22 results · 21ms · Sources: EU EUDAMED, US FDA

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PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

SCANLAN® Legacy Micro Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159033571·Legacy FRCP FH 1X2MT 0.5MM DD 10"

ILT 0.014 CATHETER, MODEL C114NL2

FDA 510(k)
FDA Class 2 ·Cardiovascular

MACROPOREDX DISTRACTOR SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

AUTOSOFTÂ XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·August 2, 2024

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·July 24, 2024

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·July 14, 2024

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·July 14, 2024

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

GEL-FILL MAMMARY IMPLANT, 500 CC

FDA Adverse Event
Injury ·MCGHAN MEDICAL, INC.·Product code FTR·November 11, 1994

LYNX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 14, 2013

DILATATION CATHETER, BALLOON

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LJE·March 1, 2011

IAB: 8 FR- 40 CC

FDA Adverse Event
Injury ·ARROW INTL., INC.·Product code DSP·February 25, 2008

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013