15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEUROTECH PLUS
FDA 510(k)
FDA Class 2
·Neurology
2870 3WAY SLIDE VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750008407·2870 3WAY 22MMOD MP/22MMOD BAG
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122230·KWire .045x9" (1.1x225mm)
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857235496·Template Holder
COMPANION MODEL 221, 321, 421
FDA 510(k)
FDA Class 2
·Physical Medicine
CUSA NXT EXTENDED LENGTH TIP
FDA 510(k)
FDA Unclassified
·Unknown
IMP TM 4.7MM MTX FULL, 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 27, 2024
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2024
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 23, 2014
UNKNOWN
FDA Adverse Event
UNKNOWN·Product code GCJ·March 24, 2006
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 29, 2011
IMP TM 4.7MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 30, 2024
IMP TM 6.0MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 29, 2023
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
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021