12 results
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18ms
·
Sources: EU EUDAMED, US FDA
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
FDA 510(k)
FDA Class 2
·Hematology
Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1)
FDA UDI
AALTO SCIENTIFIC·B085K852M200·
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106310·CASTROVIEJO FORCEPS 0.5MM
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209109395·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111206108·GUYON SOUND W/O THREAD 20FR
ZERO Profile Interlocking Cortex Screw, 3.5mm x 20mm, T15, Flex-Thread™
FDA UDI
FLOWER ORTHOPEDICS CORPORATION·00840118116855·Intramedullary fixation screw
RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Magicore System
FDA 510(k)
FDA Class 2
·Dental
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD.·Product code GCX·November 15, 2012
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 18, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022