19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Transferrin
FDA 510(k)
FDA Class 2
·Immunology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319733332·Dingman Otobraders 5-1/2" (13.8cm), left & righ...
TRUEBALANCE BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540
FDA 510(k)
FDA Class 2
·General Hospital
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
GALAXY G3 MINI 2MM X 6CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·March 9, 2022
TRUE BALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·January 22, 2015
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·October 21, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE ? SINGAPORE·Product code FRN·August 4, 2011
REPLY
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L·Product code NVZ·June 21, 2013
BACT/ALERT MP - 419744
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·December 5, 2019
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