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

BSO 2016-08-12

Perifix and Contiplex Catheter

Applicant B.Braun Medical, Inc.

K-Number K153297

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MOT 2016-08-12

Raycell Mk2

Applicant Best Theratronics Limited

K-Number K161324

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GEI 2016-08-12

Thermi RF Accessories

Applicant Thermi

K-Number K161661

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FOZ 2016-08-12

SUPERCATH 6

Applicant Togo Medikit Co., Ltd.

K-Number K160592

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EIH 2016-08-12

CELTRA Press

Applicant Dentsply Sirona

K-Number K161269

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OUR 2016-08-12

RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems

Applicant Medtronic Sofamor Danek

K-Number K161210

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MRG 2016-08-12

ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls

Applicant Abbott Laboratories

K-Number K153375

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EKX 2016-08-12

EMS-200

Applicant Meta Systems Co., Ltd.

K-Number K153285

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GAT 2016-08-12

'cottony' II TAPE, PLEDGETS

Applicant Teleflexmedical, Inc.

K-Number K153089

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NOP 2016-08-12

EUROIMMUN Anti-West Nile Virus ELISA (IgM)

Applicant Euroimmun Us, Inc.

K-Number K153308

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FDF 2016-08-11

Aer-O-Scope Colonoscope System

Applicant Gi View , Ltd.

K-Number K161791

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HSN 2016-08-11

Salto XT, Salto Talaris

Applicant Tornier S.A.S.

K-Number K153452

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