10 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C
FDA 510(k)
FDA Class 2
·Cardiovascular
Lacrimal Probe
FDA UDI
KATENA PRODUCTS, INC.·00841668108826·JACKSON LACRIMAL INTUBATION SET
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
FDA 510(k)
FDA Class 2
·Immunology
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·EES-ALBUQUERQUE·Product code GDO·May 23, 1997
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·February 21, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 13, 2011
MBT TIBIAL IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL LTD. 8010379·Product code LXH·August 1, 2014
TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·November 7, 2022
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