10,000 results · 115ms · Sources: EU EUDAMED, US FDA

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Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collaslat Absorbable Collagen Hemostatic - Microfibrillar Form

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

FDA Pre-Market Approval
BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Dimension TPSA Flex Reagent Cartridge

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·MENTOR SALINE FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring Systems

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve Evolut R System and CoreValve Evolut PRO System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX Reflux Management System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella Ventricular Support Systems

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·Dimension FPSA Flex Reagent Cartidge

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ACUITY STEERABLE LEAD SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SENOGRAPHE DS & 2000D FFDM SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·VALITUDE CRT-P

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

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0