oCare Wrist Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Light Therapy System (M500, L6)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EpiFaith CV

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

PVC Hydrophilic Urethral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

InferRead Lung CT.AI

FDA 510(k)

FDA Class 2 ·Radiology

SoftFix Balloon Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medical Surgical Mask (Model: JM92, JM92B)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AmCAD-UO

FDA 510(k)

FDA Class 2 ·Radiology

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Medical Video Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cystoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Wrist - Type Fully Automatic Digital Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Afinion HbA1c Dx on Afinion 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Afinion HbA1c Dx

FDA 510(k)

FDA Class 2 ·Clinical Chemistry