PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY

FDA 510(k)

FDA Class 2 ·Anesthesiology

PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS

FDA 510(k)

FDA Class 2 ·Anesthesiology

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ANTHRACIS REAL-TIME PCR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Variola virus Real-Time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Rickettsia Real-time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

FDA 510(k)

FDA Class 2 ·Microbiology

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD 2, CONTAK RENEWAL 3 DS, CONTAK RENEWAL 3 HE

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, CONTAK CD 2, EASYTRAK, CONTAK RENEWAL, CONTAK RENEWAL 3

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD 2 (MODELS H115, H119) AND APPLICATION SOFTWARE MODEL 2844

ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

Device

EU MDR · Eu Md Class 1 ·Sizewise Rentals LLC Raye's, Inc. D/B/A Sizewise Manufacturing·On the market

ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

Device

EU MDR · Eu Md Class 1 ·Sizewise Rentals LLC Raye's, Inc. D/B/A Sizewise Manufacturing·On the market

3M EDUMEX, S.A DE C.V

FDA registration

3M EDUMEX, S.A DE C.V·1 product·🇲🇽 Mexico

3M

FDA registration

3M EDUMEX, S.A DE C.V·1 product·🇲🇽 Mexico

Invisalign System with Mandibular Advancement – Precision Wings

FDA registration

Aligntech de Mexico S, de R. L. de C. V.·1 product·🇲🇽 Mexico

iTero Element 2

FDA registration

Aligntech de Mexico S, de R. L. de C. V.·1 product·🇲🇽 Mexico

Fresenius Combilines Blood Tubing Set

FDA registration

ERIKA DE REYNOSA, S.A. DE C.V.·1 product·🇲🇽 Mexico

CombiSet SMARTECH Hemodialysis Blood Tubing Sets

FDA registration

ERIKA DE REYNOSA, S.A. DE C.V.·2 products·🇲🇽 Mexico