133 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ARK Fentanyl II Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
FDA 510(k)
FDA Class 2
·General Hospital
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
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
FDA 510(k)
FDA Class 2
·Neurology
SKIN CARE LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
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
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
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TENS
FDA 510(k)
FDA Class 2
·Neurology
TEETH IN AN HOUR - ARK IMPLANT CONCEPT
FDA 510(k)
FDA Class 2
·Dental
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
FDA 510(k)
FDA Class 2
·Physical Medicine
LOS 3D VISION 100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology