BEUDAMED
    79 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 30, 2019

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Enforcement
    Class II ·Terminated·Paa Laboratories Inc·July 24, 2013

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    FDA Enforcement
    Class II ·Terminated·Miami Fat Supply, Inc·June 22, 2016

    AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    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

    AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q) B247C08062810, r) B247C08063210, s) B247C09062410, t) B247C09062810, u) B247C09063210, v) B247C10062410, w) B247C10062810, x) B247C10063210, y) B247C11062410, z) B247C11062810, aa) B247C11063210, bb) B247C12062410, cc) B247C12062810, dd) B247C12063210, ee) B247C13062410, ff) B247C13062810, gg) B247C13063210, hh) B247C14062410, ii) B247C14062810, jj) B247C14063210, kk) B247C15062810, ll) B247C15063210; intervertebral fusion device - lumbar

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·August 30, 2023

    GORE¿ EXCLUDER¿ AAA Endoprosthesis

    FDA Enforcement
    Class II ·Terminated·W. L. Gore & Associates Inc.·February 12, 2020

    AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    Endovascular AAA Pack, ESED52B; Medical convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·October 2, 2024

    Endovascular AAA Pack, ESED52B; Medical convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·October 2, 2024

    AFX Endovascular AAA System, Endoleak Type IIIA

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D

    FDA Enforcement
    Class II ·Ongoing·Welch Allyn Inc Mortara·October 13, 2021

    AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I16-30 F00820-28 BEA25-120/I20-40 F00820-29 BEA25-100/I20-40 F00820-30 BEA25-80/I20-40 F00820-43 BEA25-110/I20-30 F00820-44 BEA25-90/I20-30 F00820-45 BEA25-70/I20-30 F00820-57 BEA22-80/I20-40 F00820-71 BEA22-90/I20-30 F00820-72 BEA22-70/I20-30 The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017