9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MULTIPLE
FDA 510(k)
FDA Class 1
·Ophthalmic
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088637·Paddle Distractor, 15mm
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
IOVERA
FDA 510(k)
FDA Class 2
·Neurology
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
ADVIA CENTAUR HBSAG
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code LOM·December 15, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 14, 2014
FLUOROSCOPY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 21, 2012
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