One-Step Suprapubic Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Safety Wire Guide Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cook 810 Set, Desilets-Hoffman Introducer Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Kosmos

FDA 510(k)

FDA Class 2 ·Radiology

RELIANT LASER II SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RIGEL™ 3DR Anterior Cervical Corpectomy System

FDA 510(k)

FDA Class 2 ·Orthopedic

RIGEL 3DR Anterior Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACON ONE STEP PREGNANCY TEST STRIP (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACON ONE STEP HOME PREGNANCY TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPEX REHAB

FDA 510(k)

FDA Class 2 ·Physical Medicine

TOTAL KNEE CEMENTED, SEMI-CONSTRAINED

FDA 510(k)

FDA Class 2 ·Orthopedic

N20 TEST

FDA 510(k)

FDA Class 2 ·Anesthesiology

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology