Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER, IMAGE CHECKER LICENSE

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·POLYVIOLENE SUTURE

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·ETHIBOND*

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Aptima HCV Quant Dx Assay

Dna-Probe, B And T Lymphocyte

FDA Pre-Market Approval

FDA Class 2 ·ONCOR B/T GENE REARRANGEMENT TEST

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

FDA Pre-Market Approval

FDA Class 2 ·BIAS(R) FIBER METAL TOTAL HIP SYSTEM

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS SUTURE (DYED)

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 3 BONE CEMENT

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS SUTURE (DYED)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM RGP CONTACT LENSES

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·DIASONICS NMR IMAGING SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 3 BONE CEMENT

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·GUT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·ABSORBABLE SURGICAL SUTURE, USP

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL (POLYGLACTIN 910) SUTURE

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)