12 results
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26ms
·
Sources: EU EUDAMED, US FDA
PRESSURE GAUGE
FDA 510(k)
FDA Class 2
·Anesthesiology
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111031·INSTRUMENT CADDY LARGE
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
FDA 510(k)
FDA Class 2
·Cardiovascular
LATERAL STRAIGHT STEM 15.0 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·March 28, 2012
SMARTSET GMV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·December 8, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 22, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 9, 2014
SULOX-HD 32 M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·April 23, 2019
SULOX, HEAD, M¸ 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·August 3, 2018
SULOX-HEAD 28 M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·April 4, 2019
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
FDA Enforcement
Class I
·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021