8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CALCIMOL
FDA 510(k)
FDA Class 2
·Dental
NEW COMFORT-FIT DENTAL GUARD
FDA 510(k)
FDA Unclassified
·Unknown
FREEDOM
FDA 510(k)
FDA Class 1
·Physical Medicine
REPAIR CORE SABER DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·December 7, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·January 22, 2013
STERRAD 200, SINGLE DOOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 9, 2014
OPTETRAK ASY, HI-FLEX PS CEM FEM, SZ 4, RIGHT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 29, 2023
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024