1400 SERIES EVIDENCE COLLECTION KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Immunology

Globalcare Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

GCE704 Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIGHT SABER SPINAL NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

CYBERCASES BY BAUSCH & LOMB

FDA 510(k)

FDA Class 2 ·Ophthalmic

RENU MULTIPLUS LUBRICATING & REWETTING DROPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Xpine Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARMA-RS, KARMA-FS WHEELCHAIRS

FDA 510(k)

FDA Class 2 ·Physical Medicine

CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148

FDA 510(k)

FDA Class 2 ·Cardiovascular

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray

FDA 510(k)

FDA Class 2 ·General Hospital

VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK

FDA 510(k)

FDA Class 2 ·Orthopedic

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)

FDA 510(k)

FDA Class 2 ·Dental