7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KALLESTAD HEP-2 CELL LINE SUBSTRATE
FDA 510(k)
FDA Class 2
·Immunology
FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)
FDA 510(k)
FDA Class 1
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 2, 2007
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
FDA Enforcement
Class II
·Terminated·Ambu Inc.·March 30, 2016