27 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BBL™ Sensi-Disc™ Gentamicin 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902312277·BD BBL™ Sensi-Disc™ Gentamicin 10 µg
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021852·FPS 2.7mm Clearance Drill Bit
OsteoMed
FDA UDI
OSTEOMED LLC·00845694076487·FPS 2.7 Clearance Drill Bit Sterile Qty 2
PADSCAN HD SERIES BLADDER SCANNER
FDA 510(k)
FDA Class 2
·Radiology
LORDEX POWER TRACTION EQUIPMENT
FDA 510(k)
FDA Class 2
·Physical Medicine
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 8, 2003
NEEDLE,25GX1.5",REG,BEVEL
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES LP·Product code FMI·December 13, 2024
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 13, 2008
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 18, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025
BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·October 18, 2019
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022