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

PZI 2017-01-06

StatStrip Xpress 2 Glucose Hospital Meter System

Applicant Nova Biomedical Corporation

K-Number K163490

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DZE 2017-01-05

Chaorum Implant System

Applicant Medimecca Co., Ltd.

K-Number K160536

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GGN 2017-01-05

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

Applicant Maine Standards Company, LLC

K-Number K162705

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LSE 2017-01-05

LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

Applicant DiaSorin, Inc.

K-Number K162961

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MCW 2017-01-05

Turbo-Power (2.0mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K-Number K162561

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LLZ 2017-01-05

Arterys Cardio DL

Applicant Arterys, Inc.

K-Number K163253

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GEH 2017-01-05

C2 Cryoballoon Ablation System

Applicant C2 Therapeutics, Inc.

K-Number K161202

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NKG 2017-01-05

Poseidon OCT Spinal Fixation System

Applicant Medyssey USA, Inc.

K-Number K161637

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LZA 2017-01-05

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)

Applicant Brightway Holdings Sdn. Bhd.

K-Number K162146

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MQF 2017-01-05

CrossBay IVF Embryo Transfer Catheter Set

Applicant Crossbay Medical, Inc.

K-Number K162064

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DQY 2017-01-05

YOGA Microcatheter

Applicant Codman & Shurtleff, Inc.

K-Number K162563

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GDW 2017-01-05

ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm

Applicant Ethicon Endo-Surgery, LLC

K-Number K163454

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