9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PFM-90 CEILING TUBE SUPPORT
FDA 510(k)
FDA Class 1
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777662·LUMBAMED BASIC DORSAL STAYS M SILVER IV
3M™ Unitek™
FDA UDI
3M COMPANY·30605861027855·3M™ Unitek™ Stainless Steel Second Primary Mola...
SPECTRA SYSTEM DENTAL IMPLANTS 2008
FDA 510(k)
FDA Class 2
·Dental
HM-LAMP II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 7, 2013
HEMOCHRON JR SIGNATURE SYSTEM
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·October 25, 2010
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015