304 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
Access PCT
FDA 510(k)
FDA Class 2
·Microbiology
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
FDA 510(k)
FDA Class 2
·Microbiology
DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
FDA 510(k)
FDA Class 2
·Microbiology
Access PCT, Access PCT Calibrators
FDA 510(k)
FDA Class 2
·Microbiology
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
FDA classification
FDA Class 2
·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
EMISSION TOMOGRAPHY CAROUSEL
FDA 510(k)
FDA Class 2
·Radiology
A.S.D. SAFETY TROCAR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
FDA 510(k)
FDA Class 2
·Neurology
SLEEP SYSTEM FOR CLINICS & RESEARCH
FDA 510(k)
FDA Class 2
·Anesthesiology
CLIMAX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
FDA 510(k)
FDA Class 2
·Neurology
AIXPLORER
FDA 510(k)
FDA Class 2
·Radiology
Suture, Nonabsorbable, Synthetic, Polypropylene
FDA Pre-Market Approval
FDA Class 2
·GORE-TEX(R) SUTURE
Suture, Nonabsorbable, Synthetic, Polypropylene
FDA Pre-Market Approval
FDA Class 2
·GORE-TEX SUTURE WITH PLEDGETS
TransFix/EDTA Vacuum Blood Collection Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DoubleChek DC-1001
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
FDA 510(k)
FDA Class 2
·Radiology
KIDNEY PERFUSION MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat