8 results
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35ms
·
Sources: EU EUDAMED, US FDA
RINGCAPS
FDA 510(k)
FDA Class 1
·Hematology
SmoothSkin Pure Switch (SSC1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABX MINOTROL 16
FDA Adverse Event
Other
·HORIBA MEDICAL·Product code GKZ·June 6, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 23, 2012
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·September 22, 2010
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