Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AI Platform 2.0 (AIP002)

FDA 510(k)

FDA Class 2 ·Radiology

Strain AI (SAI001)

FDA 510(k)

FDA Class 2 ·Radiology

MH1 MICROHOLTER RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOCLAV VENOUS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bladder AI (AIBV01)

FDA 510(k)

FDA Class 2 ·Radiology

AI Platform (AIP001)

FDA 510(k)

FDA Class 2 ·Radiology

Lung AI (LAI001)

FDA 510(k)

FDA Class 2 ·Radiology

AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KALIX II IMPLANT, MODEL 141 0XX WITH XX

FDA 510(k)

FDA Class 2 ·Orthopedic

Exo Iris

FDA 510(k)

FDA Class 2 ·Radiology

Exo Iris (El2001)

FDA 510(k)

FDA Class 2 ·Radiology

CLINICAL HANDMASTER SYSTEM OR CHMS

FDA 510(k)

FDA Class 2 ·Orthopedic

SIGMA 7000 AND SIGMA70002

FDA 510(k)

FDA Class 2 ·General Hospital

SIGMA 8000 AND SIGMA 8002

FDA 510(k)

FDA Class 2 ·General Hospital

SIGMA 8000 AND SIGMA 8002

FDA 510(k)

FDA Class 2 ·General Hospital

STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX

FDA 510(k)

FDA Class 2 ·Orthopedic

BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX

FDA 510(k)

FDA Class 2 ·Cardiovascular

OsteoReady Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental