2,258 results · 21ms · Sources: EU EUDAMED, US FDA

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Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Intera 3000 Hepatic Artery Infusion Pump

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·THINPREP(R) PROCESSOR, MODEL TP 2000

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBC TOTAL ASSAY

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx (F1CDx)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC-ONE (HYLAN G-F 20)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC and SYNVISC ONE