22 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
FDA 510(k)
FDA Class 2
·Radiology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151019·Endo Carry-on Procedure Kit contains Basin, VIA...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776401306·Spatula Osteotome, 3.7mm, 14cm
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036008338·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173497·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173473·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173459·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173480·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173510·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173503·
ULTRAPAK NEHA
FDA 510(k)
FDA Unclassified
·Unknown
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
FDA 510(k)
FDA Class 2
·Cardiovascular
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193022691·B-P HIP ACETABULAR FIXATION CUP W/BIOCOAT & W/U...
SYNOVO HIP COMPONENTS
FDA UDI
Synovo Production·00814193025883·HIP ACETABULAR FIXATION CUP - 70 MM 5 HOLE
TPS
FDA UDI
STRYKER CORPORATION·04546540074768·Straight Long "AM" Irrigation Clip
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·March 19, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·March 1, 2011
ATLAS + VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2008
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·October 1, 2003