11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Puritan Bennett
FDA UDI
Covidien LP·20884521134444·Calibration Shell,For Soft Headgear CPAP Interf...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022057·FPS Mini Screwdriver, Ratchet Body, Cannulated
IsoLED II LED HL
FDA UDI
Medical Illumination International Inc.·00816835023998·IsoLED II LED HL, w/ AC Power Pack
EVEREST Spinal System
FDA UDI
VB Spine LLC·10888857348035·Driver, Height Adjustment Size 25 (Long)
K SERIES CPAP SYSTEMS
FDA 510(k)
FDA Class 2
·Anesthesiology
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATLAS II PLUS DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 1, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022