35 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. Ina Laboratory
FDA registration
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. Ina Laboratory·1 product·🇯🇵 Japan
EVIS EXERA III Bronchovideoscope
FDA Enforcement
Class II
·Terminated·Aizu Olympus Co., Ltd.·August 31, 2022
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
FDA Enforcement
Class II
·Ongoing·Shimadzu Corp. Analytical & Measuring Instruments Div.·December 4, 2024
Nakanishi Inc.
System producer
🇯🇵 Japan
DZ 2081569-1
Certificate
MDR QA·CYBERDYNE Inc.·TÜV Rheinland LGA Products GmbH
HZ 2100551-1
Certificate
MDR QMS·MANI, INC.·TÜV Rheinland LGA Products GmbH
HD 2029991-1
Certificate
MDD Annex II (excluding section 4)·Ziosoft, Inc.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
HZ 2003379-1
Certificate
MDR QMS·Konica Minolta, Inc.·TÜV Rheinland LGA Products GmbH
V1 027591 0045
Certificate
IVDD Annex IV (excluding sections 4, 6)·ARKRAY Factory, Inc.·TÜV SÜD Product Service GmbH·141 Basic UDI-DIs
JP19/040495
Certificate
MDD Annex II (excluding section 4)·Tokai Medical Products, Inc.·SGS Belgium NV·69 Basic UDI-DIs
HD 2014410-1
Certificate
MDD Annex II (excluding section 4)·AIR WATER REALIZE INC.·TÜV Rheinland LGA Products GmbH·55 Basic UDI-DIs
G1 016328 0144
Certificate
MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
JP20/819943399
Certificate
MDD Annex II Section 4·Tokai Medical Products, Inc.·SGS Belgium NV·1 Basic UDI-DI
G1 016328 0144
Certificate
MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·401 Basic UDI-DIs
G1 016328 0145
Certificate
MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs
JP19/040507
Certificate
MDD Annex II (excluding section 4)·PIOLAX MEDICAL DEVICES, INC.·SGS Belgium NV·22 Basic UDI-DIs
HZ 2094592-1
Certificate
MDR QMS·Kuraray Noritake Dental Inc. Kurashiki·TÜV Rheinland LGA Products GmbH
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
FDA Enforcement
Class I
·Ongoing·WHILL, INC.·May 6, 2026
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
FDA Enforcement
Class I
·Ongoing·WHILL, INC.·May 6, 2026
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
FDA Enforcement
Class II
·Terminated·Canon Inc.·September 5, 2012