10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033980·Baltic Denture System BDLoad BDLoad Sm7 PLSEbm...
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 4, 2023
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 3, 2013
MBT CEM KEEL TIB TRAY SZ3
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISON OF DEPUY ORTHOPAEDICS·Product code NJL·March 17, 2011
EXTENSION ROD
FDA Adverse Event
Injury
·ABBOTT SPINE·Product code LXH·April 24, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024