14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oscar Peripheral Multifunctional Catheter system
FDA 510(k)
FDA Class 2
·Cardiovascular
Avex CX
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205108081·Avex CX .018 LR3 (0°T 3°A)
NA
FDA UDI
Synthes GmbH·10886982153517·4.5MM CORTEX SCREW 38MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113829·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 X...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694020657·FPS 4.0mm x 38mm Standard Screw
HAWKEYE™ Vertebral Body Replacement (VBR)
FDA UDI
Choice Spine, LP·00840996100977·VBR,SPACER,12X14X38,0 DEG
OsteoMed
FDA UDI
OSTEOMED LLC·00845694074964·FPS 4.0 x 38mm Screw Sterile Qty 2
PYLORITEK VP TEST KIT 5140VP
FDA 510(k)
FDA Class 1
·Microbiology
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 7, 2025
ENDO ILS, 29MM, CURVED
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 30, 2014
FOUNDATION SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·August 2, 2011
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·July 3, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019