17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Humeral Cup Standard
FDA UDI
FX SOLUTIONS·03701037310588·HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037308547·TRIAL HUMERAL CUP 135/145° STANDARD Ø32 +3
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819902·Deep Deaver Retractor 4in wide 7in w/Doyen Handle
32mm Glenosphere and Humeral Cup
FDA UDI
FX SOLUTIONS·03701037313879·STANDARD TRIAL HUMERAL CUP CUSTOM MADE 135/145°...
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018388·Scissors Punch 3.5mm 30 degree left
ORTHO ELISA BAR CODE READER II
FDA Adverse Event
Malfunction
·INTERMEC CORP·Product code JTC·March 31, 2000
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
FDA 510(k)
FDA Class 2
·Radiology
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
FDA 510(k)
FDA Class 2
·Orthopedic
VERCISE? CARTESIA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·August 1, 2025
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
CLOSURE TAPE USED TO SECURE VAG DELIVERY PACK
FDA Adverse Event
Other
·SRI SURGICAL·Product code FRG·August 14, 2008
Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube Catalog Number: NEA105 For in-vitro diagnostic use
FDA Recall
Terminated
·Perkinelmer Life Sciences, Inc.·Product code CIB·July 28, 2003
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 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