PERMA FACIAL IMPLANTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Facial Implant

FDA classification

FDA Class 2 ·Facial Implant

TribusConnect

FDA 510(k)

FDA Class 2 ·Radiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

VERTIX 3D-U

FDA 510(k)

FDA Class 2 ·Radiology

ARTERIAL DIAGNOSTIC UNIT (ADU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MyoStrain 5.1

FDA 510(k)

FDA Class 2 ·Radiology

SpiroHome Personal, SpiroHome Clinic

FDA 510(k)

FDA Class 2 ·Anesthesiology

BD U-500 INSULIN SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

TNS MK I STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)

FDA 510(k)

FDA Class 2 ·Anesthesiology

GE DATEX-OHMEDA S/5 ADU CARESTATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology

PREMIER-CRYPTOCOCCAL ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

ALPHA CRYPTOCOCCAL ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)

FDA 510(k)

FDA Class 2 ·Anesthesiology