22 results · 24ms · Sources: EU EUDAMED, US FDA

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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