1,514 results · 42ms · Sources: EU EUDAMED, US FDA

WEAR SAFE (MALAYSIA) SDN BHD

FDA registration
WEAR SAFE (MALAYSIA) SDN BHD·1 product·🇲🇾 Malaysia

CELLSTOR POT - 20ml i 40ml baegar - (10% NBF) (HOUNISENS)

Device
EU IVDR · Eu Ivd Class A ·CellPath Ltd·On the market

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi

SPIFE IFE Pentavalent Kits

FDA registration
HELENA LABORATORIES, CORP.·3 products·🇺🇸 United States

OrthoSolutions 'System26' Bone Screws

FDA 510(k)
FDA Class 2 ·Orthopedic

Ortho Solutions Plating System

FDA 510(k)
FDA Class 2 ·Orthopedic

COGNiTiON™ Staple System

FDA 510(k)
FDA Class 2 ·Orthopedic

Volition Plating System

FDA 510(k)
FDA Class 2 ·Orthopedic

SPIFE IFE-6

FDA 510(k)
FDA Class 2 ·Immunology

N-ASSAY TIA IGG

FDA 510(k)
FDA Class 2 ·Immunology

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT

FDA 510(k)
FDA Class 2 ·Immunology

HYDRASHIFT 2/4 isatuximab

FDA 510(k)
FDA Class 2 ·Immunology

IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC

FDA 510(k)
FDA Class 2 ·Immunology

CAPILLARYS IMMUNOTYPING, MODEL 2100

FDA 510(k)
FDA Class 2 ·Immunology

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389

FDA 510(k)
FDA Class 2 ·Immunology

CAPI 3 Immunotyping, Capillarys 3 Tera

FDA 510(k)
FDA Class 2 ·Immunology

MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING

FDA 510(k)
FDA Class 2 ·Immunology

PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100

FDA 510(k)
FDA Class 2 ·Immunology

IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC

FDA 510(k)
FDA Class 2 ·Immunology

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL

FDA 510(k)
FDA Class 2 ·Immunology