11 results
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27ms
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Sources: EU EUDAMED, US FDA
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
FDA 510(k)
FDA Class 1
·General Hospital
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083011277·Fixed, 10 electrode, MPB, 2mm electrode spacing
ERA 3.25MM IMP 0DEG MICRO HEAD 10X1MM, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108327·Designed for both transitional and long-term de...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746110917·DB BKT MINI MS LL CUSP 018 T=0 A+3 R=0
n/a
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978079462·INSERTER 901-522 MD-IV 22MM
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
TRANSQ3
FDA 510(k)
FDA Class 2
·Physical Medicine
XENON 300
FDA Adverse Event
KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code GCT·June 23, 2014
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·January 3, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 9, 2010
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