ABBOTT QUICKSTART LDH,#5A31

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TECHNICON AXON SYSTEM REAGENT METHODS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ALT INCORPORATING DST

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO L-TYPE GOT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Infinity Creatinine

FDA registration

Fisher Diagnostics·13 products·🇺🇸 United States

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Latitude™ NXT Patient Management System (TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Latitude™ NXT Patient Management System (ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, AL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE™ NXT Remote Patient Management System, LATITUDE™Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NX

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

FDA Pre-Market Approval

FDA Class 3 ·Latitude™ NXT Patient Management System (COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE,

MiniACE™

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071120122·MiniACE™ Low Profile Antegrade Continence Enema...

NA

FDA UDI

ST. JUDE MEDICAL, INC.·05415067028907·Adapter Cable

MiniACE™ Low Profile Antegrade Continence Enema Button

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071118853·MiniACE™ Low Profile Antegrade Continence Enema...

MiniACE™

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071120146·MiniACE™ Low Profile Antegrade Continence Enema...

MiniACE™ Low Profile Antegrade Continence Enema Button

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071118709·MiniACE™ Low Profile Antegrade Continence Enema...

MiniACE™

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071120016·MiniACE™ Low Profile Antegrade Continence Enema...

MiniACE®

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071121433·MiniACE® Low Profile Antegrade Continence Enema...

MiniACE™

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071120085·MiniACE™ Low Profile Antegrade Continence Enema...