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Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.

FDA Enforcement
Class II ·Terminated·Inion Ltd.·March 22, 2017

Nightingale Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Nightingale Health Oyj·2 devices

COVID-19 Real Time Multiplex RT-PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·1 device

COVID-19 Real Time Multiplex RT-PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·1 device

Respiratory Multiplex RT-PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·1 device

Respiratory Multiplex RT-PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·1 device

Biocard™ Celiac Home

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Labsystems Diagnostics Oy·1 device

Vanadis Core T21/T18/T13 Reagent Cartridge

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

Vanadis Core T21/T18/T13 Reagent Cartridge

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

Vanadis View Plate

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Wallac Oy·1 device

Vanadis Core Buffer kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Wallac Oy·1 device

Vanadis Extract Bind and Wash kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Wallac Oy·1 device

Vanadis Extract Reagent kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Wallac Oy·1 device

U/CSF Protein

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·1 device

Glucose (HK)

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EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·2 devices

Glucose (GOD-POD)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·2 devices

Amylase (IFCC)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·1 device

CK-MB

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·2 devices

CRP

Basic UDI-DI
EU IVDD · Eu Ivd General ·Thermo Fisher Scientific Oy·1 device

Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set

Basic UDI-DI
EU IVDD · Eu Ivd General ·Thermo Fisher Scientific Oy·1 device