5,924 results · 148ms · Sources: EU EUDAMED, US FDA

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T-Handle Assy, Quick Connect, Hex, 1/2" (Shukla Nail S9NAIL, Shukla Broken Nail S9NAIL-BR, Shukla Lag Screw S9LAG Extraction Systems)

Device
EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Wrench, Double Open End, 1/2" & 11/16" (Shukla Knee S9KNEE, Shukla Nail S9NAIL, Shukla Anterior Hip S9HIP-ANT Extraction Systems)

Device
EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval
FDA Class 3 ·BAYER IMMUNO 1 COMPLEXED PSA ASSAY

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval
FDA Class 3 ·BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·Exablate 2100/2100 VI System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System

EPIQ 7 Diagnostic Ultrasound System; L12-3; L12-4; L12-5 50; L15-7io; L18-5; S12-4; S4-2; S5-1; S7-3t; S8-3; V6-2;

FDA registration
Modality Group Ltd·3 products·🇬🇧 United Kingdom

Emergo Europe B.V.

Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices

Made-To-Order

FDA UDI
TORNIER, INC.·00846832097722·2-In-1 Drill/Reamer

Made-To-Order

FDA UDI
TORNIER, INC.·00846832097708·2-In-1 Drill/Reamer

Made-To-Order

FDA UDI
TORNIER, INC.·00846832097715·2-In-1 Drill/Reamer

BREG

FDA UDI
BREG, INC.·00672736020678·

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Minerva Endometrial Ablation System

Immunohistochemistry Antibody Assay, C-Kit

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval
FDA Class 3 ·Edwards EVOQUE Tricuspid Valve Replacement System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT