2,683 results · 23ms · Sources: EU EUDAMED, US FDA

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV HR COMPONENTS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Cobas TaqMan HBV Test v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

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 ·Cobas HPV Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas HBV

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·THERMACHOICE UTERINE BALLOON THERAPY SYSTEM

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·AMS UROLUME ENDOPROSTHESIS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restlyane® Refyne Injectable Gel

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·ENLITE GLUCOSE SENSORS

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD