14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Atlas Gold PTA Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023
Lateral Patient Positioning System
FDA UDI
ALPHATEC SPINE, INC.·00190376484181·Pelvic Anterior Pad
Lateral Patient Positioning System
FDA UDI
ALPHATEC SPINE, INC.·00190376513195·Pelvic Anterior Pad, Thin
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE 16 X 100 MM X 8.5 ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 29, 2017
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS, LLC.·Product code HQL·July 8, 2011
LOFRIC PRIMO
FDA Adverse Event
Injury
·WELLSPECT HEALTHCARE·Product code GBM·June 14, 2013
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 23, 2008
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 29, 2023
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021