8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088576·Paddle Distractor, 9mm
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 29, 2013
FLEXIMA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FFA·December 20, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 14, 2014
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