2,254 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
FDA 510(k)
FDA Class 2
·Dental
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
FDA 510(k)
FDA Class 2
·Neurology
TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
FDA 510(k)
FDA Class 2
·Anesthesiology
GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).
Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XLO Brand of Locking Distal Humerus Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
LiverMultiScan
FDA 510(k)
FDA Class 2
·Radiology
HD BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MIRADA RTX
FDA 510(k)
FDA Class 2
·Radiology
Balloon Inflation System
FDA 510(k)
FDA Class 2
·Orthopedic
Digital Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHECK MULTIPLE DRUG CUP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Diode laser therapy device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ilumien Optis, Optis Integrated, Optis Mobile
FDA 510(k)
FDA Class 2
·Radiology