5 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
FDA Enforcement
Class II
·Ongoing·Mobius Imaging, LLC·January 25, 2023
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
FDA Enforcement
Class II
·Ongoing·Mobius Imaging, LLC·January 21, 2026
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
FDA Enforcement
Class II
·Ongoing·Mobius Imaging, LLC·January 21, 2026
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·May 28, 2014
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SHUNT PACK, REF PHS392834010D; 7) VP SHUNT, REF SYNJ10307A.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 8, 2025