7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
KS 5 - CLINICAL AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
Fix2Lock(PEEK Self Punching)
FDA 510(k)
FDA Class 2
·Orthopedic
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 24, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 28, 2013
MENTOR STYLE 1600 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR CORPORATION·Product code FWM·December 14, 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