11 results
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25ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO HAMILTON-G5
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189706·LEVAMED ACTIVE ANKLE SUP BLACK L I
PALODENT PLUS FORCEPS
FDA Adverse Event
Malfunction
·DENTSPLY LLC·Product code DZN·November 14, 2022
ORTHO VLC; ORTHO VLC CAPSULE
FDA 510(k)
FDA Class 2
·Dental
SOFTSENS
FDA 510(k)
FDA Class 2
·Neurology
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
JUNCHENG·Product code ITJ·April 29, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 19, 2011
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LIT·July 25, 2008
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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