11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIMESH SELF DRILLING SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
FDA 510(k)
FDA Class 2
·Anesthesiology
MAXIM RPG PS FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·May 25, 2012
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 8, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 12, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·June 18, 2008
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
TAMPONADE URETERINE BALLOON CATHETER SET
FDA Adverse Event
Injury
·COOK UROLOGICAL·Product code KNA·October 16, 2007
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015