11 results
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26ms
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Sources: EU EUDAMED, US FDA
CONTROL 1 ENVIRONMENTAL CONTROL
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814695·GENUMEDI SILVER SIZE VI
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123281·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 150mm
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7404902206·Rampart One Oblique Trial, 12mm, M, 8°
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
FDA 510(k)
FDA Class 2
·Cardiovascular
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
FDA 510(k)
FDA Class 2
·Cardiovascular
TORNIER
FDA Adverse Event
Malfunction
·TORNIER INC·Product code HTW·November 9, 2010
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code OUT·January 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014
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