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