14 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690101185·Congruent Tibial Insert, Size 1 x 14mm
Cranial Fusion
FDA UDI
Life Spine, Inc.·00190837085322·
ZAVATION
FDA UDI
Zavation LLC·00842166191273·Polyaxial Reduction Screw 5.0x14
ELMED
FDA UDI
ELMED INCORPORATED·00842180159440·Brooks Style” non-sterile, reusable, medical-gr...
NA
FDA UDI
Zimmer, Inc.·00889024077836·
NA
FDA UDI
Zimmer, Inc.·00889024103795·
AMSET PLD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
E-SP COMBINED EPI SPINAL MINISET
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
Zimmer, Inc.·00889024077829·
TRIMA ACCEL
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code GKT·January 30, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·December 21, 2010
PFC*SIGMA/OV/DOME PAT 3PEG,38
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·July 15, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022