16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Enteral Feeding Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LCP
FDA UDI
Synthes GmbH·10886982164490·4.5MM LCP PROXIMAL TIBIA PLATE 6 HOLES/118MM-LEFT
Vagus Nerve Stimulator For Rheumatoid Arthritis
FDA Pre-Market Approval
FDA Class 3
·SetPoint System
POLYCRYL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Vagus Nerve Stimulator For Rheumatoid Arthritis
FDA Pre-Market Approval
FDA Class 3
·SetPoint System
Vagus Nerve Stimulator For Rheumatoid Arthritis
FDA Pre-Market Approval
FDA Class 3
·SetPoint System
I-STAT EG7+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 9, 2024
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 29, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 8, 2011
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·BARD SHANNON LTD·Product code FTL·July 18, 2013
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 23, 2024
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Malfunction
·AGA MEDICAL CORPORATION·Product code MLV·November 16, 2020
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Malfunction
·AGA MEDICAL CORPORATION·Product code MLV·November 16, 2020
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Malfunction
·AGA MEDICAL CORPORATION·Product code MLV·November 16, 2020
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013