12 results
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18ms
·
Sources: EU EUDAMED, US FDA
SPINALPLANE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704262193·
NEW COBE SATURATION/HEMATOCRIT MONITOR
FDA 510(k)
FDA Class 2
·Hematology
FLOW-PAC CALCIUM REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·July 16, 2014
SYSTEM 7 SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·January 30, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 4, 2014
ADVANCE(R) II COCR TIBIAL BASE
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRY·December 21, 2010
ECHOTIP ULTRA ULTRASOUND ASPIRATION NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·November 19, 2010
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 29, 2014
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·September 17, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024