22 results · 25ms · Sources: EU EUDAMED, 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