BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B

FDA 510(k)

FDA Class 2 ·Orthopedic

Bio-Medicus Life Support Catheter and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

Cystoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Oral Matrix

FDA 510(k)

FDA Class 2 ·Dental

Disposable Laparoscope Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Specimen Retrieval Bag

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medical Surgical Gowns

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM

NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental