23 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·February 8, 2023
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
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·February 8, 2023
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·February 8, 2023