8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORAIL Cemented Femoral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
TIPCAM1 Rubina Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SFI-BAR
FDA 510(k)
FDA Class 2
·Dental
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 22, 2011
OCTRODE
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 12, 2013
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Enforcement
Class I
·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022