41 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARESTREAM Vue PACS
FDA 510(k)
FDA Class 2
·Radiology
AGC Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304243057·
New Image
FDA UDI
HOLLISTER INCORPORATED·00610075078486·2-Piece Ostomy Skin Barrier, Convex, CeraPlus
Kirwan
FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019103845·Titanium Bipolar Coagulation Forceps 4 1/4" (10...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100295·FRANKEL INFANT EYE SPECULUM
PRESSON ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
INTERFACE
FDA 510(k)
FDA Class 2
·Dental
ONE TOUCH
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 15, 2002
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·August 25, 1999
CARELINK PROGRAM W/TELEMETRY C
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·June 8, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 22, 2011
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·September 8, 2008
RHK CEMENTED STEM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2019
RHK CEMENTED STEM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2019
ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
BIOMET OFFSET TIBIAL TRAY ADAPTOR
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2019
RHK 12X80 CEMENTED STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 9, 2019
RHK 10X80 CEMENTED STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 9, 2019
VNGD SSK PSC INTLK FMRL 60 RT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 30, 2022
VANGUARD SSK FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018