8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMPOREX
FDA 510(k)
FDA Class 2
·Dental
Brigade
FDA UDI
Nuvasive, Inc.·00887517963628·Brigade Lateral Trial, 13x38x28mm 30°
PARADIS VASO SHIELD
FDA 510(k)
FDA Class 2
·Cardiovascular
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 30, 2014
UNKNOWN NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·January 9, 2013
SPIDER - SINGLE PORT SURGICAL DEVICE
FDA Adverse Event
Malfunction
·TRANSENTERIX, INC.·Product code GCJ·August 31, 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