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

FITBONE® Transport and Lengthening System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

NEWTOM 5G / NEWTOM 5G VERSION FP

FDA 510(k)

FDA Class 2 ·Radiology

CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

FDA classification

FDA Class 2 ·Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

Device, Anastomotic, Microvascular

FDA classification

FDA Class 2 ·Device, Anastomotic, Microvascular

Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CUSHIONS, DENTURE ADHESIVE, ALL-DAY

FDA 510(k)

FDA Class 2 ·Dental

DENTURE-TIGHT

FDA 510(k)

FDA Class 2 ·Dental

First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

FDA 510(k)

FDA Class 2 ·Clinical Toxicology