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

FDA registration

RANDOX LABORATORIES LIMITED·3 products·🇬🇧 United Kingdom

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

MEHOW INNOVATIVE (HUIZHOU) LTD.

FDA registration

MEHOW INNOVATIVE (HUIZHOU) LTD.·1 product·🇨🇳 China

ResMed Asia Pte. Ltd.

FDA registration

ResMed Asia Pte. Ltd.·1 product·🇸🇬 Singapore

RESMED PTY LTD.

FDA registration

RESMED PTY LTD.·1 product·🇦🇺 Australia

W&S PLASTICS PTY LTD

FDA registration

W&S PLASTICS PTY LTD·1 product·🇦🇺 Australia

RESMED CORP

FDA registration

RESMED CORP·1 product·🇺🇸 United States

RMO

FDA registration

RMO·1 product·🇲🇾 Malaysia

Ultra Mirage FFM

FDA registration

PPC MOULDING SERVICES PTY LTD·1 product·🇦🇺 Australia

C. DIFFICILE TOX A/B II

FDA registration

TECHLAB, INC.·1 product·🇺🇸 United States

C. DIFFICILE TOX A/B II

FDA registration

TECHLAB, INC.·1 product·🇺🇸 United States

Assay, Glycosylated Hemoglobin

FDA classification

FDA Class 2 ·Assay, Glycosylated Hemoglobin

Shockwave7578 (PT, SDB) - Shockwave Peripheral Intravascular Lithotripsy (IVL) System

FDA registration

Synergy Health AST, LLC·1 product·🇺🇸 United States

Colposcope (and Colpomicroscope)

FDA registration

Alltion (Guangxi) Instrument Co., Ltd.·1 product·🇨🇳 China

C. DIFFICILE TOX A/B II

FDA 510(k)

FDA Class 1 ·Microbiology

MINIME NASAL MASK, MODEL P/N 50220

FDA 510(k)

FDA Class 2 ·Anesthesiology

Reagents, Clostridium Difficile Toxin

FDA classification

FDA Class 1 ·Reagents, Clostridium Difficile Toxin

Ventilator, Non-Continuous (Respirator)

FDA classification

FDA Class 2 ·Ventilator, Non-Continuous (Respirator)