10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline Surgical Face Mask and Medline Procedural Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232369·
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
FDA 510(k)
FDA Class 1
·General Hospital
SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 16, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·July 12, 2013
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·August 29, 2012
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025