Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MODELS MPL9000 MODIFICATIONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·3.4F SYNERGY(TM) II LONG BALL. DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) ACE(TM) 1CM TIP PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER MC RAIL(TM) 20,30,40 SLIDING RAIL PTCA

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SORBIC ACID PRESERVED SALINE SOL.PH CHANGE

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ULTRAZYME PROTEIN CLEANER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN RAPID FLUOROGENIC PANELS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CONTACLAIR MULTI-PURPOSE SOLUTION

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·NOVALENS (ROSILFOCON A)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS OTW SOLARIS CORONARY DILATATION CATHETER

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(TM)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PRIME{TM} MODEL 6520, 6525, 6530 AND 6535

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON EQUALENS(R) AND BOSTON RXD(R)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENSRINS(R) STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTLENS CLEANING & DISINFECTING SOLN.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS CORONARY DILATATION CATHETERS