29 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Achieva XR. Model (REF) Numbers 781153, 781253.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·March 9, 2016
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014