17 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Japan
×
ZACROS CORPORATION MIE FACILITY
FDA registration
ZACROS CORPORATION MIE FACILITY·1 product·🇯🇵 Japan
FUJIFILM Healthcare Manufacturing Corporation MIE Office
FDA registration
FUJIFILM Healthcare Manufacturing Corporation MIE Office·12 products·🇯🇵 Japan
Shimadzu, Trinias, Digital Angiography System
FDA Enforcement
Class II
·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·March 20, 2024
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Hitachi Ltd., Medical System Operations Group·May 9, 2018
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·March 30, 2016
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·August 28, 2024
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
FDA Enforcement
Class II
·Ongoing·Shimadzu Corp. Analytical & Measuring Instruments Div.·December 4, 2024
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
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
FDA Enforcement
Class II
·Terminated·Dentech Corp.·June 2, 2021
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.
FDA Enforcement
Class II
·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·November 19, 2025