34 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
M-ARS ACL: Anatomic Ribbon Surgery System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100776·FLIERINGA FIXATION RING 16MM
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM
PRECISION FLOW(R) - HELIOX
FDA 510(k)
FDA Class 2
·Anesthesiology
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
FDA 510(k)
FDA Class 2
·Neurology
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·March 30, 2026
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 24, 2026
PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 14, 2017
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
OPTIPAC 80 REFOB PLUS BONE CMT-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·March 17, 2026
TOTAL ASR FEM IMP SIZE 59
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·October 14, 2014
REDUC-FORCEPS TOOTHED SOFTLO L250
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·June 15, 2013
CARPENTIER-EDWARDS® PHYSIO II ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·July 21, 2011
PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 8, 2017
REFOBACIN BONE CEMENT R 2X40G
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBB·March 12, 2026
REFOBACIN BONE CEMENT R 2X20-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 11, 2026
PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·October 10, 2017
REFOBACIN BONE CEMENT R 2X40G
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 20, 2026
OPTIPAC 80 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·November 14, 2025
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Death
·BIOMET FRANCE S.A.R.L.·Product code MBB·December 15, 2025