13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Smile Dx®
FDA 510(k)
FDA Class 2
·Radiology
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272424371·Molt 9 Simple Dental Periosteal Elevator ARTMAN
NA
FDA UDI
Medos International Sàrl·10886705028610·Coupler, Autoclavable 19 mm Focal Length
Infusion Sets for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
DORSAL INTRAMEDULLARY PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
IMP,TSV,MCOL MG,3.7MM,8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 9, 2024
IMP,TSV,MCOL MG,3.7MM,8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 29, 2025
IMP,TSV,MCOL MG,3.7MM,8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 29, 2025
ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·August 4, 2020
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2013
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020