17 results
·
24ms
·
Sources: EU EUDAMED, US FDA
SMARTLOG DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AGXO
FDA UDI
Oticon A/S·05707131260031·H110, MINIBTE 312 WL 85 CBE AGXO
DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
FDA 510(k)
FDA Class 2
·Dental
SPI EASY DENTAL IMPLANT PROTECTIVE CAP
FDA 510(k)
FDA Class 2
·Dental
PERIPHERAL NERVE BLOCK SUPPORT TRAY
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code CAZ·October 1, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·June 14, 2011
PUMP MMT-722 NAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 22, 2008
CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 2, 2014
CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 3, 2014
CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 1, 2014
PERIPHERAL NERVE BLOCK SUPPORT TRAY : CONTINUEOUS TRAY 100MM NEEDLE STIMULATING
FDA Adverse Event
Malfunction
·HALYARD - IRVINE·Product code CAZ·May 12, 2015
CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER
FDA Adverse Event
Malfunction
·HALYARD HEALTH - IRVINE·Product code CAZ·November 8, 2015
CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING
FDA Adverse Event
Malfunction
·HALYARD - IRVINE·Product code CAZ·July 1, 2015
ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU
FDA Adverse Event
Malfunction
·HALYARD·Product code CAZ·April 7, 2015
ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU
FDA Adverse Event
Malfunction
·HALYARD·Product code CAZ·April 7, 2015
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