14 results · 21ms · Sources: EU EUDAMED, 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