14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infant Heel WarmerTM; Heel Snuggler®
FDA 510(k)
FDA Class 1
·Physical Medicine
Life Instruments
FDA UDI
Life Instrument Corporation·M930722115430·Micro Axial Cobb Elevator 4mm Sharp
GOLDWAY PATIENT MONITOR, MODEL # UT4000F
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRASONIC NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
PALINDROME 19/36 KIT W/ SLOT
FDA Adverse Event
Malfunction
·COSTA RICA·Product code MSD·November 3, 2014
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 24, 2011
ALENTI
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·July 5, 2013
GRAFTS ADVANTA VXT W/GDS
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORPORATION·Product code DSY·April 3, 2023
GRAFTS ADVANTA VXT W/GDS
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORPORATION·Product code DSY·May 1, 2023
GRAFTS ADVANTA VXT W/GDS
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORPORATION·Product code DSY·April 3, 2023
GRAFTS ADVANTA VXT W/GDS
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORPORATION·Product code DSY·April 30, 2023
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016