31 results · 34ms · Sources: EU EUDAMED, US FDA

GOODALL LASER TARGETING DEVICE

FDA 510(k)
FDA Class 2 ·Radiology

GAMMA3 AND T2 RECON TARGETING DEVICES

FDA 510(k)
FDA Class 2 ·Orthopedic

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·LITHOTRON ULS

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST

ID NOW COVID-19 2.0

FDA 510(k)
FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)
FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)
FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)
FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CUTTING BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CUTTING BALLOON MONORAIL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CUTTING BALLOON

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CUTTING BALLOON ULTRA

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0