ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CliniCloud Stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Endoscopic Hemoclip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TUBE GASTROSTOMY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AXXENT SURFACE APPLICATOR, MODEL 710257

FDA 510(k)

FDA Class 2 ·Radiology

SURGITRON RADIOLASE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Unscented Menstrual Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WiZARD 310/320 Series CPAP Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

FIA Blood Glucose Monitoring System (G2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SURGITRON IEC II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HIVOX OTC Electrical Stimulator

FDA 510(k)

FDA Class 2 ·Neurology

LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATION NM DIAGNOSTIC CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electrosurgical Pads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGITRON MODEL FFPF-EMC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC

FDA 510(k)

FDA Class 2 ·Radiology

AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology