11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
VITAL CONNECT 4.0
FDA 510(k)
FDA Class 2
·Radiology
NDH MEDICAL, INC.
FDA registration
NDH MEDICAL, INC.·3 products·🇺🇸 United States
K.E.A.T.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
FDA 510(k)
FDA Class 2
·Radiology
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·April 16, 2013
PUMP IN STYLE ADVANCED
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·March 17, 2011
MODEL 91341, TELEMETRY TRANSMITTER 1400 MHZ
FDA Adverse Event
Malfunction
·SPACELABS MEDICAL INC.·Product code DSI·June 13, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015