26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTENE CT, AOC CT, OSTEOTENE, CERETENE
FDA 510(k)
FDA Unclassified
·Unknown
Redicare
FDA UDI
REDICARE LLC·B70901020710·First Aid Kit intended for administering aid in...
Tasso Mini
FDA UDI
Tasso Inc.·00850038691134·
VARIANT
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1020710·Trial 26x32mm, 20° Lordotic, 17mm
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020710·SPIRA®-A Integrated,Trial, 28x38mm, 25° Lordoti...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973813·
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENT LASERVISION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISISTAT 35R 6/BOX
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDT·May 3, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 19, 2014
RSP SHOULDER
FDA Adverse Event
Malfunction
·ENCORE MEDICAL, L.P.·Product code HSD·April 14, 2011
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 27, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 11, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 19, 2022
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·August 9, 2016
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·November 9, 2016
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number U128, VALITUDE CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021