14 results
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19ms
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Sources: EU EUDAMED, US FDA
FIBRI-FILTER 20
FDA 510(k)
FDA Class 2
·General Hospital
Distance Holding Fork
FDA UDI
Innovative Orthopedic Technologies AG·03701602300020·Accessory to IOT ARCH LPS -- Distance Holding Fork
SWANSON
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420129093·
Halyard
FDA UDI
O&M HALYARD, INC.·20680651681304·HALYARD,H500,STRWRP,-,30X30,250
SleepmateVelstretch Band Small, Lt. Blue
FDA UDI
Ambu A/S·05707480041480·(Sleepmate item 1342)
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659443·Semi-automatic Disposable Biopsy Needle
WEGO-PGLA RAPID
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
METHADONE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 15, 2014
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO VILLALBA·Product code DTB·October 31, 2012
UNIVERSAL HIGH TORQUE DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·August 11, 2010
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023