23 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
Natus
FDA UDI
XLTEK·00382830010979·Protektor 32 Acquisition Box
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746105210·BRACKET NARROW TWIN MAX BICUSPID 018 TQ=0 A=0 R...
BEHRING COAGULATION SYSTEM, MODEL BCS
FDA 510(k)
FDA Class 2
·Hematology
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
FDA 510(k)
FDA Class 2
·Neurology
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code LFL·June 2, 2006
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
ENDURANT II ABDOMINAL STENT GRAFT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·March 13, 2013
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·February 28, 2011
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12MM DIAMETER,100 MM LENGTH
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GCJ·February 4, 2008
EQUINOXE COMPRESSION SCREW
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2025
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015