2,619 results · 48ms · Sources: EU EUDAMED, US FDA

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UNI-GRAFT K DV PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

SKIN NEUVEAU SCAR TREATMENT

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

OCEAN CHEST DRAIN

FDA 510(k)
FDA Class 2 ·General Hospital

SILK*SKIN SCAR TREATMENT

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ATRIUM PROLITE S MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ATRIUM PROLITE ULTRA S MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

IVENA VASCULAR PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

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

Dimension Vista® LOCI 4 CAL

FDA UDI
Siemens Healthcare Diagnostics Inc.·00842768033827·LOCI 4 Calibrator, 10 (2A x 2.0 mL; 2B x 2.0 mL...

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

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

Azure Cielo Dx

FDA UDI
Azure Biosystems Inc.·00860006465605·

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

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

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACANALYSIS CDX

TRUPCR® Bacterial / Fungal DNA Extraction Kit

Device
EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·On the market