8 results
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17ms
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Sources: EU EUDAMED, US FDA
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
FDA 510(k)
FDA Class 1
·Hematology
HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
FDA 510(k)
FDA Class 1
·Dental
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 11, 2013
CURRENT PLUS VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011
ZIMMER STRAIGHT SCREWDRIVER SHANK
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HXX·July 18, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024