101 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902097140·CYLN ENDO 18MM INNER TRAY
Disc Prep
FDA UDI
Life Spine, Inc.·00190837089917·
Wayne
FDA UDI
COOK INCORPORATED·00827002565364·Wayne Pneumothorax Set
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PASS LP SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WAYNE PNEUMOTHORAX SET
FDA Adverse Event
Injury
·COOK INC·Product code JOL·July 22, 2020
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 21, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·June 2, 2025
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·August 28, 2013
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 28, 2013
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 27, 2025
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code JOL·October 17, 2024
Wayne
FDA UDI
COOK INCORPORATED·00827002111820·Wayne Pneumothorax Set
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 10, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 6, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 25, 2025