27 results
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25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HAIRMAX LASERCOMB
FDA 510(k)
FDA Class 2
·Physical Medicine
2870 3WAY SLIDE VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750009015·2870L 3WAY MAN SLD VLV 1.375OD
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776180102·HEANEY TISSUE FORCEPS TEETH .IN
Disc Prep
FDA UDI
Life Spine, Inc.·00190837090081·
5112524
FDA Adverse Event
Malfunction
·September 30, 2015
MP 719
FDA 510(k)
FDA Unclassified
·Unknown
FUTURA
FDA 510(k)
FDA Class 2
·Physical Medicine
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·November 19, 2025
STONYBROOK HSP NY NY 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 25, 2011
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·April 25, 2019
C21785 IT TREVISO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code GEI·December 14, 2012
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 4, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·February 18, 2019