14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Anatotemp Anatomic Dental Implant Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
VOCARE MYHEALTH TABLET
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
FDA 510(k)
FDA Class 2
·Orthopedic
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·May 11, 2022
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013
PRISMAFLEX
FDA Adverse Event
Malfunction
·GAMBRO LUNDIA AB, MONITORS·Product code KDI·June 29, 2007
BD BACTEC MGIT 960 SUPPLEMENT KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·April 23, 2021
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·August 9, 2023
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
FDA Enforcement
Class II
·Ongoing·BioFire Diagnostics, LLC·August 30, 2023
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021