22 results
·
20ms
·
Sources: EU EUDAMED, US FDA
IMPELLA CONTROLLER WITH FLOW CONTROL
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994155177·SCREW 8110845 BREAKOFF SET SCREW 10-32TI
JOBST SensiFoot
FDA UDI
BSN MEDICAL, INC.·00035664108458·SENSIFOOT 8-15 MM HG CREW EXTRA SMALL NAVY 1 EN...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819001·Single Hook malleable retractor w/Simpson Handl...
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642108903·Plate, 38 mm (W) x 13 mm (H)
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964090981·Trial Procedure Kit
MODIFICATION TO OSTEONICS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
MINIMAX STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025
MINIMAX RIGHT ANATOMICAL BROACH SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 14, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019
CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013