523 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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NOVA CO-OXIMETER ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
GII SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANGIOLAZ ANGIOSCOPE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STAT PROFILE PHOX ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
Integrity V500 (Integrity, Integrity with VEMP)
FDA 510(k)
FDA Class 2
·Neurology
VIVOSONIC NEUROSCREEN
FDA 510(k)
FDA Class 2
·Neurology
SAM CRRT Unit, SAM Cassette CRRT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endotoxin Activity Assay (EAA)
FDA 510(k)
FDA Class 2
·Microbiology
SPECTRAL WEST NILE VIRUS IGM STATUS TEST
FDA 510(k)
FDA Class 2
·Microbiology
ProCell Surgical Sponge-Blood Recovery Unit
FDA 510(k)
FDA Class 2
·Anesthesiology
BI-FLEX URETERAL ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHADEBACT MONOCLONAL GC TEST, MODIFICATION
FDA 510(k)
FDA Class 2
·Microbiology
ENDOFLOW II - Irrigation, Warming and Suction System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RocaJJ Soft Stents
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROCAMED ROCAUS PLATINUM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RocaTub Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology