3,416 results · 44ms · Sources: EU EUDAMED, US FDA

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ARCHITECT

FDA UDI
ABBOTT LABORATORIES·00380740019655·Acid Phosphatase

CLC GAMMA-GLUTAMYL TRANSFERASE GGT REAGENT KIT AU-209

FDA UDI
CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302024050·Gamma Glutamyl Transferase

ACP

FDA UDI
RANDOX LABORATORIES LIMITED·05055273200065·The acid phosphatase test system is intended fo...

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEPTEST

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM

DAB Away Kit

Device
EU IVDR · Eu Ivd Class A ·Lumatas BioSystems Inc·On the market

Trusculpt 3D

FDA registration
MEDAVITRO FZCO LLC·2 products·🇦🇪 United Arab Emirates

BTL 799-2L

FDA registration
MEDAVITRO FZCO LLC·1 product·🇦🇪 United Arab Emirates

Affiniti 30 Diagnostic Ultrasound System

FDA registration
MEDAVITRO FZCO LLC·3 products·🇦🇪 United Arab Emirates

GMV Plexr Plus

FDA registration
MEDAVITRO FZCO LLC·1 product·🇦🇪 United Arab Emirates

GE Voluson E8 Transducer

FDA registration
MEDAVITRO FZCO LLC·3 products·🇦🇪 United Arab Emirates

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ACTROS DR+ -B PULSE GENERATOR

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

TOILET STOOLS

Device
EU MDR · Eu Md Class 1 ·Zhongshan Kangdebao(KDB) Rehabilitation Equipment Co.,Ltd.·On the market·32 countries

SCANLISA HUMAN CRP ELISA KIT

FDA 510(k)
FDA Class 2 ·Immunology

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY