1,748 results · 18ms · Sources: EU EUDAMED, US FDA

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·DARDIK BIOGRAFT FOR USE IN PERIPHERAL VASCULAR SUR

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C® Cervical Disc Prosthesis (one-level use)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3033C FUCTION PACT USE W/MODEL 3000 PROGRAMM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·OneStep Pacing Cable Assembly used wit R Series Device

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C® Cervical Disc Prosthesis (two-level use)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·POSSIS ANGIOJET(R) RHEOLYTIC(TM) THROMBECTOMY SYSTEM - CORONARY USE

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADAR VISION TREATMENTS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MULTIPLE APPLICATION UTILITY (MAU) USED WITH ZOOM LATITIDE PROGRAMMING SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TaqMan HBV Test, For Use With High Pure System

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·prodisc - C and prodisc - C Nova (Indicated for Single Level Use)

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE