501 results · 22ms · Sources: EU EUDAMED, US FDA

MAKS CENTRAL DELIVERY SYS-11-200 ETC

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)

FDA 510(k)
FDA Class 2 ·General Hospital

MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

3-Ply Disposable Medical Mask

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

MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

NaviENT

FDA 510(k)
FDA Class 2 ·Neurology

POLYURETHANE SOLUTION 29% W/W

FDA 510(k)
FDA Class 2 ·Dental

Navident

FDA 510(k)
FDA Class 2 ·Dental

Navident

FDA 510(k)
FDA Class 2 ·Dental

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)

FDA 510(k)
FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)
FDA Class 2 ·Cardiovascular

EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled

FDA 510(k)
FDA Class 2 ·Cardiovascular

AVVIGO'+ Multi-Modality Guidance System

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUINTON STATUS 1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Cordiana Dx16

FDA 510(k)
FDA Class 2 ·Cardiovascular

HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0

FDA 510(k)
FDA Class 2 ·Cardiovascular