Disposable Surgical Mask/Fluid Resistant Procedure Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIAB SPA, MODELS F7244, F7233, F7234, F7277

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Digistat Smart Central

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Cliniview

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)

FDA 510(k)

FDA Class 2 ·Orthopedic

E-EEGX, N-EEGX

FDA 510(k)

FDA Class 2 ·Neurology

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIVASCREW

FDA 510(k)

FDA Class 2 ·Orthopedic