Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER

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

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

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

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

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

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER

FDA 510(k)

FDA Class 2 ·Orthopedic

GEM Biover Microvascular Clamps

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CoolSculpting Elite System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 545-45 LASER FOR DERMA., POD., SURGICAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MORPHINE ROCHE (R) EIA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR BENZODIAZEPINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR COCAINE/COCAINE META. TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Peri-Guard and Supple Peri-Guard

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery