21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code GWF·February 20, 2018
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·December 2, 2013
NIM-ECLIPSE® PATIENT MODULE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·December 6, 2017
PROBE SPK1004 SURGEON CONTROLLED
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·May 17, 2013
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·December 14, 2015
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
COMPUTER NOTEBOOK (INTERNATIONAL
FDA Adverse Event
Malfunction
·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 27, 2013
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·June 17, 2008
FP KIT VI CELL XR QUAD PAK
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LDT·April 18, 2011
CONTROLLER ECLC ECLIPSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014
BD VACUTAINER SERUM BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 9, 2021
NIM-ECLIPSE PREAMPLIFIER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·July 7, 2021
COMPUTER NOTEBOOK (INTERNATIONAL)
FDA Adverse Event
Malfunction
·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·April 13, 2026
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015