16 results
·
62ms
·
Sources: EU EUDAMED, US FDA
MICRUSFRAME10 3MM X 5.4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 5, 2019
SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code OBJ·October 14, 2021
POWERWIRE RADIOFREQUENCY GUIDEWIRE
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code PDU·January 7, 2021
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·REFER TO SECTION H10·Product code KRD·November 14, 2018
DELTAFILL18 12MM X 42CM
FDA Adverse Event
Malfunction
·SEE H.10·Product code KRD·July 23, 2018
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code MIH·July 16, 2018
ATLAS WIRE FLAT WIRE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·September 11, 2023
TUTOPATCH
FDA Adverse Event
Injury
·TUTOGEN MEDICAL GMBH·Product code GXQ·July 5, 2019
Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104
FDA Recall
Terminated
·Lumenis Inc.·Product code GEX·February 1, 2006
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Death
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·September 3, 2024
OPTIMA COIL SYSTEM
FDA Adverse Event
Malfunction
·BALT USA·Product code HCG·November 7, 2024
European Healthcare & Device Solutions Ltd.
Authorized representative
🇮🇪 Ireland·66 Manufacturers·867 Devices
OPEN MIND LABORATORY LTD
Importer
🇷🇴 Romania·11 Manufacturers
Medical Technology Promedt Consulting GmbH
Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·July 1, 2014
Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
FDA Recall
Terminated
·Solta Medical, Inc.·Product code ONG·December 15, 2010