4,464 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OMTech Desktop Laser Engraver
FDA Enforcement
Class II
·Ongoing·Rygel Advanced Machines d/b/a Omtech Laser·June 19, 2024
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Enforcement
Class II
·Ongoing·DICOM Grid, Inc. d/b/a Ambra Health·October 5, 2022
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 Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 17, 2024
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00 BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00 BD Pyxis" CIISafe, V9.X, SGL IM, BIO, / 10885403512520 / 111-221 BD Pyxis" CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO / N/A / 111-194 BD Pyxis" MedBank Tower / 10885403512568 / 169-29 BD Pyxis" CIISafe, V8.X Desktop PC, Bio / N/A / 107-245-01 Supply Server / N/A / N/A CCE Enterprise SW Site License (2-5) / N/A / N/A BD Pyxis" Logistics / N/A / 806 BD Pyxis" SupplyStation" V9 / N/A / 317 Security Module / N/A / 139698-01 Supply itParActive RF V11 / N/A / 138566-01 BD Knowledge Portal for Medication Technologies / N/A / 136607-01 STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-02 PRS STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-01 STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-02 PRS STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-01 BD Pyxis" CII Safe ES, Desktop PC / N/A / 1156-00 BD Pyxis" SupplyStation" Panel PC V11 / N/A / 1132-00 Pyxis" SupplyRoller V11 / N/A / 1127-00 Dell 640 Server / N/A / 1128-00 BD Pyxis" SupplyStation" System V11 / N/A / 1123-00 BD Pyxis" SupplyRoller V10 / N/A / 1101-00 BD Pyxis" SupplyStation" System V10 / **** / 347 BD Pyxis CII Safe,V9.X DESKTOP PC / **** / 107-252-01 BD Pyxis CII Safe,V7.X,DBL INTG MAIN,BIO,CLEAR DO 111-191 BD Pyxis CII Safe, V9.X, DBL IM, BIO, SLD DOORS / **** / 111-215 BD Care Coordination Engine (CCE) / **** / 134056-01 The Pyxis devices are automated medication dispensing cabinet that is intended to securely store and dispense medications to a qualified and authorized healthcare provider.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·September 3, 2025