11 results
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13ms
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Sources: EU EUDAMED, US FDA
Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.
FDA Recall
Terminated
·Laserworld Usa Inc·Product code REA·July 19, 2012
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LLZ·December 22, 2015
Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The Capella R-1850 is a Class 4 solid state diode laser product designed to emit 1850mn laser radiation at maximum pulse energy of 5 mJ (@1ms). The output port connects to a user-selected 200-600 micron diameter optical fiber. The Capella R-1850 is labeled in part: "***LASER APERTURE***Aculight Corporation 22121 20th ave SE Bothell, WA 98021***Feb 2007***Model R-1850, SN: 007***".
FDA Recall
Terminated
·Product code RGB·November 19, 2010
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Recall
Terminated
·RGI Medical Manufacturing, Inc.·Product code FPA·March 28, 2014
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
FDA Recall
Terminated
·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code HGB·September 4, 2013
Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FGB·April 6, 2016
Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FGB·April 6, 2016
Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FGB·April 6, 2016
Uretero-reno fiberscope URF-P6RP6
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FGB·January 17, 2018
Uretero-reno fiberscope URF-P6
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FGB·January 17, 2018
Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes
FDA Recall
Terminated
·Richard Wolf Medical Instruments Corp.·Product code HGB·October 16, 2009