12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
FDA 510(k)
FDA Class 2
·Hematology
2.4MM LOCKING RECON SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036059330·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177591·12mm, 2-Hole Threaded Anterior Plate
Sklar®
FDA UDI
SKLAR CORPORATION·10649111204593·GUYON SOUNDS W/O THREAD 12FR
ZERO Profile Interlocking Cortex Screw, 3.5mm x 12mm, T15, Flex-Thread™
FDA UDI
FLOWER ORTHOPEDICS CORPORATION·00840118116817·Intramedullary fixation screw
Half Dome Posterior Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Armada 14 NC PTA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
2.4MM X 12MM HT X-DRIVE LOCKING RECON SCREW
FDA Adverse Event
Other
·BIOMET MICROFIXATION, INC.·Product code HWC·December 19, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
ENDOSTAT ELECTROSURGICAL UNIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·October 4, 2010
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD.·Product code GCX·November 15, 2012
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