18 results
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24ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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Kai Industries Co., Ltd.
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·6 Devices·4 Importers·TÜV Rheinland LGA Products GmbH
DKK DAI-ICHI SHOMEI CO, LTD
FDA registration
DKK DAI-ICHI SHOMEI CO, LTD·5 products·🇯🇵 Japan
DERMAL CURETTE 2 mm
Device
EU MDR
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Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 7 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 5 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 4 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 3 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
Tissue-Tek VIP 6 AI
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Sakura Seiki Co., Ltd.·1 device
DERMAL CURETTE
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·6 devices
HZ 2066395-1
Certificate
MDR QMS·Kai Industries Co., Ltd.·TÜV Rheinland LGA Products GmbH
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 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
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
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
FDA Enforcement
Class II
·Completed·Fukuda Denshi Co., Ltd.·December 13, 2017