66 results
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52ms
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Sources: EU EUDAMED, US FDA
International Life Sciences
Manufacturer
🇺🇸 United States
INTERNATIONAL LIFE SCIENCES
FDA registration
INTERNATIONAL LIFE SCIENCES·5 products·🇺🇸 United States
BARRIGEL
FDA Adverse Event
Injury
·PALETTE LIFE SCIENCES·Product code OVB·April 14, 2026
Artelon FlexBand Plus Ref: 41054 & 41057
FDA Recall
Open, Classified
·International Life Sciences·Product code OWW·February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057
FDA Recall
Open, Classified
·International Life Sciences·Product code OWW·February 6, 2026
TRIFECTA STENTED TISSUE VALVE
FDA Adverse Event
Death
·ST. JUDE MEDICAL, COSTA RICA LTDA·Product code LWR·June 8, 2021
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
FDA Recall
Open, Classified
·International Life Sciences·Product code OWW·February 6, 2026
TRIFECTA STENTED TISSUE VALVE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, COSTA RICA LTDA·Product code LWR·June 8, 2021
MULTI-LUMEN/PSI SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DYB·April 20, 2010
PSI KIT: 8.5 FR X 4-1/8 (10 CM)
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code KGZ·August 27, 2010
Artelon FlexBand Dynamic Matrix Ref: 31057
FDA Enforcement
Class II
·Ongoing·International Life Sciences·March 18, 2026
Artelon FlexBand Plus Ref: 41054 & 41057
FDA Enforcement
Class II
·Ongoing·International Life Sciences·March 18, 2026
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
FDA Enforcement
Class II
·Ongoing·International Life Sciences·March 18, 2026
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·July 1, 2022
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·July 1, 2022
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·July 1, 2022
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB·Product code DRM·January 9, 2018
ARTELON TISSUE REINFORCEMENT
FDA Adverse Event
Injury
·INTERNATIONAL LIFE SCIENCES, D/B/A ARTELON·Product code FTL·July 16, 2015
ARTELON TISSUE REINFORCEMENT
FDA Adverse Event
Injury
·INTERNATIONAL LIFE SCIENCES, D/B/A ARTELON·Product code FTL·July 16, 2015
ARTELON TISSUE REINFORCEMENT
FDA Adverse Event
Injury
·INTERNATIONAL LIFE SCIENCES, D/B/A ARTELON·Product code FTL·July 16, 2015