26 results · 18ms · Sources: EU EUDAMED, US FDA

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CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM

FDA 510(k)
FDA Class 2 ·Radiology

c8100 HHT/Sysmex TrayLane Arm cover

Device
EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Medium size adult arm cuff (HEM-CR19)

Device
EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·14 countries

Large size adult arm cuff (HEM-CL19)

Device
EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·14 countries

Small size adult arm cuff (HEM-CS19)

Device
EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·13 countries

Small size adult arm cuff

Basic UDI-DI
EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·1 device

Medium size adult arm cuff

Basic UDI-DI
EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·1 device

Large size adult arm cuff

Basic UDI-DI
EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·1 device

c8100 HHT/Sysmex TrayLane Arm cover

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·1 device

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

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device