19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Posterior Fusion Plate, HA Posterior Fusion Plate
FDA 510(k)
FDA Class 2
·Orthopedic
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040187678·ZIRLUX ML DISC A3.5 98x18
IBP Interface cable (PvB X-trans - PvB – Codan)
FDA UDI
MIPM Mammendorfer Institut für Physik und Medizin GmbH·04255629200706·
IBP Interface cable (PvB X-trans - PvB – Codan)
FDA UDI
MIPM Mammendorfer Institut für Physik und Medizin GmbH·EMIP52000660·
STEVENS TENOTOMY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083547·STEVENS TENOTOMY SCISSORS BLUNT CURVED BLADES P...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694005937·1.0mm Pilot Drill, 4mm Stop, Dental Latch
ADSON NELMS FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059467·ADSON NELMS FORCEPS SERRATED HANDLE
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
FDA 510(k)
FDA Class 2
·General Hospital
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 15, 2008
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·August 10, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 1, 2013
AMPLATZER PFO OCCLUDER
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code MLV·November 22, 2022
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 15, 2017
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 7, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2015
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·September 22, 2016
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014