18 results
·
31ms
·
Sources: EU EUDAMED, US FDA
ELASTOPLAST HEAT PLASTER
FDA 510(k)
FDA Class 2
·Physical Medicine
OPHTIMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
INFANT REFLUX SLING
FDA 510(k)
FDA Class 1
·General Hospital
DRILL, AO, STERILE T2 FEMUR 4,2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HTW·December 18, 2012
ENDOTRACHEAL TUBE 7.5 MM EMG FLEX
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code BTR·July 28, 2010
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·December 16, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·June 1, 2020
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
NC QUANTUM APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·January 22, 2013
MITEK EXPRESSEW III NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code LXH·July 10, 2014
ENDOTRACH TUBE 8229306J NIM EMG 6MM
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC·Product code ETN·March 6, 2013
ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·May 10, 2013
ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·March 11, 2013
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·August 26, 2013
ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·February 11, 2013
NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·October 18, 2021
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·August 28, 2013
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·January 30, 2019