14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809846355·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE MEDIUM K...
BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 10, 2018
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
FDA 510(k)
FDA Class 2
·Dental
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 31, 2010
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·April 11, 2013
ASR UNIT FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 7, 2011
ENDOWRIST PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GCJ·May 27, 2008
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018
OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012