20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SLIT LAMP ATTACHMENT
FDA 510(k)
FDA Class 2
·Ophthalmic
ACUMED
FDA UDI
Acumed LLC·10806378052033·4.0mm Cannulated Hex Screw Driver
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136810·
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
FDA 510(k)
FDA Class 2
·Ophthalmic
OCCLUSION BALLOON CATHETER MODEL OBC
FDA 510(k)
FDA Class 2
·Cardiovascular
TUMESCENT INFILTRATION PUMP
FDA Adverse Event
Malfunction
·COVIDIEN PLYMOUTH·Product code FRN·May 9, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 23, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·January 13, 2015
BUTTRESS/COMPRESSION NUT FOR 357.369
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HST·January 13, 2015
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·January 13, 2015
BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·January 13, 2015
11.0MM/3.2MM WIRE GUIDE 222MM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code FZX·January 13, 2015
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code LXH·January 13, 2015
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code FZX·October 25, 2016
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code FZX·October 25, 2016
BUTTRESS/COMPRESSION NUT FOR 357.369
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HST·September 13, 2016
BUTTRESS/COMPRESSION NUT FOR 357.369
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HST·September 13, 2016
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024