15 results · 20ms · Sources: EU EUDAMED, US FDA

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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