28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HAD1717MC
FDA 510(k)
FDA Class 2
·Radiology
ReLine
FDA UDI
Nuvasive, Inc.·00195377047014·RELINE-O Trial, 6mm H Lamina Ang N L-pop
Paradigm
FDA UDI
Proprio, Inc.·00850042604212·Paradigm DRF Ratcheting Clamp
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399000958·SMALL SAGITTAL SAW BLADE, 10.2mm X 18.3mm X 0.5mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694005661·Ratcheting Screwdriver
Drill Bit
FDA UDI
Treace Medical Concepts, Inc.·00810111221597·Drill Bit - Short
WANGENSTEEN TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059405·WANGENSTEEN TISSUE FORCEPS TUNGSTEN CARBIDE SER...
STRABISMUS BABY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083479·STRABISMUS BABY SCISSORS STRAIGHT BLADE POWER C...
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
FDA Pre-Market Approval
FDA Class 3
·NeuRX Diaphragm Pacing System (DPS)
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
BRANEMARK NOVUM
FDA 510(k)
FDA Class 2
·Dental
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 13, 2016
Clarius Ultrasound Scanner
FDA UDI
Clarius Mobile Health Corp·07540205000328·
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MZO·October 24, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 10, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013
DEPTH GAUGE VARIAX DISTAL RADIUS, SCREWS Ø2.3/2.7X40MM, BLACK
FDA Adverse Event
Malfunction
·STRYKER GMBH (MDR)·Product code HRS·September 24, 2014
DEPTH GAUGE VARIAX DISTAL RADIUS, SCREWS Ø2.3/2.7X40MM, BLACK
FDA Adverse Event
Malfunction
·STRYKER GMBH (MDR)·Product code HRS·September 24, 2014
DEPTH GAUGE VARIAX DISTAL RADIUS, SCREWS Ø2.3/2.7X40MM, BLACK
FDA Adverse Event
Malfunction
·STRYKER GMBH (MDR)·Product code HRS·August 7, 2014