10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MILENIA BETA-2 MICROGLOBULIN
FDA 510(k)
FDA Class 2
·Immunology
Tecomet
FDA UDI
TECOMET INC.·00841435108141·Punch, 90°, 3.2mm, Left, Rotary Loop
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756981194·MAJOR GENERAL PACK
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100520·Caddie, 6.5mm Screws
Radio Frequency Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BASIX COMPAK INFLATION SYRINGE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS LTD.·Product code DXT·November 16, 2012
BIPOLAR LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·November 10, 2010
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 2, 2014
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021