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

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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LOX 2017-01-05

Sapphire II PRO

Applicant Orbusneich Medical, Inc.

K-Number K163114

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BZG 2017-01-05

EasyOne Air Spirometer

Applicant Ndd Medizintechnik AG

K-Number K161536

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KWQ 2017-01-05

LOSPA IS ACP System

Applicant Corentec Co., Ltd.

K-Number K161641

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GEI 2017-01-05

AGNES

Applicant Gowoonsesang Cosmetics Co., Ltd.

K-Number K160469

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ILY 2017-01-05

Vevazz LED Heat Lamp

Applicant Vevazz, LLC

K-Number K162763

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OXO 2017-01-04

B6

Applicant Beijing East Whale Imaging Technology Co., Ltd.

K-Number K163429

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DQA 2017-01-04

Caremed Reusable & Disposable SPO2 Sensors

Applicant Shenzhen Caremed Medical Technology Co., Ltd.

K-Number K153184

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