8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
POWERHEART AECD
FDA 510(k)
FDA Class 3
·Cardiovascular
artegral life
FDA UDI
Merz Dental GmbH·D7091993533·anteriors; shade BL1; mould BM
WIN Flexible Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
FDA 510(k)
FDA Class 2
·Orthopedic
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·March 7, 2013
ENDOPATH STEALTH CIR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code KOG·February 16, 2011
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·August 8, 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