14 results · 22ms · Sources: EU EUDAMED, US FDA

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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