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

MQV 2017-01-18

NovaBone IRM

Applicant Novabone Products, LLC

K-Number K163310

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EQJ 2017-01-17

Precision Thin Reciprocating Blade, 0.010in.

Applicant Stryker Corporation

K-Number K161514

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KHE 2017-01-17

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

Applicant Immunostics Inc.,

K-Number K163554

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GZJ 2017-01-17

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A

Applicant Well-Life Healthcare Limited

K-Number K162663

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PHX 2017-01-17

Humelock Reversed Shoulder

Applicant Fx Solutions

K-Number K162455

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LIT 2017-01-17

Chameleon PTA Balloon Catheter

Applicant Av Medical Technologies, Ltd.

K-Number K163231

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HGH 2017-01-13

PANPAC DISPOSABLE VACUUM CURETTES

Applicant Panpac Medical Corporation

K-Number K161106

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PKQ 2017-01-13

Cantab Mobile

Applicant Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.

K-Number K161328

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OHS 2017-01-13

RED Light Device

Applicant Zhongshan Bisen Plastic Electronic Products Co., Ltd.

K-Number K162489

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JIT 2017-01-13

Lumipulse G FSH-N Calibrators

Applicant Fujirebio Diagnostics,Inc.

K-Number K163534

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MVL 2017-01-13

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord

Applicant Kerr Corporation

K-Number K162164

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GXP 2017-01-13

OsteoVation Impact

Applicant Skeletal Kinetics, LLC

K-Number K162864

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