7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DMA LD KINETIC PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENAMEL ETCHING GEL
FDA 510(k)
FDA Class 2
·Dental
HALE SUN SURGICAL TOWEL OR O.R. TOWEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THUNDERBEAT 5MM, 35CM, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEM CORP·Product code GEI·June 12, 2014
BATTERY 14.8V, 6.3 AH LI-ION BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 15, 2015
LCS 3PEG MOD ROT PAT CEM STD+
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·January 15, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024