45 results
·
9ms
·
Sources: EU EUDAMED, US FDA
ACIES
FDA 510(k)
FDA Class 2
·Radiology
Solstice CCI
FDA 510(k)
FDA Class 2
·Orthopedic
INFINIX-CCI
FDA 510(k)
FDA Class 2
·Radiology
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
FDA 510(k)
FDA Class 2
·Radiology
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RASTRONICS CCI 8
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CUSTOM CRANIOFACIAL IMPLANT (CCI)
FDA 510(k)
FDA Class 2
·Neurology
MDx-Chex for BCY
FDA 510(k)
FDA Class 2
·Microbiology
BCI 3180 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BCI WW1030 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BCI WW1021 PC APPLICATION
FDA 510(k)
FDA Class 2
·Cardiovascular
ACI PULSATING VACUUM PUMP SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BCI 3401 HANDHELD PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES ACIS/VERTEBRAL SPACER CR
FDA 510(k)
FDA Class 2
·Orthopedic
BCI-100 FECAL INCONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACI SINGLE LUMEN BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
FDA 510(k)
FDA Class 2
·Hematology
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
FDA 510(k)
FDA Class 2
·Hematology
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
FDA 510(k)
FDA Class 2
·Cardiovascular