32 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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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
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
FDA Enforcement
Class II
·Terminated·Canon Inc.·June 5, 2013
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016