7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ASO-CHECK
FDA 510(k)
FDA Class 1
·Microbiology
EXTRICARE NPWT FOOT DRESSING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 10, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024