BEUDAMED
    10 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM

    FDA Enforcement
    Class II ·Terminated·U&I CORP.·July 29, 2020

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·October 10, 2018

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    FDA Enforcement
    Class II ·Ongoing·MAX LUX CORP·December 8, 2021

    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Enforcement
    Class II ·Terminated·X-NAV Technologies, LLC·April 20, 2016

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·November 16, 2022

    Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector

    FDA Enforcement
    Class II ·Terminated·Medisystems a NX Stage Company·January 30, 2013

    Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

    FDA Enforcement
    Class II ·Terminated·Medisystems a NX Stage Company·January 30, 2013

    XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA; f) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX; g) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA; h) XS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC; i) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA; j) XS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB; k) XS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB; l) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AA-BXAAA; m) XS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB; n) XS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX; o) XS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA; p) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB; q) XS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC; r) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX; s) XS6 WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB; t) XS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AA-CEBAB; u) XS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-DDBAB; v) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-DGAAA; w) XS6 WAM TTL SYS Z200 PCRT IEC DICOM, XSCRIBE-6AA-DGBAB; x) XS6 WAM TTL SYS Z200 PCRT IEC, XSCRIBE-6AA-DGBAX; y) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAAA; z) XS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-XFAAB; aa) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAXA; bb) XS6 WAM TTL SYS Z200 PCRT IEC XML, XSCRIBE-6AA-XFBXA; cc) XS6 WAM TTL SYS BCRT AHA, XSCRIBE-6AB-BEAXX; dd) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-BXAXA; ee) XS6 WAM TTL SYS Z200 BCRT AHA XML, XSCRIBE-6AB-CDAAA; ff) XS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AB-CDAAB; gg) XS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAA; hh) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAB; ii) XS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AB-CDBAC; jj) XS6 WAM TTL SYS BCRT AHA XML, XSCRIBE-6AB-CEAAA; kk) XS6 WAM TTL SYS BCRT IEC, XSCRIBE-6AB-CEBAX; ll) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-DDBAB; mm) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AB-DDBAX; nn) XS6 WAM TTL SYS BCRT IEC XML, XSCRIBE-6AB-DEBAA; oo) XS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AB-DEBAB; pp) XS6 WAM TTL SYS BCRT IEC SVR, XSCRIBE-6AB-DEBAC; qq) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAAA; rr) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAXA; ss) XS6 WAM TTLSYS Z200 BCRT AHA XML, XSCRIBE-6AB-XCAAA; tt) XS6 WAM TTLKIT Z200 AHA DICOM, XSCRIBE-6AC-AAAAB; uu) XS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAAX; vv) XS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAXX; ww) XS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAAX; xx) XS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAXX; yy) XS6 WAM TTL KIT BCRT AHA XML, XSCRIBE-6AC-AEAAA; zz) XS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-AEAXX; aaa) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAAA; bbb) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAXA; ccc) XS6 WAM TTL KIT AHA, XSCRIBE-6AC-AXAXX; ddd) XS6 WAM TTL KIT Z200 BCRT AHA DICOM, XSCRIBE-6AC-BDAAB; eee) XS6 WAM TTL KIT BCRT AHA SVR, XSCRIBE-6AC-BEAAC; fff) XS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-BEAXX; ggg) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-BXAXA; hhh) XS6 WAM TTL KIT AHA, XSCRIBE-6AC-BXAXX; iii) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-CDBAA; jjj) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-CDBAB; kkk) XS6 WAM TTL KIT BCRT IEC, XSCRIBE-6AC-CEBAX; lll) XS6 WAM TTL KIT IEC XML, XSCRIBE-6AC-CXBAA; mmm) XS6 WAM TTL KIT IEC DICOM, XSCRIBE-6AC-CXBAB; nnn) XS6 WAM TTL KIT Z200 IEC XML, XSCRIBE-6AC-DBBXA; ooo) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DCBXA; ppp) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DDBAA; qqq) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBAB; rrr) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBXB; sss) XS6 WAM TTL KIT BCRT IEC XML, XSCRIBE-6AC-DEBAA; ttt) XS6 WAM TTL KIT BCRT IEC

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024