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

NHA 2017-05-22

OSSTEM Implant System - Abutment

Applicant Osstem Implant Co., Ltd.

K-Number K161689

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HWC 2017-05-22

SMV Scientific Cannulated Screws

Applicant Smv Scientific

K-Number K170021

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JWH 2017-05-22

Smith & Nephew VISIONAIRE Adaptive Guides

Applicant Smith & Nephew, Inc.

K-Number K170282

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ITX 2017-05-22

Pinpoint GT Needle Guide Kits

Applicant C.R. Bard, Inc.

K-Number K171348

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GEX 2017-05-22

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

Applicant Lumenis, Ltd.

K-Number K170121

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HEX 2017-05-21

LT-300 SD Digital Video Colposcope

Applicant Lutech Industries, Inc.

K-Number K170446

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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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