8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TCBS
FDA 510(k)
FDA Class 1
·Microbiology
DRIONIC
FDA 510(k)
FDA Class 2
·Physical Medicine
ACTIVAT-PARTIAL THROMBO-PLASTIN
FDA 510(k)
FDA Class 2
·Hematology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 15, 2012
CONSERVE(R) PLUS FEMORAL
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code NXT·September 14, 2010
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020