17 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DEVON DISPOSABLE HEAD POSITIONER COVER
FDA 510(k)
FDA Class 1
·General Hospital
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OP-CON SURG. INSTRUMENT #10
FDA 510(k)
FDA Class 1
·Neurology
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 3, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 13, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 9, 2010
COMP RVS CNTRL SCR 6.5X35MM ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 7, 2018
COMP LOCKING SCREW 4.75X15MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 7, 2018
COMP PRIMARY STEM 10MM MINI
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·February 7, 2018
COMP LOCKING SCREW 4.75X25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 7, 2018
ARCOM XL 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 7, 2018
COMP NON-LCKNG SCREW 4.75X25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 7, 2018
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 7, 2018
UNKNOWN SHOULDER PROSTHESIS SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·February 7, 2018
COMP RVS HMRL TI TRAY 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 7, 2018
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 7, 2018
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020