MITEK CONE WASHER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CODMAN NEUROLASE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)

FDA 510(k)

FDA Class 2 ·Anesthesiology

QUICKANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

AIM (N/A)

FDA 510(k)

FDA Class 2 ·Anesthesiology

R2-MRI ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AMIGO ESCORT 7.5, MODEL 760001 PHS

FDA 510(k)

FDA Class 2 ·Physical Medicine

REGEN BIOCEMENT

FDA 510(k)

FDA Class 2 ·Dental

Geon (S2) Nasal Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUNGLASS GALLERY INC. SUNGLASS

FDA 510(k)

FDA Class 1 ·Ophthalmic

Reveal

FDA registration

AMERICAN SCREENING CORPORATION·4 products·🇺🇸 United States

CardioChek Home Chol+HDL+GLU Test Strip

FDA registration

Polymer Technology Systems·4 products·🇺🇸 United States

HDL Cholesterol Reagent Kit

FDA registration

JAS Diagnostics/Drew Scientific·3 products·🇺🇸 United States

cardiochek Plus Test System, Cardiochek Home Test System

FDA registration

East West Wisconsin·4 products·🇺🇸 United States

STANDARD LipidoCare Home System

FDA registration

SD BIOSENSOR, INC.·4 products·🇰🇷 South Korea

Sekisui Diagnostics P.E.I. Inc.

FDA registration

Sekisui Diagnostics P.E.I. Inc.·3 products·🇨🇦 Canada

STANDARD LipidoCare Home System

FDA registration

SD Biosensor, Inc.·4 products·🇰🇷 South Korea

CardioChek PA

FDA registration

Polymer Technology Systems·4 products·🇺🇸 United States

PINSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXIT ALARM

FDA 510(k)

FDA Class 1 ·General Hospital