NA

FDA UDI

MEDTRONIC, INC.·00613994501035·PIN PLUG 6725 US CONNECTOR PORT

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P)

ACCU NEWS Ovulation Test + Pregnancy Test Combo

FDA UDI

CORETESTS, INC.·00850042559017·70 pcs/box

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT

ARGUS LSM Pro, ARGUS LSM Patient Monitor

FDA registration

GUANGDONG BIOLIGHT MEDITECH CO., LTD·3 products·🇨🇳 China

M800 Handheld Monitor

FDA registration

GUANGDONG BIOLIGHT MEDITECH CO., LTD·3 products·🇨🇳 China

WELCH MEDICAL LLC

FDA registration

WELCH MEDICAL LLC·3 products·🇺🇸 United States

Wireless Electrocardiogram Patch

FDA registration

DREAMTECH CO., LTD.·3 products·🇰🇷 South Korea

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM VR (MODELS 1210 AND 1240) AND PLATINIUM DR (MODELS 1510 AND 1540) ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM CRT-D (MODELS 1711 AND 1741)

NA

FDA UDI

NIHON KOHDEN CORPORATION·04931921840276·NIBP, EXTENSION AIR HOSE, (S903)

Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)

FDA UDI

Xandar Kardian Korea Inc.·08809988780001·

NA

FDA UDI

NIHON KOHDEN AMERICA, INC.·00841983101762·NIBP, EXTENSION AIR HOSE, (S903)

SphygmoCor

FDA UDI

ATCOR MEDICAL PTY LTD·19351315000017·Packaged SphygmoCor CVMS systems including asse...

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODELS 2490G/2491DDMA

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA & SYNCRA CRT-PS IMPLANTABLE PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin

GenaCheck COVID-19 / Flu Rapid Self-Test Kit

FDA UDI

Genabio Diagnostics Inc.·00810143620092·

QuickProfile™ Covid-19/FluA&B Antigen Combo Test

FDA UDI

LUMIQUICK DIAGNOSTICS, INC.·00855636003808·The QuickProfile Covid-19/Influenza A&B Antigen...

Status™ COVID-19/Flu

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816001553·Status™ COVID-19/Flu A&B Antigen test kit, 25 t...