9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
FDA 510(k)
FDA Class 2
·Neurology
QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·February 16, 2021
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 13, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JHS·May 11, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 29, 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