9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857369610·Trial, Size 12x14x15 mm, 7°
RayPilot System
FDA 510(k)
FDA Class 2
·Radiology
ICE Ceramics, ICE Stains, Fresco
FDA 510(k)
FDA Class 2
·Dental
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
INJECTION GOLD PROBE BIPOLAR CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 25, 2008
6850 PROFX
FDA Adverse Event
Malfunction
·MIZUHO OSI·Product code JEB·July 29, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 11, 2014
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025