3,182 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code CAW·March 19, 2014
Endoscopic Light-Projecting Measuring Device
FDA classification
FDA Class 2
·Endoscopic Light-Projecting Measuring Device
QTD PLASTICS
FDA registration
QTD PLASTICS·5 products·🇺🇸 United States
P300-1T-H
FDA UDI
NAKANISHI INC.·04589551354443·
Blue2 4th Generation
FDA UDI
Ablenet, Inc.·00186648000609·
Cannulated 1st MPJ Hemi Implant
FDA UDI
VILEX LLC·00841731106193·Cannulated Hemi Implant #2 17x15 Ti HA Coated...
Cannulated 1st MPJ Hemi Implant
FDA UDI
VILEX LLC·00841731106155·Cannulated Hemi Implant #1 15x13 Ti HA Coated...
PIGALILEO 4TH GENERATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PACS PLUS 5TH EDITION
FDA 510(k)
FDA Class 2
·Radiology
5TH METATARSAL FRACTURE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823103161·
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823102829·
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823102645·
Siemens Healthineers AG Varian Cancer Therapy (CTH)
FDA registration
Siemens Healthineers AG Varian Cancer Therapy (CTH)·7 products·🇩🇪 Germany
Access Total ßhCG (5th IS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS TOTAL BHCG (5TH IS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cobb-XLR Excellerator™
FDA UDI
5TH INTERVAL MEDICAL LLC·00860013965303·Suction cobb instrument for surgical procedures
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 24, 2014
Critical Cover
FDA UDI
Alpha Pro Tech, Inc.·10817583021868·Coverall, Microbreathe, White, Bound Seams, Bou...
Critical Cover
FDA UDI
Alpha Pro Tech, Inc.·10817583023053·Sleeve Protector, ComforTech, White, Sonic Weld...