11 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
FDA Enforcement
Class II
·Ongoing·DEPUY (IRELAND)·May 6, 2026
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025