17 results
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8ms
·
Sources: EU EUDAMED, US FDA
VAPORIZER VICKS 1.5GAL Item Number: 2354942
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
FREESTYLE LANCETS 28G 100CT Item Number:2975670
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
FDA Enforcement
Class II
·Ongoing·Resource Optimization & Innovation Llc·November 29, 2017
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
FDA Enforcement
Class II
·Ongoing·Hologic, Inc·May 20, 2026
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
FDA Enforcement
Class II
·Ongoing·Hologic, Inc.·March 1, 2023