Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·GENESTONE 190 LITHOTRIPTER

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small

FDA 510(k)

FDA Class 2 ·Anesthesiology

Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010

FDA 510(k)

FDA Class 2 ·Dental

NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340

FDA 510(k)

FDA Class 2 ·Cardiovascular

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING

FDA 510(k)

FDA Class 2 ·Dental

ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)

FDA 510(k)

FDA Class 2 ·Dental

NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S

FDA 510(k)

FDA Class 2 ·Orthopedic

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye

FDA 510(k)

FDA Class 2 ·Anesthesiology

A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

FDA 510(k)

FDA Class 2 ·Cardiovascular