4,090 results
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53ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
FDA 510(k)
FDA Class 2
·Microbiology
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ORAQUICK HCV RAPID ANTIBODY TEST
Device To Detect Microbial Colonization Directly From Clinical Specimens.
FDA classification
FDA Class 2
·Device To Detect Microbial Colonization Directly From Clinical Specimens.
MobileECG 2 BT
FDA 510(k)
FDA Class 2
·Cardiovascular
ABT 4000 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
FDA 510(k)
FDA Class 2
·Radiology
OPTISTRAND, MODEL 1032S
FDA 510(k)
FDA Class 2
·Radiology
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
FDA 510(k)
FDA Class 2
·Radiology
THORA-DRAIN(R) ABT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SAFESTRETCH INCONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AAIO-7, AAIO WIRLESS
FDA 510(k)
FDA Class 2
·Ophthalmic
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
FDA 510(k)
FDA Class 2
·Ophthalmic
COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105
FDA 510(k)
FDA Class 2
·General Hospital
EXACON TEMP. PROBES SYSTEM 8000-#TH-103
FDA 510(k)
FDA Class 2
·General Hospital
EXACON SCIENTIFIC INSTRUMENTS APS
FDA 510(k)
FDA Class 2
·General Hospital
EXACON THERMOMETER SYSTEM 8000
FDA 510(k)
FDA Class 2
·General Hospital
Synapse Transcutaneous Electrical Stimulation Device
FDA 510(k)
FDA Class 2
·Neurology
Limbus Contour
FDA 510(k)
FDA Class 2
·Radiology
INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital