13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNIWEB, VERSION 5.0
FDA 510(k)
FDA Class 2
·Radiology
Conmed/Linvatec
FDA UDI
Provision·00810041065834·
Conmed/Linvatec
FDA UDI
Provision·B504OM50711660·
NA
FDA UDI
STERILMED, INC.·10888551020497·SAW BLADE OSCILLATING LARGE BONE
ME-92
FDA UDI
Conmed Corporation·10845854002322·OSCILLATOR BLADE, ME-92 COATED, 32 X 64 X 0.8 M...
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021566·
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2024
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ULTRA V THERAPEUTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
COTTON TIPPED APPLICATOR, 6 INCH
FDA Adverse Event
Malfunction
·CITMED CORPORATION·Product code KXG·April 8, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 27, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 2008
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