8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RUBELISA TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
FDA 510(k)
FDA Class 2
·Microbiology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code PAH·February 27, 2013
ACCU-CHEK® ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 8, 2011
NEXGEN RHK ARTICULAR SURFACE W/HINGE POST
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KRO·July 24, 2014
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009