23 results · 54ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MeMed Diagnostics Ltd.

Manufacturer
🇮🇱 Israel·4 Basic UDI-DIs·4 Devices·1 Importer

Savyon Diagnostics Ltd.

Manufacturer
🇮🇱 Israel·1 Importer

MYOR Diagnostics Ltd.

Manufacturer
🇮🇱 Israel

S.D. Sight Diagnostics Ltd

Manufacturer
🇮🇱 Israel·2 Basic UDI-DIs·2 Devices

Lev-EL Heart Diagnostics Ltd.

Manufacturer
🇮🇱 Israel

SAVYON DIAGNOSTICS LTD.

FDA registration
SAVYON DIAGNOSTICS LTD.·13 products·🇮🇱 Israel

MeMed Diagnostics Ltd

FDA registration
MeMed Diagnostics Ltd·2 products·🇮🇱 Israel

MeMed BV® External Control

Device
EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·On the market·4 countries

MeMed BV® Calibrator

Device
EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·On the market·4 countries

MeMed BV®

Device
EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·On the market·4 countries

MeMed Key®

Device
EU IVDR · Eu Ivd Class A ·MeMed Diagnostics Ltd.·On the market·0 countries

Sight OLO

Device
EU IVDD · Eu Ivd General ·S.D. Sight Diagnostics Ltd·No longer on the market

Sight OLO CBC Test Kit

Device
EU IVDD · Eu Ivd General ·S.D. Sight Diagnostics Ltd·No longer on the market

MeMed BV® External Control

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·1 device

MeMed BV® Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·1 device

MeMed BV®

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·1 device

MeMed Key®

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·MeMed Diagnostics Ltd.·1 device

Sight OLO

Basic UDI-DI
EU IVDD · Eu Ivd General ·S.D. Sight Diagnostics Ltd·1 device

Sight OLO CBC Test Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·S.D. Sight Diagnostics Ltd·1 device

Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

FDA Enforcement
Class II ·Ongoing·SIGHT DIAGNOSTICS LTD·July 3, 2024