20 results · 21ms · Sources: EU EUDAMED, US FDA

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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