13 results · 21ms · Sources: EU EUDAMED, US FDA

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AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

1000317571-2021-00127

FDA Adverse Event
Injury ·CONVATEC LTD·Product code FRO·March 17, 2021

Aligned Medical Solutions

FDA UDI
Aligned Medical Solutions·B09800803830·Arthrogram Tray - RX

Mapleson Anesthesia Breathing Circuit

FDA UDI
MERCURY ENTERPRISES, INC.·10641043803837·

TEMP SCAN

FDA 510(k)
FDA Class 2 ·General Hospital

ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED

FDA 510(k)
FDA Class 2 ·Orthopedic

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 6, 2011

MERCI RETRIEVER V 2.5 FIRM

FDA Adverse Event
Injury ·CONCENTRIC MEDICAL, INC.·Product code NRY·July 22, 2008

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025

MEDISLIM

FDA Adverse Event
Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015