22 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
FDA 510(k)
FDA Class 1
·General Hospital
BD BBL™ Sensi-Disc™ Triple Sulfa - 0.25 mg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902313497·BD BBL™ Sensi-Disc™ Triple Sulfa - 0.25 mg
24M - Tampa Electric Co.
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.
OTP 1.2
FDA 510(k)
FDA Class 2
·Radiology
Smith+Nephew Arthroscopes
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·July 22, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 10, 2025
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWA·July 26, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 17, 2013
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026