19 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·June 24, 2026
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
FDA Enforcement
Class II
·Terminated·AMD Medicom Inc.·November 27, 2019
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
FDA Enforcement
Class II
·Terminated·AMD Medicom Inc.·November 27, 2019
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·February 28, 2024
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·February 28, 2024
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·February 28, 2024
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·June 24, 2026
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·April 29, 2026
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·April 29, 2026
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·December 3, 2025
FoundationOne Companion Diagnostic (F1CDx)
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·June 11, 2025
FoundationOne Companion Diagnostic (F1CDx)
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·June 11, 2025
FoundationOne Companion Diagnostic (F1CDx)
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·May 21, 2025
FoundationOne CDx test report
FDA Enforcement
Class II
·Terminated·Foundation Medicine, Inc.·December 4, 2019
FoundationOne CDx Test Results
FDA Enforcement
Class II
·Terminated·Foundation Medicine, Inc.·December 26, 2018
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·December 3, 2025
Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
FDA Enforcement
Class II
·Terminated·Mueller Sports Medicine, Inc·July 8, 2020
Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 23, 2014
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 23, 2014