BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINQ II Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FlexCath Advance Steerable Sheath and Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bio-Medicus Life Support Catheter and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIT ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROASIA, MODEL L4501

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYNTEC DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL

FDA 510(k)

FDA Class 2 ·Neurology

PROASIA, MODEL L3402

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYNTEC ORTHODONTIC MINI SCREW

FDA 510(k)

FDA Class 2 ·Dental

SYNTEC OSTEO-PLATE AND SCREW FIXATION

FDA 510(k)

FDA Class 2 ·Orthopedic

Diode Laser Hair Removal System (SH-VD910)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

c1Trac

FDA 510(k)

FDA Class 2 ·Physical Medicine

MFG-05

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology