13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012833·Zirlux 16+ B1 95X30
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112440·Awl Tap, 6.5 mm, Fixed Sleeve
HAC-300 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
FDA 510(k)
FDA Class 1
·General Hospital
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 24, 2025
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·July 30, 2010
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·August 22, 2024
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·March 20, 2013
PELORIS RAPID TISSUE PROCESSOR
FDA Adverse Event
Malfunction
·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·February 9, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·March 11, 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
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012