APR POROUS HA HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·COMFORTCARE GP(R) WETTING AND SOAKING SOLUTION

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PCM 2000; ISOLAIR APR MODEL 2735

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APR II NON POROUS HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INTERMEDICS APR(TM) II FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APR II NON-POROUS HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

GERSON ISOLAIR APR PARTICULATE SURGICAL MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OTOFLEX 100 TYE 1012

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BIOLIGHT BIODYNAM

FDA 510(k)

FDA Class 2 ·Physical Medicine

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRESCO TI IMPLANT CONCEPT

FDA 510(k)

FDA Class 2 ·Dental

SPEECHLINK 100 TYPE 1053

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 3 BONE CEMENT

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wireless Smart Gluco-Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LANTOR CUBE STERILIZER TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery