15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
FDA 510(k)
FDA Class 2
·Ophthalmic
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACL TOP
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005
ACL TOP
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 26, 2024
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·April 23, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 29, 2011
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
MICROBORE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·December 22, 2017
MICROBORE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·December 22, 2017
MICROBORE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·December 20, 2017
MICROBORE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·December 22, 2017
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