17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
FDA 510(k)
FDA Unclassified
·Unknown
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RENAL UROLOGY STENT K072293
FDA Adverse Event
Other
·FOSSA MEDICAL INC·Product code FAD·April 10, 2014
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC·Product code CBK·October 26, 2009
5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
BD LUER-LOK TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 27, 2021
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013
REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·March 18, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·June 17, 2008
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC.·Product code CBK·October 27, 2009
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022