1,566 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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THD REVOLUTION
FDA 510(k)
FDA Class 2
·Radiology
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
FDA 510(k)
FDA Class 2
·Cardiovascular
MTS Omadacycline 0.002-32 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
ACE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
FDA 510(k)
FDA Class 2
·Dental
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
FDA 510(k)
FDA Class 2
·Cardiovascular
SENTINEL PLASMAPROTEINS CAL 3X
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PIEZOSURGERY PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
Physica LMC Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
SMR Reverse Liner
FDA 510(k)
FDA Class 2
·Orthopedic
CRONO SUPER PID
FDA 510(k)
FDA Class 2
·General Hospital
DRSplus
FDA 510(k)
FDA Class 2
·Ophthalmic
Filbloc
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Galaxy UNYCO System
FDA 510(k)
FDA Class 2
·Orthopedic
Screw Sleeve Bone Fixation Device, Spine
FDA classification
FDA Class 2
·Screw Sleeve Bone Fixation Device, Spine
Instruments Designed For Press-Fit Osteochondral Implants
FDA classification
FDA Class 2
·Instruments Designed For Press-Fit Osteochondral Implants
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM