449 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Cranial COVER
FDA 510(k)
FDA Class 2
·Neurology
Neuronaute with IceCap 2 & IceCap 2 Small
FDA 510(k)
FDA Class 2
·Neurology
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SMR Reverse HP Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip
FDA 510(k)
FDA Class 2
·Radiology
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
FDA 510(k)
FDA Class 2
·Radiology
Nerve Capping Device
FDA 510(k)
FDA Class 2
·Neurology
NEUROLAC(R) NERVE GUIDE
FDA 510(k)
FDA Class 2
·Neurology
FlexBoardTM, EagleBoardTM, BreastBoard SXTM
FDA 510(k)
FDA Class 2
·Radiology
WiEMSpro
FDA 510(k)
FDA Class 2
·Physical Medicine
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
FDA 510(k)
FDA Class 2
·Radiology
1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle
FDA 510(k)
FDA Class 2
·General Hospital
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
FDA 510(k)
FDA Class 2
·General Hospital
Laboratorios Biogalenic Sterile Water for Inhalation, USP
FDA 510(k)
FDA Class 2
·Anesthesiology
PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COBB SPINAL ELEVATORS
FDA 510(k)
FDA Class 2
·Orthopedic
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental