9 results
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18ms
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Sources: EU EUDAMED, US FDA
MODIFICATION PROSPECT GIARDIA RAPID ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Accu-Beam
FDA UDI
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL·B1779208170·Re-usable fiberoptic handpiece for lasers.
17ga...
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110928·STERILIZING CASE SINGLE VR
LIQUICHEK URINE CHEMISTRY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
FDA 510(k)
FDA Class 2
·Immunology
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·January 17, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTL., LTD. 8010379·Product code JDI·July 8, 2014
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