18 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Firstar Dental Unit
FDA 510(k)
FDA Class 1
·Dental
BD BBL™ Sensi-Disc™ Sulfisoxazole - 1.0 mg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312971·BD BBL™ Sensi-Disc™ Sulfisoxazole 1.0 mg
ELMED
FDA UDI
ELMED INCORPORATED·00842180161061·PRISM CERVICAL CURETTE 10" ANGLED 90° 6-0, RED
ACCESS OV MONITOR ASSAY
FDA 510(k)
FDA Class 2
·Immunology
SMARTRELEASE Endoscopic Soft Tissue Release System
FDA 510(k)
FDA Class 2
·Orthopedic
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·January 5, 2022
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 1, 2011
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
RIO 60 SECOND FACE LIFT TONER
FDA Adverse Event
Injury
·Product code ORU·July 11, 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
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018