15 results
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34ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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Limbus AI Inc.
Manufacturer
🇨🇦 Canada·Kiwa Dare B.V.
Limbus AI Inc.
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·3 Devices
INSTRUMENTS FOR RADIOTHERAPY SIMULATION - SOFTWARE ACCESSORIES
Device
EU MDR
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Eu Md Class 2b
·Limbus AI Inc.·On the market·14 countries
Limbus Contour
Device
EU MDD
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Eu Md Class 1
·Limbus AI Inc.·No longer on the market·13 countries
INSTRUMENTS FOR RADIOTHERAPY SIMULATION - SOFTWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 2b
·Limbus AI Inc.·On the market·14 countries
Limbus Contour
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Limbus AI Inc.·1 device
Limbus Contour
Basic UDI-DI
EU MDR
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Eu Md Class 2b
·Limbus AI Inc.·2 devices
21M00123CRT01
Certificate
MDR QMS·Limbus AI Inc.·Kiwa Dare B.V.
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