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

MQL 2016-08-15

Sydney IVF Gamete Buffer

Applicant William A. Cook Australia Pty. , Ltd.

K-Number K153478

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PGY 2016-08-15

Dell UP3216Q with QUBYX PerfectLum bundle

Applicant Qubyx Software Technologies, Inc.

K-Number K162196

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OUY 2016-08-15

Solana Trichomonas Assay

Applicant Quidel Corporation

K-Number K161182

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DPS 2016-08-12

ECG100+, ECG200+

Applicant Cardioline S.P.A

K-Number K160840

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GEI 2016-08-12

LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp

Applicant Covidien

K-Number K160331

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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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