20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AC5 Topical Gel
FDA 510(k)
FDA Unclassified
·Unknown
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776165185·MEYERDING SKIN HOOKRETR -
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181866·Integra® Jarit® Meyerding Skin Hook and Retract...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812101·Littauer Cilia Forceps, Oblique, 9cm
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM
VIDAS® TSH
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code KLI·October 29, 2018
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
FDA 510(k)
FDA Class 2
·Cardiovascular
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 26, 2019
VIDAS® TSH
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code KLI·October 29, 2018
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·June 18, 2013
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 18, 2014
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 30, 2011
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 18, 2019
VIPER PRIME TORQUE HANDLE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code LXH·December 3, 2019
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 18, 2019
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 18, 2019
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 18, 2019
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020