4,631 results · 27ms · Sources: EU EUDAMED, US FDA

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·USCI GRUNTZIG DILACA CORNARY BALLOON DILATATION CA

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED QUANTUM(TM) PTCA CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·CHARTER LABS SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ENZYMUN-TEST{R} AFP

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·LEOCOR SABLE(TM) PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED ACE(TM) & EXPRESS(TM) PTCA CATHETERS

Suture, Absorbable

FDA Pre-Market Approval
FDA Class 2 ·COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·HELIX PTCA DILATATION CATHETER

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·TECHNOMED INTERNATIONAL SONOLITH 2000

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·APPLIED LABORATORIES STERILE SALINE SOLUTION

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SOFTHERM SOL.