11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EyeGility Inserter for Preloaded enVista IOLs
FDA 510(k)
FDA Class 1
·Ophthalmic
NA
FDA UDI
Medos International Sàrl·10886705028856·LIGHT GUIDE, UNIVERSAL 3.5MM X 3.0M
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423891·Rubber Dam Kit with 12 Black Anti reflection Cl...
Variolink Esthetic
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·September 4, 2025
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·February 9, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
GYNECARE TVT EXACT CONTINENCE SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·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