21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dolphin/IQ and Dolphin/4D
FDA 510(k)
FDA Class 2
·Radiology
METAL OPAQUER
FDA 510(k)
FDA Class 2
·Dental
REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 18, 2022
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 31, 2025
BD VENFLON¿ PRO SAFETY IV CANNULA WITH INSTAFLASH¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 18, 2022
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 11, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 30, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 5, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 5, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 28, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·July 28, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 14, 2013
TENCKHOFF CATH (10)
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FJS·June 22, 2011
VIEWFLEX XTRA ICE CATHETER
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·April 27, 2022
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·September 30, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 12, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 10, 2025
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024