Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Pre-Market Approval

FDA Class 2 ·MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS TX2000 VP CORONARY DILITATION CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAXXUM PTCA CATHETER

Cranial Surgical Planning And Instrument Guides

FDA classification

FDA Class 2 ·Cranial Surgical Planning And Instrument Guides

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK (TM)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage

Additively Manufactured, Preformed, Resin Denture Tooth

FDA classification

FDA Class 2 ·Additively Manufactured, Preformed, Resin Denture Tooth

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE