8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED AML + ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MODEL 30 CLASSIC PNEUMATONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
STOCKERT S3 ROLLER PUMP MODULE STOCKERT SE CONSOLE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·June 24, 2014
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·January 8, 2013
ESCHMANN EASY LIFT SHOULDER POSITIONER
FDA Adverse Event
Other
·ALLEN MEDICAL SYSTEMS·Product code FWZ·November 12, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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