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

FEG 2017-08-01

14Fr Colon Decompression Set, Macon Colon Decompression Set

Applicant Cook Ireland, Ltd.

K-Number K171619

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EIH 2017-08-01

Zirconia Dental Ceramics

Applicant Chengdu Besmile Biotechnology Co., Ltd.

K-Number K170894

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HQD 2017-08-01

HEXA100 (hexafocon A) Daily Wear Contact Lenses

Applicant Contamac, Ltd.

K-Number K171077

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NKG 2017-08-01

M.U.S.T. MINI Posterior Cervical Screws System

Applicant Medacta International S.A.

K-Number K171369

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JWY 2017-08-01

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 8 ug/mL

Applicant Thermo Fisher Scientific

K-Number K171870

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QYX 2017-08-01

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L

Applicant Lifewatch Services, Inc.

K-Number K170565

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EOB 2017-08-01

AED Sinuscope

Applicant National Advanced Endoscopy Devices, Inc.

K-Number K170285

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DXN 2017-08-01

BP5S Wireless Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K171062

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JTN 2017-08-01

HardyDisk AST Delafloxacin 5 µg (DLX5)

Applicant Hardy Diagnostics

K-Number K171975

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MOL 2017-08-01

Trojan Supra Lubricated Polyurethane Male Condom

Applicant Church & Dwight Co., Inc.

K-Number K171639

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JOY 2017-08-01

Advanced RBC Application

Applicant CellaVision AB

K-Number K171315

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GEX 2017-08-01

Q-Switched Nd:YAG Laser System

Applicant Ids, Ltd.

K-Number K171079

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