64 results · 29ms · Sources: EU EUDAMED, US FDA

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Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360® Liquid CDx

SpheRx

FDA UDI
Nuvasive, Inc.·00887517332738·Fixed Screw Driver

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046752067·Rotary diamond instrument for dental application

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046757758·Rotary diamond instrument for dental application

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046760731·Rotary diamond instrument for dental application

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·47291046754830·Rotary diamond instrument for dental application

SPACELABS HEALTHCARE

FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522122668·10 ELECTRODE PT.CABLE, SHORT.BA

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506082559·REUSABLE LIGHTWEIGHT IRRIGATION/SUCTION SYSTEM ...

Powered Mobility Scooter

FDA 510(k)
FDA Class 2 ·Physical Medicine

CERTAIN GOLD-TITE TM HEXED SCREW

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·April 3, 2025

Apex Lifts

FDA UDI
JOERNS HEALTHCARE, LLC·00810055881130·C-HLA-2 W/MESH SM U-SLING W/ HD SUPPORT

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 28-8 pharmDx

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ D-Light C PDD System

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ Photodynamic Diagnostic (PDD) D-Light System

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC NIVOLUMAB PHARMDX

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ Photodynamic D-Light C PDD System

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM