15 results · 22ms · Sources: EU EUDAMED, 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