9 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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I-STAT KAOLIN ACT TEST
FDA 510(k)
FDA Class 2
·Hematology
MAYBE?MOM MINI OVULATION MICROSCOPE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
FDA 510(k)
FDA Class 2
·General Hospital
NEUTRAL LINER 32 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OQI·October 8, 2018
SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·October 8, 2018
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·March 27, 2013
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·January 21, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 1, 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