Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS

FDA 510(k)

FDA Class 2 ·Neurology

NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

FDA 510(k)

FDA Class 2 ·Anesthesiology

PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy

FDA 510(k)

FDA Class 2 ·Dental

Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·PRONOVA ABSORABLE SUTURE, USP

JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS

FDA 510(k)

FDA Class 2 ·Cardiovascular

NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE

FDA 510(k)

FDA Class 2 ·General Hospital

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System

FDA 510(k)

FDA Class 2 ·Cardiovascular