Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS

HR - HOSPITALAR, LDA

Importer

🇵🇹 Portugal·1 Manufacturer

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY

Dental Implant Ø 3.2mm Length:8mm PLATFORM: 3.0mm

Basic UDI-DI

EU MDD · Eu Md Class 2b ·RH POZİTİF TIBBİ CİHAZLARI İMALAT TEKNOLOJİ ANONİM ŞİRKETİ·1 device

Arazy Group (Ireland) Ltd.

Authorized representative

🇮🇪 Ireland·17 Manufacturers·425 Devices

H. + H. Maslanka Chirurgische Instrumente GmbH

Importer

🇩🇪 Germany

1984-MDD-18-480

Certificate

MDD Annex II (excluding section 4)·RH POZİTİF TIBBİ CİHAZLARI İMALAT TEKNOLOJİ ANONİM ŞİRKETİ·Kiwa Belgelendirme Hizmetleri A.Ş.·1 Basic UDI-DI

Television, Less Than 25kv And Less Than 0.1 Mr/Hr

FDA classification

FDA Not Classified ·Television, Less Than 25kv And Less Than 0.1 Mr/Hr

H. + H. Maslanka Chirurgische Instrumente GmbH

Authorized representative

🇩🇪 Germany

Biosafety Cabinet SMI-163ANMD2

FDA registration

S.M. SCIENTIFIC INSTRUMENTS PVT. LTD. Jindal manufacturing facility·1 product·🇮🇳 India

mdi Europa GmbH

Authorized representative

🇩🇪 Germany·132 Manufacturers·4741 Devices

Affiniti Humeral Instrument kit

FDA registration

SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD·1 product·🇬🇧 United Kingdom

Affiniti Humeral Instrument kit

FDA registration

SYMMETRY MEDICAL MANUFACTURING INC·1 product·🇺🇸 United States

Affiniti Humeral Instrument kit

FDA registration

SYMMETRY MEDICAL MANUFACTURING INC.·1 product·🇺🇸 United States

Affiniti Humeral Instrument kit

FDA registration

SYMMETRY MEDICAL MANUFACTURING INC·1 product·🇺🇸 United States

Kingsmead Service B.V.

Authorized representative

🇳🇱 Netherlands·243 Manufacturers·2698 Devices

Platinum

FDA UDI

SUMMUS MEDICAL LASER, LLC·B679SLP4H0·Light weight (~2.5 Kg.) and portable therapeuti...