16 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOFILAMENT POLYPECTOMY SNARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925016521·PISTON WITH ARMSTRONG PLATINUM RIBBON LOOP .6MM...
RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 26, 2019
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
NAVI XIA MODULAR TAP 5.5MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code HAW·March 30, 2015
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX LLC·Product code FPA·October 30, 2017
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
STAR S4 IR EXCIMER LASER
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code LZS·May 31, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 15, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·September 3, 2008
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·January 9, 2024
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014