11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 2, 2024
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACUGLIDE BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 21, 2025
LIAISON TREPONEMA ASSAY
FDA Adverse Event
Other
·DIASORIN S.P.A.·Product code LIP·April 8, 2013
CONMED NEONATAL ECG ELECTRODE W/LEADWIRE
FDA Adverse Event
Other
·CONMED CORPORATION·Product code DRX·July 22, 2008
MAXGUARD ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·April 27, 2011
SYRINGE 1ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 5, 2021
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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