8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
THE BIOPLATE SHUNT CONNECTOR
FDA 510(k)
FDA Class 2
·Neurology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984583·anteriors; shade C4; mould 101
BTE HEARING AID SIEMENS MODEL 284PP-ASP
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONO-VU US(TM)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ATLAS PLUS VR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·February 28, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 11, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 6, 2014
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