WERAY

FDA 510(k)

FDA Class 2 ·Dental

WeSensor

FDA 510(k)

FDA Class 2 ·Dental

Will3D

FDA 510(k)

FDA Class 2 ·Radiology

Retraction, CWM-910T, APOLEX Tite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FilmArray Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Tropical Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS

FDA 510(k)

FDA Class 2 ·Hematology

SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER

FDA 510(k)

FDA Class 2 ·Orthopedic

GEM Biover Microvascular Clamps

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CoolSculpting Elite System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 545-45 LASER FOR DERMA., POD., SURGICAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MORPHINE ROCHE (R) EIA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR BENZODIAZEPINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology