AMBULASE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMCOM COMMTECH MESSENGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYRINGE DISPOSAL SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

SPINNAKER

FDA 510(k)

FDA Class 2 ·Anesthesiology

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMEX FUTURALDOP PRO

FDA 510(k)

FDA Class 2 ·Radiology

VASCUCLEAR PRECISION BIPOLAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TriSalus Infusion System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BATTERY PACKS (VARIOUS MODELS)

FDA 510(k)

FDA Class 2 ·Radiology

SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MIC ANTIBIOTIC TEST PANELS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MIC ANTIBIOTIC TEST PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MIC ANTIBIOTIC TEST PANELS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MIC ANTIBIOTIC TEST PANELS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OPTECH FRE-FLEX SOFT CONTACT LENS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PARASCRIPT ACCUDETECT 6.1.0

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PARASCRIPT (R) ACCUDETECT (R)