14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
FDA 510(k)
FDA Class 2
·Cardiovascular
TOKUYAMA REBASE II
FDA 510(k)
FDA Class 2
·Dental
FAS ENDOLUMINAL BRUSH
FDA 510(k)
FDA Class 2
·General Hospital
MARGRON STEM (K032641)
FDA Adverse Event
Injury
·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005
ACCU-CHEK ® TENDER INFUSION SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·April 29, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 11, 2014
PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BSC LETTERKENNY·Product code LIT·July 23, 2008
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·June 27, 2024
DHS®/DCS® WRENCH
FDA Adverse Event
Injury
·SYNTHES HAGENDORF·Product code HXC·January 13, 2016
DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code KTT·January 13, 2016
DHS®/DCS® GUIDE SHAFT WITH FLATS
FDA Adverse Event
Injury
·SYNTHES USA·Product code FZX·January 13, 2016
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 13, 2025
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