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

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CrossTIE Intraosseous Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

HHM

FDA UDI
Oticon A/S·05707131288059·H330V2, DESIGNRITE 10 WL CRED HHM

Light Cure Adhesive

FDA UDI
TP ORTHODONTICS INC·00192029000083·ADHESIVE, BRACKET-Tooth Conditioner, Resin

Prolift Post-Pack Instruments

FDA UDI
Life Spine, Inc.·00190837031923·

Sklar®

FDA UDI
SKLAR CORPORATION·10649111134036·DISSECTING SCISSORS STR 4 1/4"

REUSABLE STIMULATING ELECTRODES

FDA 510(k)
FDA Class 2 ·Neurology

SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311

FDA 510(k)
FDA Class 2 ·General Hospital

TRULIANT TIB IMP PSC INSERT SZ 6, 15MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 11, 2024

SPRINTER LEGEND RX

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code LOX·June 7, 2013

ACCU-CHEK ® MOBILE TEST STRIPS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code LFR·October 8, 2014

ASR UNI FEMORAL IMPL SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011

ALK (D5F3)

FDA Adverse Event
Malfunction ·VENTANA MEDICAL SYSTEMS INC.·Product code NJT·August 22, 2025

TRULIANT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·July 24, 2024

ADVANCED PATELLA 29M 3 PEG IMPLANT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 15, 2024

TRULIANT TIB IMP PS INSERT SZ 2.5 11MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 14, 2023

ADVANCED PATELLA 32MM 3 PEG IMPLANT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·March 19, 2025

TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 19, 2023

TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 6, 2023

ADVANCED PATELLA 35MM 3 PEG IMPLANT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·January 9, 2024

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016