12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
FDA 510(k)
FDA Class 2
·Immunology
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
FDA 510(k)
FDA Class 2
·Microbiology
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
FDA 510(k)
FDA Class 2
·Neurology
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X360MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code JDS·October 11, 2012
LTV 1200 VENTILATOR
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL, INC·Product code CBK·November 13, 2023
NO CODE AVAILABLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code GXN·March 8, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
OPTISENSE
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 11, 2011
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008
LTV 1200 VENTILATOR
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL, INC·Product code CBK·December 13, 2023
PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code GWO·June 21, 2016
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