11 results
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20ms
·
Sources: EU EUDAMED, US FDA
Tria Sapphire
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PREVENA INCISION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 7, 2011
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 6, 2021
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022