10,000 results · 109ms · Sources: EU EUDAMED, US FDA

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ECHO BLASTER

FDA 510(k)
FDA Class 2 ·Radiology

SmartUs EXT-1M/3M

FDA 510(k)
FDA Class 2 ·Radiology

ArtUs

FDA 510(k)
FDA Class 2 ·Radiology

SEP-10S PLUS, AND SP-12S PRO.

FDA 510(k)
FDA Class 2 ·General Hospital

XQ-1 INCUBATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

LOGICSCAN 64 LOGICSCAN 128

FDA 510(k)
FDA Class 2 ·Radiology

MicrUs

FDA 510(k)
FDA Class 2 ·Radiology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VIRTUOSO DR, VIRTUOSO VR, SECURA DR AND MAXIMO II DR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON SENOFILCON A CONTACT LENSES FOR EXTENDED WEAR

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC REMOTE HOME MONITOR

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MAGIC WALLSTENT(R) ENDOPROSTHESIS WITH DELIVERY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity Sphere and Biofinity XR Sphere, Biofinity Energys, Biofinity Toric and Biofinity XR Toric, Biofinity Multifoca

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity XR Sphere, Biofinity Energys Asphere, Biofinity Toric and Biofinity XR Torie and Biofinity Multifocal (comfilc

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS