13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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A-Line Advanced
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Sensi-Disc™ Ceftriaxone 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316351·BD BBL™ Sensi-Disc™ Ceftriaxone 30 µg
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022033·FPS 2.4mm Pilot/3.5mm CL Drill Guide Non-Locking
JMS ROTATING HUB A.V.FISTULA NEEDLE SET
FDA UDI
JMS SINGAPORE PTE LTD·08888483005215·A.V.FISTULA 16GX1" BE RH 30CM W/CLAMP
DEPUY ACROMED VBR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 14, 2008
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 1, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 12, 2013
BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022