60 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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MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·November 2, 2022
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 4, 2026
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 1, 2023
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
FDA Enforcement
Class II
·Ongoing·3M Company - Health Care Business·October 16, 2024
GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022