77 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.
FDA Recall
Terminated
·Xstrahl Limited·Product code JAD·April 26, 2021
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Recall
Terminated
·Sensus Healthcare, Inc.·Product code JAD·February 10, 2023
Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy.
FDA Recall
Terminated
·Action Products Incorporated·Product code JAD·June 26, 2009
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
FDA Recall
Terminated
·Xstrahl Limited·Product code JAD·August 27, 2021
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012
INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code JAD·July 1, 2011
Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.
FDA Recall
Terminated
·Action Products Incorporated·Product code JAD·June 26, 2009
INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
FDA Recall
Terminated
·Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany·Product code JAD·August 30, 2017
Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.
FDA Recall
Terminated
·Greiner VACUETTE North America·Product code FPA·December 16, 2003
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code CGA·April 7, 2014
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code CFR·October 23, 2014
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.
FDA Enforcement
Class II
·Terminated·Camlog Usa·September 25, 2013
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.
FDA Enforcement
Class II
·Terminated·Talladium Inc·September 16, 2020
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
FDA Recall
Terminated
·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016
Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
FDA Recall
Terminated
·Contour Fabricators Inc·Product code EAJ·September 9, 2016
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020