209 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS
ActTrust
FDA 510(k)
FDA Class 2
·Neurology
Mini-OSTEO Pedicle Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MOTILITY CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMPACT DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Rainbow 360
FDA 510(k)
FDA Class 2
·Dental
WRIST PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EDGE SYRINGES AND NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
Pulse Oximeter (MD300M/MD300K2)
FDA 510(k)
FDA Class 2
·Cardiovascular
GEMORE MUSCLE CONDITIONER;
FDA 510(k)
FDA Class 2
·Physical Medicine
FINGERTIP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electronic Stethoscope DS301
FDA 510(k)
FDA Class 2
·Cardiovascular
FINGERTIP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
FDA 510(k)
FDA Class 2
·Radiology
Red Wave Hair Removal
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BROADMASTER HEALTHCARE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Air Compression Therapy System
FDA 510(k)
FDA Class 2
·Physical Medicine