BEUDAMED
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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

    X80 RADiant Photoelectric Therapy System

    FDA Recall
    Open, Classified ·Xstrahl Limited·Product code JAD·April 27, 2022

    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

    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

    Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1: g) QS6 AM12Q TTL KIT AHA / QS-6AC-XXAXX: h) QS6 AM12Q TTL KIT AHA / QS-6AC-XXBXX: i) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXAXA: j) QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS: k) QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA: l) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA: m) QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA: n) QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA: o) QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS: p) QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB: q) QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA: r) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX: s) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX: t) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX: u) QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB: v) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA: w) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA: x) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA: y) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA: z) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA: aa) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA: bb) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA: cc) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA: dd) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB: ee) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB: ff) QS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC: gg) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA: hh) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA: ii) QS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA: jj) QS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB: kk) QS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX: ll) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA: mm) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA: nn) QS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX: oo) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB: pp) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB: qq) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX: rr) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA: ss) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX: tt) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX: uu) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA: vv) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA: ww) QS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA: xx) QS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA: yy) QS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB: zz) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB: aaa) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB: bbb) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1: ccc) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA: ddd) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA: eee) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA: fff) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1: ggg) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1: hhh) QS6 AM12QKIT AHA XML / QS-6CC-XXAXA: iii) QS6 AM12QKIT AHA / QS-6CC-XXBXX: jjj) QS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB: kkk) QS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX: lll) QS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX: mmm) QS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX: nnn) QS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA: ooo) QS6 AM12QSYS IEC XML / QS-6CB-CXCXA: ppp) QS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX: qqq) QS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA: rrr) QS6 NOACQMOD KIT NO LDSET XML / QS-6XC-XXXXA: sss) QS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX: ttt) QS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB: uuu) QS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA: vvv) QS6 PRO ENHANCED SECURITY / QS6-STTDX: www)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DPS·December 8, 2023

    VACUETTE SAFELINK, REF: 450210

    FDA Recall
    Open, Classified ·Greiner Bio-One GmbH Bad Haller Strase·Product code FMI·November 19, 2024

    ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device

    FDA Recall
    Open, Classified ·J & T Health and Wellness LLC·Product code LEJ·March 31, 2023