29 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPEQ ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LEONE SPA
FDA UDI
LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105050·Implant Inserter, 14-16mm, Sleeveless
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0105050·Inserter, Inline
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345027985·Lumbar Inserter, Rotate, 11-16H
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·April 21, 2010
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·April 26, 2010
STABILIT INTRODUCER
FDA Adverse Event
Injury
·DFINE INC.·Product code ---·July 16, 2009
TENDRIL ST
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·September 15, 2014
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 26, 2011
ADULT DUAL HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 23, 2010
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·December 29, 2015
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·July 3, 2017
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·January 4, 2018
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 1, 2018
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 23, 2018