7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFETY TROCER WITH SPRINGLOADED OBDURATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
FDA 510(k)
FDA Class 2
·Radiology
B&L L-BETA, MODEL WL-B1
FDA 510(k)
FDA Class 1
·Dental
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·February 8, 2013
CSF-FLOW CONTROL VALVE, BURR HOLE, 12MM, MEDIUM PR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·December 16, 2010
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 15, 2014
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025