108 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
FDA 510(k)
FDA Class 2
·Orthopedic
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
BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML
FDA 510(k)
FDA Class 2
·General Hospital
FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC
FDA 510(k)
FDA Class 2
·General Hospital
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
FDA 510(k)
FDA Class 2
·Cardiovascular
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
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
Bi-Flex Evo
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology