13 results
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20ms
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Sources: EU EUDAMED, US FDA
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Mapleson Anesthesia Breathing Circuit
FDA UDI
MERCURY ENTERPRISES, INC.·10641043803813·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450573334·
D.SIGN 30
FDA 510(k)
FDA Class 2
·Dental
EXPANDABLE KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 29, 2026
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 26, 2013
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON·Product code FTL·May 6, 2011
SOFMED
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code ODR·July 22, 2008
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
1000317571-2021-00127
FDA Adverse Event
Injury
·CONVATEC LTD·Product code FRO·March 17, 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
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