18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
CT/MR Ring & Tandem Set, 32mm Ring, 30ø, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020185·
CT/MR Ring & Tandem IU Tube, 30ø, 7cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020239·
CT/MR Ring & Tandem IU Tube, 30ø, 6cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020222·
CT/MR Ring & Tandem IU Tube, 30ø, 2cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020192·
CT/MR Ring & Tandem IU Tube, 30ø, 5cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020215·
CT/MR Ring & Tandem IU Tube, 30ø, 8cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020246·
CT/MR Ring Tube, 30ø, 32mm ring only, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020253·
CT/MR Ring & Tandem IU Tube, 30ø, 4cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020208·
IMPOAID
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
FDA 510(k)
FDA Class 2
·Radiology
SERIES A PAT W/WR THN 28 1 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 12, 2022
NANOTITE TM TAPERED CERTAIN IMPLANT 5 X 10MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·June 9, 2021
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·April 25, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020