8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
COLD LIGHT SOURCE LOS 150
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122765·K-WIRE - SINGLE TROCAR THREADED 1.8mm DIA x 230mm
DeGen Medical Patient Specific Implant (PSI) System
FDA 510(k)
FDA Class 2
·Orthopedic
Atlas SPEEDER Header/Neck
FDA 510(k)
FDA Class 2
·Radiology
REVEAL XT
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DSI·February 9, 2013
BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
FDA Adverse Event
Death
·C.R. BARD, INC. (BEP)·Product code LDF·December 23, 2010
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024