Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Automated External Defibrillator (AED) Systems

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Automated External Defibrillator (AED) Systems

HG Innovations Ltd

Manufacturer

Grace Medical, Inc.

Manufacturer

🇺🇸 United States·1 Importer

C2Dx Inc.

Manufacturer

🇺🇸 United States

MYSORE WIFILTRONICS PRIVATE LIMITED

Manufacturer

🇮🇳 India

Intact Vascular, Inc.

Manufacturer

🇺🇸 United States·8 Basic UDI-DIs·8 Devices·BSI Group The Netherlands B.V.

OrbusNeich Medical (Shenzhen) Co.,Ltd

Manufacturer

🇨🇳 China·1058 Basic UDI-DIs·1058 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Baylis Medical Company Inc.

Manufacturer

🇨🇦 Canada·1 Importer

Puretone Ltd.

Manufacturer

LumaDent Inc

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·3 Devices

Delta Surgical Limited

Manufacturer

GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)

FDA 510(k)

FDA Class 2 ·Anesthesiology

GE DATEX-OHMEDA S/5 ADU CARESTATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTACLE FRAMES WITHOUT LENSES - OTHER

Device

EU MDR · Eu Md Class 1 ·WENZHOU ODO OPTICAL CO.,LTD·On the market·32 countries

ZELLESR-20

FDA registration

STERILE SAFEQUIP & CHEMICALS LLP·1 product·🇮🇳 India

ZELLECHEM-SR

FDA registration

STERILE SAFEQUIP & CHEMICALS LLP·1 product·🇮🇳 India

ZBT-ESR

FDA registration

STERILE SAFEQUIP & CHEMICALS LLP·1 product·🇮🇳 India

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology