14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Tapestry Biointegrative Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GENESIS II LONG STEM 10MMX70MM
FDA Adverse Event
Injury
·SMITH AND NEPHEW, INC.·Product code JWH·October 2, 2018
JOURNEY TIBIA BASE NP LT SZ 4
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 2, 2018
LEONE SPA
FDA UDI
LEONE SPA·08033707039303·DB BRACKETS 22 20VS A+6 CUS L/R
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002053·External 3.5mm x 6mm Flared Healing Abutment
AUDIOSCAN VERIFIT, MODEL VF-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SYNOVIS COLLAGEN MATRIX (TBD)
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 24, 2023
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 25, 2025
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIM·August 15, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
PINN MAR +4 10D 28IDX46OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 9, 2013
INJECTOR N35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·March 18, 2024
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023