45 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NP1 Instrument, Creo Electrosurgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Paradigm
FDA UDI
Proprio, Inc.·00850042604052·Paradigm Blunt Probe
ReLine
FDA UDI
Nuvasive, Inc.·00195377045263·RELINE-O Trial, 7mm H Lamina N L-pop
ThinPrep®
FDA UDI
Hologic, Inc.·15420045508408·CytoLyt® Solution for use as a cell wash and tr...
OptumSI Implant System
FDA UDI
SI Solutions, LLC·00850057247039·Exchange Guide Pin
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399000835·SMALL SAGITTAL SAW BLADE, 12.7mm X 24.3mm X 0.5mm
ARKEO, Wedge Fixation System
FDA UDI
Auxano Medical LLC·00810199190211·The ARKEO Wedge Fixation System (Preliminary Ki...
JEWELERS PRECISION FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059337·JEWELERS PRECISION FORCEPS ANGLED TIPS #5 SERRA...
Lapiplasty SpeedPlate
FDA UDI
Treace Medical Concepts, Inc.·00810111221221·Inserter Cap
OsteoMed
FDA UDI
OSTEOMED LLC·00845694005579·1.6mm Pilot Drill, J-Latch
MICROETCHER
FDA UDI
DANVILLE MATERIALS, LLC·00816594021570·MICROETCHER II,JETLESS
Optoacoustic Imaging System
FDA Pre-Market Approval
FDA Class 3
·Imagio Breast Imaging System
Clarius Ultrasound Scanner
FDA UDI
Clarius Mobile Health Corp·07540205000540·Clarius brand C3-45 scanner
OsteoMed
FDA UDI
OSTEOMED LLC·00845694066143·2.0 System 1.6mm Pilot Drill J-Latch Sterile Qty 2
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
FDA 510(k)
FDA Class 2
·Cardiovascular
TORNIER TOTAL ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Optoacoustic Imaging System
FDA Pre-Market Approval
FDA Class 3
·Imagio® Breast Imaging system
SOFTFORM FACIAL IMPLANT
FDA Adverse Event
Injury
·TISSUE TECHNOLOGIES, INC.·Product code FTL·June 27, 2000
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 31, 2016
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 22, 2013