44 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LapBox Tissue Containment Removal System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARK Voriconazole II Assay Test System
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARK CARE DIABETES MANAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CRK CONDYLAR RESURFACING TOTAL KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
FDA 510(k)
FDA Class 2
·Physical Medicine
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
FDA 510(k)
FDA Class 2
·General Hospital
Private Stock Labs Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JLK-PWI
FDA 510(k)
FDA Class 2
·Radiology
JLK-AILink
FDA 510(k)
FDA Class 2
·Radiology
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
FDA 510(k)
FDA Class 2
·Cardiovascular
JLK-ICH
FDA 510(k)
FDA Class 2
·Radiology
JLK-CTP
FDA 510(k)
FDA Class 2
·Radiology
JLK-SDH
FDA 510(k)
FDA Class 2
·Radiology
JBS-LVO
FDA 510(k)
FDA Class 2
·Radiology