10 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALIBRATION VERIFICATION ASSESSMENT (CVA)
FDA 510(k)
FDA Class 2
·Hematology
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295233350·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING TC3 5 ...
Full Automatic (NIBP) Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·February 14, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·January 13, 2011
ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·June 24, 2014
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 5, 30.0 mm; Ref 96-0557.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005