2,418 results · 41ms · Sources: EU EUDAMED, US FDA

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·MyChoice® CDx

FDA Pre-Market Approval
BRACAnalysis CDx®

IR056 Synermed HDL-Cholesterol Reagent

FDA registration
Infrared Laboratory Systems dba SYNERMED·2 products·🇺🇸 United States

HDL-Cholesterol Assay

FDA registration
Diazyme Laboratories, Inc.·2 products·🇺🇸 United States

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ACCENT, IDENTITY, IDENTITY ADX, INTEGRITY ADX, VERITY ADX, VICTORY, ZEPHER, MICRONY PACEMAKERS

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTRITEX TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA LEAD

PTS Panels Metabolic ChemistryTest Strips (15-ct)

FDA UDI
POLYMER TECHNOLOGY SYSTEMS, INC.·00381932400015·PTS Panels® Metabolic Chemistry test strips are...

NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

FDA 510(k)
FDA Class 2 ·Ophthalmic

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx (F1CDx)

CT Trueview

FDA UDI
Philips Medical Systems Nederland B.V.·00884838064782·Software medical device, used with a Philips In...