17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MINI VP1 (PL67_F); MINI VP1 (PL61_F)
FDA 510(k)
FDA Class 2
·Ophthalmic
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813058565·STERILE CARBIDE BUR FG2SURG
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780189282·Integra® Jarit® Lane Elevator, 7-3/4", 7mm Wide
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
FDA 510(k)
FDA Class 2
·General Hospital
IMP,TSV,3.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 10, 2022
IMP,TSV,3.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 9, 2024
IMP,TSV,4.1,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 2, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 14, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 15, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·July 26, 2013
G7 E1 LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 14, 2018
G7 HI-WALL E1 LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 14, 2018
G7 MULTIHOLE SHELL
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·June 14, 2018
BD POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·July 25, 2025
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013