22 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Jada System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
7930 MASK
FDA UDI
HANS RUDOLPH, INC.·00874750005208·ADULT MED M/F MASK/SMC FLOWMTR
IMF SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036090692·
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·May 14, 2024
PRIMECHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 13, 2015
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 24, 2024
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·January 14, 2016
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 17, 2015
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·January 29, 2016
CARESCAPE MONITOR B850
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·July 29, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 27, 2014
T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·July 2, 2013
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 13, 2024
BD PHASEAL OPTIMA INJECTOR (N40-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 16, 2024
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021
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