22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRYOSHAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TASMIN R 6°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014639·The basic shape of the TASMIN R devices is a ho...
MOBIS 0°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844001585·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P0609280·6mm PLIF Implant 9mm Wide 28mm Length
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609281·Mini Sprint-Brackets Roth .022" 200 Brackets
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P06092870·6mm PLIF Implant 9mm Wide 28mm Length, 7 deg Lo...
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 6, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 6, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 29, 2022
PROLITE VL PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
TIGER SPINE SYSTEM
FDA Adverse Event
Malfunction
·CORELINK, LLC.·Product code MNH·April 10, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 4, 2014
DST SERIES EEA ORVIL 25MM DEVICE
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GAG·June 13, 2008
BD INTERLINK¿ BLUNT PLASTIC CANNULA
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·September 24, 2018
3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.
FDA Recall
Terminated
·Product code ELZ·October 17, 2007
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022