18 results · 21ms · Sources: EU EUDAMED, US FDA

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Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

FDA 510(k)
FDA Class 2 ·General Hospital

Aerotel Medical Systems (1998) Ltd.

Manufacturer
🇮🇱 Israel·5 Basic UDI-DIs·5 Devices·SGS FIMKO OY

ECG HOLTER RECORDERS

Device
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries

ECG HOLTER RECORDERS

Device
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries

ECG HOLTER RECORDERS

Device
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries

ECG HOLTER RECORDERS

Device
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries

ECG DATA MANAGEMENT SYSTEMS

Device
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries

TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

HRS

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·1 device

HeartView

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·1 device

HeartView

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·1 device

HeartView

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·1 device

HeartView

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerotel Medical Systems (1998) Ltd.·1 device

17/07002

Certificate
MDD Annex V·Aerotel Medical Systems (1998) Ltd.·SGS FIMKO OY·5 Basic UDI-DIs