14 results · 21ms · Sources: EU EUDAMED, 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