ActiveCare Home

FDA 510(k)

FDA Class 2 ·Cardiovascular

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hominis Surgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CardioGard Emboli Protection Cannula

FDA 510(k)

FDA Class 2 ·Cardiovascular

Anovo Surgical System (model 6N)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

System, Imaging, Optical Coherence Tomography (Oct)

FDA classification

FDA Class 2 ·System, Imaging, Optical Coherence Tomography (Oct)

Light Source, Photographic, Fiberoptic

FDA classification

FDA Class 2 ·Light Source, Photographic, Fiberoptic

Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

FDA classification

FDA Class 2 ·Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Medline ReNewal Reprocessed Stryker SERF AS Energy Probes

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEAD TERMINAL PIN CAPS, VARIOUS MODELS

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROPAQ MONITORS, MODIFICATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACUMED SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 210 IMPEDANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PELVX INCONTINENCE DISH, MODEL 301-306

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology