15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
TECOMET, INC.
FDA registration
TECOMET, INC.·62 products·🇺🇸 United States
HYSTEROSCOPY PUMP HM6
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VASOGRAD DVT COMPRESSION GARMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·May 29, 2013
PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 21, 2008
K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
FDA Enforcement
Class II
·Terminated·Amendia, Inc·December 28, 2016