Tracheostomy Kit

FDA classification

FDA Class 2 ·Tracheostomy Kit

OSW Aligner System

FDA 510(k)

FDA Class 2 ·Dental

ORAGENE DX OGD-500.001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DNA/RNA Shield SafeCollect Saliva Collection kit

FDA 510(k)

FDA Class 2 ·Microbiology

DNA/RNA Shield Collection Tube

FDA 510(k)

FDA Class 2 ·Microbiology

MIVI Mi-AXUS Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2

FDA 510(k)

FDA Class 2 ·General Hospital

VersaD Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EUCLID (TM) TIER 1-GW ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Suction Irrigation Tubing Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bladeless Trocar; Bladed Trocar; Hasson Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

CONDOMS (RUBBER CONTRACEPTIVES)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1570 - FETAL BLOOD SAMPLING KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology