11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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V-Mix
FDA 510(k)
FDA Unclassified
·Unknown
Contrast Line
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207411·Contrast Line 48"(122cm) Female/Rotating Adapte...
ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·February 18, 2005
LIFEBRIDGE
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GEMINI PAIRED WIRE HELICAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FFL·October 7, 2008
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·June 27, 2013
VISION SINGLE CHAMBER WASHER
FDA Adverse Event
Injury
·STERIS CANADA CORPORATION·Product code MEC·August 5, 2011
HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 7, 2024
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018