7 results
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18ms
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Sources: EU EUDAMED, US FDA
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
FDA 510(k)
FDA Class 2
·Immunology
DE-BOND 200
FDA 510(k)
FDA Class 1
·Dental
CPR MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
LOCKSCR Ø5 SELF-TAP L60 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·February 28, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011
LASIK
FDA Adverse Event
Other
·Product code LZS·August 1, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024