109 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIGITAL RETINAL CAMERA
FDA 510(k)
FDA Class 2
·Ophthalmic
Redicare
FDA UDI
REDICARE LLC·B70901020130·Basic First Aid Kit for treating minor injuries...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746105715·DB BRACKET MINI MS MAND RIGHT 2ND BICUSPID 018 ...
Aveta Max+ Disposable Resecting Device, 3.9 mm
FDA UDI
MEDITRINA, INC.·00850006759729·Aveta Max+ Disposable Resecting Device, 3.9 mm,...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193108087·HA PEEK EVOS Straight, ,13mmx8mmx 30mm , FLAT ...
RHEAD
FDA UDI
Stryker GmbH·00886385024042·Stem Implant Plasma Coated, Size 4
OMNIPORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
FDA 510(k)
FDA Class 2
·Cardiovascular
2520274-2013-06036
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·September 5, 2013
2520274-2013-06034
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDO·September 5, 2013
BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·December 20, 2022
BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·December 20, 2022
BAND AID KPP REGULAR 10 2013
FDA Adverse Event
Injury
·SKILLMAN CONTRACT·Product code KGX·May 29, 2017
NORIAN REINFORCED FAST SET PUTTY/3CC
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code GXP·May 19, 2015
BD SYRINGE 20ML LL 120/PKG
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 23, 2021
2520274-2013-06033
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·September 5, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 3, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011
ARCHITECT I2000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code DHX·August 7, 2008
rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018