12 results
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25ms
·
Sources: EU EUDAMED, US FDA
BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B
FDA 510(k)
FDA Class 2
·General Hospital
Acetabular reamer ø51mm
FDA UDI
Incipio Devices SA·07630055302779·Acetabular reamer for hip arthroplasty
LACTOSORB® SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304416291·
Barco
FDA UDI
FIMI SRL·05415334002241·MDRC-2321 HNIB
Stainless Steel Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746115707·COSMETIC BRACKET LINGUAL MAX CENTRAL/LATERAL 01...
ARMAND ENDOSCOPE HOLDER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Exilite
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 27, 2014
TRILOGY SHELL SPIKED
FDA Adverse Event
Injury
·ZIMMER·Product code LPH·February 6, 2013
POLESTAR INTEGRATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 7, 2010
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014