22 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
FDA Enforcement
Class I
·Ongoing·National Distribution & Contracting Inc·October 20, 2021
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
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.
FDA Enforcement
Class I
·Ongoing·Insulet Corporation·January 10, 2024
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
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·September 24, 2025