SpiroScout

Applicant Ganshorn Medizin Electronic GmbH

K-Number K160116

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KWQ 2016-10-07

Pyrenees Cervical Plate System

Applicant K2m, Inc.

K-Number K162664

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