LetsGetChecked Saliva Sample Collection Kit

FDA registration

Privapath Diagnostics Ltd·1 product·🇮🇪 Ireland

LetsGetChecked Swab Sample Collection Kit

FDA registration

Privapath Diagnostics Ltd·1 product·🇮🇪 Ireland

WIN

FDA registration

DW Lingual Systems GmbH·1 product·🇩🇪 Germany

Idylla™ Console Software Plus (CSW+)

Device

EU IVDR · Eu Ivd Class A ·Biocartis NV·On the market

ALX Adaptor 3/8 inch BSW

Device

EU MDR · Eu Md Class 1 ·Koalaa Ltd·On the market·32 countries

BREATHE RIGHT NASAL STRIP

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

RHYTHMSTAR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPAT ENTERAL DELIVERY PUMP SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BREATHE RIGHT NASAL STRIP

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

SLEEP TEST(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1

FDA 510(k)

FDA Class 2 ·Cardiovascular

BREATHE RIGHT NASAL STRIP

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Here We Flo

FDA registration

Woodland Group Ltd·1 product·🇬🇧 United Kingdom

Here We Flo

FDA registration

Woodland Group Ltd·1 product·🇬🇧 United Kingdom

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

FDA Pre-Market Approval

FDA Class 3 ·SMART-MSP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SMART-MSP

IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry