14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
FDA 510(k)
FDA Class 2
·Neurology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780380030·Integra® Jarit® Rollet Retractor, 5-1/4", 4 Pro...
Bernafon
FDA UDI
Bernafon AG·05711584090282·ZERENA 3 MNR T FW 3.0
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812071·Buck Ear Curette - #4, Blunt, Straight: 14.5cm
CETRA
FDA UDI
Orthofix US LLC·18257200120277·1-LEVEL PLATE ASSEMBLY, 18MM
STIMTRODE SINGLE USE NERVE STIMULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC.·Product code MUJ·July 28, 2021
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·May 16, 2019
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013
PLMA DVC V11.51 1 R
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 18, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 30, 2011
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC·Product code MUJ·August 25, 2021
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016