15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OSTEOMED HAND FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Bernafon AG·05711584004586·CT7 CPX, VC PS MAC CANTEO 7
MAXCUT CARBIDE BUR (10/pk) FG 701
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114191·MAXCUT CARBIDE BUR (10/pk) Shape: Cross Cut Tap...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089448715·
MILLENNIUM
FDA Adverse Event
Malfunction
·AVALIGN TECHNOLOGIES, INC.·Product code HTW·November 15, 2023
ENSITE VELOCITY SYSTEM, MODEL EE3000
FDA 510(k)
FDA Class 2
·Cardiovascular
CAVEX COLORCHANGE
FDA 510(k)
FDA Class 2
·Dental
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025