10,000 results · 104ms · Sources: EU EUDAMED, US FDA

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL

Xesso

FDA UDI
GLOBAL PROTECTION CORP.·00850030994431·Xesso Ultra Thin 3 Pack- A latex lubricated condom

ONE Ultra Feel USA 10-Pack

FDA UDI
GLOBAL PROTECTION CORP.·00726893112667·10 Lubricated Latex Condoms

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·TEMPO PULSE GENERATORS

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·MONOVISC

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·ORTHOVISC

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Cerene Cryotherapy Device

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·HOUSECALL PLUS SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA TREMOR CONTROL THERAPY SYSTEM

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS

Temporary Non-Roller Type Left Heart Support Blood Pump

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

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Onclarity HPV Assay

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO