8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DC-UIBC-CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AD/V SPOOLER
FDA 510(k)
FDA Class 1
·Radiology
THE KEYSTONE SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
TARGETING ARM T2 PROX. HUM.
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 27, 2012
MX40 1.4 GHZ SMART HOPPING
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·July 20, 2015
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
TENDRIL SDX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024