12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
FDA 510(k)
FDA Class 1
·General Hospital
JOINT
FDA UDI
Aktormed GmbH·04260463844825·autoclavable accessories for the DEXTER ENDOSCO...
Oticon
FDA UDI
Oticon A/S·05707131376190·OPN S 1, MINIRITE 312 2.4G NFM PB C094
SELECTRA SLITTER TOOL
FDA 510(k)
FDA Class 2
·Cardiovascular
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDLINE UNITE
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2011
PROLENE POLYPROPYLENEMESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 9, 2013
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023