17 results · 24ms · Sources: EU EUDAMED, US FDA

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HONOUR SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517636430·CoRoent Ant TLIF PEEK, 12x10x34mm 15°

Apex

FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584917·Apex Tibial Nail Ø 12 x 345mm

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450295045·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970508·

Truliant

FDA UDI
Exactech, Inc.·10885862314925·Truliant PS Porous Femoral

ARTHREX UNIVERS FRACTURE PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

SYSTEMS INTEGRATION MODEL: ENDOALPHA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 20, 2013

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
ANI [ A&I ] GROUP TAIWAN·Product code IOR·September 26, 2014

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS LLC (PR)·Product code NIQ·June 10, 2011

TRULIANT POR TIB TRAY SIZE 4.5F/3.5T

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 25, 2022

UNITIP CATHETER FOR HR GI

FDA Adverse Event
Malfunction ·UNISENSOR USA INC·Product code FFX·January 16, 2015

TRULIANT TIB IMP PS INSERT SZ 4.5 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 29, 2026

BAIR HUGGER / 3M

FDA Adverse Event
Injury ·3M·Product code DWJ·November 23, 2016

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015