16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAINLESS STEEL GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
DC 7
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD.·Product code GCX·May 25, 2012
RECEPTAL 1.5LITER PE/CE WITH (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·August 1, 2011
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
NON-PVC RECEPT. LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
RECEPTAL 1.5 LITER PE/CE WITH (50/CASE)
FDA Adverse Event
Injury
·HOSPIRA LTD.·Product code GCX·November 18, 2010
RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·June 24, 2011
RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·June 24, 2011
UNIVERSAL OCILLATING SAW ATTACHMENT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A·Product code GEY·March 6, 2014
X-STOP® INTERSPINOUS SPACER
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NQO·November 14, 2012
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·June 10, 2015
UNK BACTISEAL EVD CATHETER
FDA Adverse Event
Injury
·Product code JXG·November 21, 2017
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024