13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
COCAINE METABOLITE EIA ASSAY MODIFICATION
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690101192·Congruent Tibial Insert, Size 1 x 16mm
ZAVATION
FDA UDI
Zavation LLC·00842166191280·Polyaxial Reduction Screw 5.0x16
NA
FDA UDI
Zimmer, Inc.·00889024103801·
NA
FDA UDI
Zimmer, Inc.·00889024077850·
PEDIATRIC AND INFANT CATH KITS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PREP SHAVE KIT (NON-STERILE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Zimmer, Inc.·00889024077843·
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 14, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·December 21, 2010
PRISMAFLEX M100 SET
FDA Adverse Event
Malfunction
·GAMBRO INDUSTRIES·Product code KDI·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