13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SCOPEVALET DISPOSABLE BIOPSY VALVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K2M General Instruments
FDA UDI
VB Spine LLC·10888857553989·Parallel Trial Size 11x30x11 mm
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 23, 2023
VARIOUS
FDA 510(k)
FDA Class 2
·Orthopedic
CARE STIM
FDA 510(k)
FDA Class 2
·Neurology
CODA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·October 23, 2017
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 21, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·September 18, 2014
JAGTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·June 13, 2011
CODA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·September 10, 2019
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017