8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MIN-R CASSETTE
FDA 510(k)
FDA Class 2
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293913·
STERILIZER, SERIES 3000, MODIFICATION TO
FDA 510(k)
FDA Class 2
·General Hospital
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
FDA 510(k)
FDA Class 2
·Radiology
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·October 4, 2012
ACRYSOF IQ RESTOR SINGLEPIECE IOL
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. - HUNTINGTON·Product code MFK·May 14, 2015
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNQ·July 27, 2010
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024