8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTOMY APPLIANCE W/DEODORIZING FILTER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
EVOLVE EPS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Extended Lipid Panel Assay
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 30, 2014
MITEK FMS DUO PUMP
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HRX·October 10, 2012
INFUSOR SINGLEDAY 2ML/HR 12PK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 3, 2010
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
FDA Recall
Terminated
·3-D Matrix, Inc.·Product code NHB·December 2, 2019
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022