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

GEX 2017-05-19

MICRORUPTOR 6

Applicant Meridian AG

K-Number K160677

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HJO 2017-05-19

SLIT LAMP SL-2000

Applicant Nidek Co., Ltd.

K-Number K163564

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NVP 2017-05-19

Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber

Applicant Thayer Medical Corporation

K-Number K160109

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FZP 2017-05-19

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip

Applicant AtriCure, Inc.

K-Number K163261

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JDX 2017-05-19

PIEZOTOME M+, PIEZOTOME M+ Handpiece

Applicant Satalec-Acteon Group

K-Number K163610

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IYE 2017-05-19

BEAMSCAN

Applicant Ptw-Freiburg Physikalisch Technische-Werksraetten

K-Number K161807

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DQD 2017-05-19

Eko Model E5 System (EME5), Eko DUO

Applicant Eko Devices, Inc.

K-Number K170874

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PUQ 2017-05-19

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

Applicant Bio-Rad Laboratories

K-Number K170509

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OOE 2017-05-19

Catalys Precision Laser System

Applicant Abbott Medical Optics, Inc.

K-Number K170322

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HBW 2017-05-19

Stryker Universal Neuro III System AXS Screw

Applicant Stryker

K-Number K171152

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GEI 2017-05-19

PK AIM

Applicant Gyrus Acmi, Inc.

K-Number K170908

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OMA 2017-05-19

Nihon Kohden QP-160AK EEG Trend Program

Applicant Nihon Kohden Corporation

K-Number K163644

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