14 results · 22ms · Sources: EU EUDAMED, 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