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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Bi-Portal Bone Graft Delivery Device
FDA 510(k)
FDA Class 2
·General Hospital
VIZION DR
FDA 510(k)
FDA Class 2
·Radiology
NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 13, 2023
BD INSYTE AUTOG BC PNK 20GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 14, 2024
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·February 20, 2013
LC PCA HOSPIRA MEDNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·September 26, 2014
CONTOUR TS TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·June 21, 2011
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
FDA Enforcement
Class II
·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 25, 2023
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015