15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMO-CATH SILICONE DOUBLE LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ReLine
FDA UDI
Nuvasive, Inc.·00195377035233·RELINE-C Compressor
Trimline
FDA UDI
ORMCO CORPORATION·00889989052657·LOWER LEFT SECOND MOLAR TRIMLINE BAND SIZE 29
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189718·AK3 Patella Lateral Hole Drill Guide
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·EXCELENS (ATLAFILCON A) CONTACT LENS
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLUID, RHEMOX W LYSING
FDA 510(k)
FDA Class 1
·Hematology
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·EXCELENS (ATLAFILCON A) CONTACT LENS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBA 2000(TM) (ATLAFILCON A) SOFT CONTACT LENS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·EXCELENS (ATLAFILCON A) CONTACT LENS
HALO
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code LXH·May 21, 2026
PROXIMATE CIRCULAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 24, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·November 1, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012
Bivona Uncuffed Wire Endotracheal Tubes,
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021