Safety Blood Collection Device for Single Use

FDA 510(k)

FDA Class 2 ·General Hospital

Pearl Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use

FDA 510(k)

FDA Class 2 ·General Hospital

NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')

FDA 510(k)

FDA Class 2 ·General Hospital

CushionCast Moldable Cushions

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Laparoscopic Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Osteo-site Vertebral Balloon

FDA 510(k)

FDA Class 2 ·Orthopedic

Sterile Syringe with Fixed Safety Needle for Single Use

FDA 510(k)

FDA Class 2 ·General Hospital

Bone Marrow Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Navigated Pedicle Access Kit

FDA 510(k)

FDA Class 2 ·Neurology

INTEGRA ELECTRODE TUNNELING NEEDLE

FDA 510(k)

FDA Class 2 ·Neurology

EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

FDA 510(k)

FDA Class 2 ·General Hospital

V-Patch Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Implantswiss Dental Implant System and Implantswiss Dental Abutment System

FDA 510(k)

FDA Class 2 ·Dental

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ENZYMUN TEST{R} CEA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA KIT