14 results · 23ms · Sources: EU EUDAMED, 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