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

JDR 2017-02-01

Stealth Staple System

Applicant First Ray, LLC

K-Number K163440

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JWH 2017-02-01

U2 Total Knee System, PSA Tibial Insert

Applicant United Orthopedic Corporation

K-Number K161360

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LON 2017-02-01

VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)

Applicant bioMerieux, Inc.

K-Number K163083

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OAP 2017-01-31

Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352

Applicant Capillus, LLC

K-Number K163170

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FYC 2017-01-31

Medline Non-Surgical Isolation Gown-

Applicant Medline Industries, Inc.

K-Number K160471

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LLZ 2017-01-31

NobelClinician, DTX Studio implant

Applicant Nobel Biocare AB

K-Number K163122

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LZA 2017-01-31

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

Applicant Healthy Glove Co., Ltd.

K-Number K162381

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CEW 2017-01-31

IDS-iSYS Intact PTHN

Applicant Immunodiagnostic Systems , Ltd.

K-Number K161158

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IYN 2017-01-31

Acclarix LX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K162055

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GEI 2017-01-31

OsteoCool V-3 RF Ablation System

Applicant Baylis Medical Company, Inc.

K-Number K161949

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JAA 2017-01-31

Philips CombiDiagnost R90

Applicant Philips Medical Systems Dmc GmbH

K-Number K163210

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DSP 2017-01-31

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case

Applicant Datascope Corp.

K-Number K163542

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