10,000 results · 106ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER AND PFO OCCLUDER AMPLATZER 45 DEGREE DELIVERY AND EXANGE SYSTEMS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

Ivory Glove Powder-Free Nitrile Examination Gloves

FDA 510(k)
FDA Class 1 ·General Hospital

Surgical Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Medical nitrile examination gloves (Model: SH001)

FDA 510(k)
FDA Class 1 ·General Hospital

Surgical Face Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Paneffort 3-ply Surgical and Procedural Masks

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Biofeedback Nerve and Muscle Stimulator

FDA 510(k)
FDA Class 2 ·Physical Medicine

Hipro Glycosylated Hemoglobin (HbA1c) Test System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Afinion HbA1c Dx on Afinion 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

FDA 510(k)
FDA Class 2 ·Hematology

Afinion HbA1c Dx

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Alere Afinion HbA1c, Alere Afinion AS100 Analyzer

FDA 510(k)
FDA Class 2 ·Hematology

EFAI ChestSuite XR Pleural Effusion Assessment System

FDA 510(k)
FDA Class 2 ·Radiology

SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60,

AF811

FDA UDI
Respironics, Inc.·00606959042407·Philips Procedure, AF811 with Filtered Exhalati...

PerformaTrak

FDA UDI
Respironics, Inc.·00606959042506·Philips Procedure, CapStrap with Filtered Exhal...