14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
FDA 510(k)
FDA Class 2
·Anesthesiology
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761969094·Pad head section G
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761976146·Trumpf Medical/Medizin Pad head section G
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·November 28, 2023
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C
FDA 510(k)
FDA Class 2
·Ophthalmic
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·June 12, 2023
BD INSYTE ¿ IV CATHETER WINGED
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 27, 2017
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABS.·Product code FTM·April 24, 2013
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·July 21, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 22, 2021
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 22, 2021
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014