13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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