DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

FDA 510(k)

FDA Class 2 ·Dental

LUER LOCK TRANSFER PIN

FDA 510(k)

FDA Class 2 ·General Hospital

SURG/ASSIST MODEL SA-1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHARMULATOR

FDA 510(k)

FDA Class 2 ·General Hospital

LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TANDEM SETS I.V.

FDA 510(k)

FDA Class 2 ·General Hospital

PHARM-ASSIST

FDA 510(k)

FDA Class 2 ·General Hospital

SYRINGE TIP ADAPTOR

FDA 510(k)

FDA Class 2 ·General Hospital

INTOPO

FDA 510(k)

FDA Class 2 ·General Hospital

E-Z GOLD TOOTH FILLING MATERIAL

FDA 510(k)

FDA Class 2 ·Dental