12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ASCON SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·Ophthalmic
Symmetry Metzenbaum
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482127698·Symmetry® Scissors, Metzenbaum, Curved, Serrate...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209113040·
OsteoCool V-3 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
KYPHON BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019
1030489-2019-01423
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019
CITATION TMZF HA STEM #3 RIGHT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 5, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 4, 2010
12.0MM CANNULATED DRILL BIT LARGE QC/190MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·November 30, 2012
OSTEOCOOL RF ABLATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020
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