38 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Japan
×
Dry Incubator / EC6S-230MR
Device
EU MDR
·
Eu Md Class 2a
·ASTEC CO.,Ltd·On the market·3 countries
Protex Probe Cover Dry
Device
EU MDR
·
Eu Md Class 2b
·Sagami Rubber Industries Co., Ltd.·On the market·1 country
DRI OCT Triton (plus)
Device
EU MDR
·
Eu Md Class 2a
·TOPCON CORPORATION·On the market·32 countries
Dry Shipper DR-2DSE
Device
EU MDD
·
Eu Md Class 2a
·Taiyo Nippon Sanso Corporation·On the market·1 country
DRI OCT Triton
FDA 510(k)
FDA Class 2
·Ophthalmic
3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT TRITON
Device
EU MDR
·
Eu Md Class 2a
·TOPCON CORPORATION·On the market·2 countries
DRY LASER IMAGER, DRYPRO MODEL 832
FDA 510(k)
FDA Class 2
·Radiology
DRY LASER IMAGER, MODEL DRYPRO MODEL 793
FDA 510(k)
FDA Class 2
·Radiology
Dry Incubator
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·ASTEC CO.,Ltd·1 device
Dry Shipper DR-2DSE
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Taiyo Nippon Sanso Corporation·1 device
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
FDA Enforcement
Class III
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023