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Sources: EU EUDAMED, US FDA
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ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Viewray, Inc.·Product code IYE·October 20, 2020
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Viewray, Inc.·Product code IYE·October 20, 2020
FPS 35mm x 3.5 mm non-locking screw
FDA Recall
Terminated
·Ortho Solutions Inc·Product code HWC·July 21, 2016
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number: 73325 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Recall
Open, Classified
·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023
Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A2
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.
FDA Recall
Terminated
·MDC Acquisition Co.·Product code FPS·April 23, 2010
Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
FDA Recall
Terminated
·Circadiance LLC·Product code NPE·May 1, 2017
APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Smartmonitor 2 with modem, PCMCIA model number 4003. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
FDA Recall
Terminated
·Respironics, Inc.·Product code NPF·October 15, 2007
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
FDA Recall
Terminated
·Spiegelberg Gmbh & Co. KG Tempowerkring 4 Hamburg Germany·Product code GWM·December 29, 2009
Regard, T AND A - Rogers, sterilized convenience kits
FDA Recall
Terminated
·ROi CPS LLC·Product code OGR·November 30, 2021
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OEZ·September 21, 2023