MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS SUCTION PUMP MODEL KV-4

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2)

TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

Stimulator, Nerve

FDA classification

FDA Class 2 ·Stimulator, Nerve

Reservoir, Blood, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)

Over-The-Counter Powered Light Based Laser For Acne

FDA classification

FDA Class 2 ·Over-The-Counter Powered Light Based Laser For Acne

DermaSensor

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

FDA classification

FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass, Exempt

On-Body Injector

FDA classification

FDA Class 2 ·On-Body Injector

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODULAR PORP AND TORP MODEL TBD

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ORTHOLOC™ 2 Lapidus with Rotation System

FDA 510(k)

FDA Class 2 ·Orthopedic