81 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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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
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
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Enforcement
Class II
·Terminated·On Site Gas Systems Inc.·January 15, 2014
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
FDA Enforcement
Class II
·Terminated·Linde Gas North America Llc·June 26, 2013
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
FDA Enforcement
Class II
·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
FDA Enforcement
Class II
·Ongoing·Draegerwerk Ag & Co. Kgaa·February 7, 2024
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