15 results · 51ms · Sources: EU EUDAMED, US FDA

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Sovereign-Gear

FDA UDI
COOL APPROACH LIMITED·05060505400014·A home-use infrared forehead thermometer.

Sovereign-Gear

FDA UDI
COOL APPROACH LIMITED·05060505400007·A flexible tipped home-use waterproof digital t...

THERAPY? COOL PATH ? DUO ABLATION CATHETER

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.·Product code OAD·December 9, 2014

THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L1-TE4BE1EB

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code OAD·December 20, 2013

COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·March 21, 2012

ARCTIC SUN STAT

FDA Adverse Event
Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·September 26, 2024

SHTHERAPY COOL PATH, 1304-CP-7-25-LC-BD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code LPB·May 14, 2012

THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code OAD·October 24, 2013

UNK - IMPLANT

FDA Adverse Event
Injury ·DEPUY MITEK LLC US·Product code MBI·October 23, 2024

THERAPY? COOL FLEX? ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.·Product code OAD·June 5, 2015

ARCTIC SUN STAT

FDA Adverse Event
Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·September 26, 2024

ZOLL IVTM THERMOGARD XP

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION·Product code NCX·May 15, 2020

ABRADER 5.5 EP-1 DSPL BLADE

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code HAB·August 18, 2020

ABRADER,4.0,EP-1,DSPL BLADE

FDA Adverse Event
Malfunction ·SMITH & NEPHEW, INC.·Product code HAB·March 20, 2020

IMPELLA

FDA Adverse Event
Injury ·ABIOMED, INC. - 1220648·Product code OZD·January 30, 2026