12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Parcus Synd-EZ SS
FDA 510(k)
FDA Class 2
·Orthopedic
Lockheed - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal
ELMED
FDA UDI
ELMED INCORPORATED·00842180135635·5MM DIA., 45CM, ELMED BARIATRIC LAPAROSCOPE, 45...
n/a
FDA UDI
Ortho Development Corporation·00822409068029·Slotted Stem Trial 22x150mm
Echotip
FDA UDI
COOK INCORPORATED·00827002163102·Echotip Disposable Amniocentesis Needle
SYNTHES CURVILINEAR DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OSCAR, MODEL OE3000
FDA 510(k)
FDA Class 2
·Orthopedic
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·November 5, 2008
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·August 24, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 2, 2013
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 8, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025