1,282 results
·
56ms
·
Sources: EU EUDAMED, US FDA
EUROPEAN HEALTH CONCEPTS INC
FDA Adverse Event
EUROPEAN HEALTH CONCEPTS·Product code MWT·September 5, 2002
A&H SPINBRUSH UNSPECIFIED
FDA Adverse Event
Malfunction
·CHURCH & DWIGHT CO., INC.·Product code JEQ·August 19, 2019
ETHICON INC
FDA Adverse Event
Injury
·JOHNSON & JOHNSON·Product code FTL·January 11, 2009
DURA SUBSTITUTE
FDA Adverse Event
Malfunction
·COLLAGEN MATRIX, INC.·Product code GXQ·November 15, 2017
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 11, 2026
Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
FDA Enforcement
Class II
·Terminated·Custom Spine, Inc.·August 7, 2013
ARTEFILL
FDA Adverse Event
Injury
·SUNEVA·Product code LMH·November 13, 2011
ADVANCED BIONICS U.S. PAT. 366 HIRES 9011
FDA Adverse Event
Injury
·CANNON TECHNOLOGIES INC·Product code MCM·April 23, 2010
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·March 14, 2018
Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·November 28, 2012
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·March 14, 2018
SUREFORM
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code GDW·July 3, 2025
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·August 6, 2024
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·January 27, 2026
BARD COMPOSIX KUGEL EXTRA LARGE OVAL 8.7X10.7
FDA Adverse Event
C.R. BARD INC·Product code FTL·April 22, 2013
MIC-KEY GASTROSTOMY FEEDING TUBE KIT (NON-ENFIT)
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·December 5, 2023
DA VINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·December 2, 2025
TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·May 12, 2025
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·May 12, 2025
PULSE GEN MODEL 104
FDA Adverse Event
Injury
·CYBERONICS - HOUSTON·Product code LYJ·September 19, 2022