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

OCC 2017-09-29

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

Applicant Alere Scarborough, Inc.

K-Number K171792

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GAM 2017-09-29

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture

Applicant Cpt Sutures Co., Ltd.

K-Number K170166

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IRP 2017-09-29

Med4 Elite

Applicant Cool Systems, Inc. (Dba Game Ready)

K-Number K171685

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DZE 2017-09-29

Thommen Implant System

Applicant Thommen Medical AG

K-Number K171795

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HHI 2017-09-29

Berkeley VC-10 Vacuum Curettage System

Applicant Gyrus Acmi

K-Number K171440

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JAD 2017-09-29

Photoelectric Therapy System

Applicant Xstrahl, Ltd.

K-Number K172080

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LJS 2017-09-29

Sherlock 3CG Tip Positioning System Stylet

Applicant C.R. Bard, Inc.

K-Number K172397

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IYN 2017-09-29

Voluson E6, Voluson E8, Voluson E10

Applicant GE Healthcare

K-Number K172342

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MXC 2017-09-29

Confirm Rx Insertable Cardiac Monitor (ICM) System

Applicant St. Jude Medical, Inc.

K-Number K163407

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NZP 2017-09-29

SecurePortIV Catheter Securement Adhesive

Applicant Adhezion Biomedical, LLC

K-Number K170505

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IYO 2017-09-29

BR-FHUS Navigation 1.0

Applicant Taihao Medical, Inc.

K-Number K171309

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MAX 2017-09-29

Calix Lumbar Spinal Implant System

Applicant X-Spine Systems, Inc.

K-Number K170119

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