10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
ULTRASTIM KIT
FDA 510(k)
FDA Class 2
·Neurology
HARDY DISK, CEFPODOXINE, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 29, 2024
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 23, 2013
REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·May 2, 2011
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
E-LUMINEXX BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·November 17, 2015
E-LUMINEXX BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·August 16, 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