9 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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TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10888277906426·DRESSING CHANGE KIT
SURGISIS, SURGISIS ES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Kuschall Advance Manual Wheelchair
FDA 510(k)
FDA Class 1
·Physical Medicine
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·October 8, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·December 10, 2012
RX PERMANENT PACING LEAD
FDA Adverse Event
Injury
·OSCOR INC.·Product code DTB·November 19, 2021
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026