17 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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