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