22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP
FDA 510(k)
FDA Class 2
·Orthopedic
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
gammaCore-2
FDA 510(k)
FDA Class 2
·Neurology
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·June 13, 2014
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 13, 2012
ON-Q PAIN PUMP
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·September 8, 2010
S-ROM M HEAD 36MM -3
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code LPH·October 18, 2012
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 18, 2012
S-ROM*SLEEVE PRX ZTT, 20B-LRG
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·October 18, 2012
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·October 18, 2012
APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·October 18, 2012
PINN CAN BONE SCREW 6.5MMX40MM
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code NDJ·October 18, 2012
PINN CAN BONE SCREW 6.5MMX40MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code NDJ·October 18, 2012
ASPHERE M SPEC 11/13 36 -3
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code LPH·October 18, 2012
PINNACLE SECTOR II CUP 50MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·October 18, 2012
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 18, 2012
S-ROM*SLEEVE PRX ZTT, 18D-LRG
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·October 18, 2012
SROM*STM ST,36+8L NK,18X13X160
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code JDI·October 18, 2012
APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·October 18, 2012