10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088378·Box Cutter 11mm x 12mm
LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MINNIE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·December 21, 2012
SCREW GAUGE, LONG
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 14, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025