33 results
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23ms
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Sources: EU EUDAMED, US FDA
ADVANTA SUPER SOFT GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741131769·
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040015537·Retreat w/Epi
Sledgehammer
FDA UDI
Keystone Industries·H66810004991·HC 5 llb Pwd Original
TEWA
FDA UDI
asia-med GmbH·04251282511388·TeWa CJ-Type 3075(s) Safe-T Sleeve: uncoated a...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282504069·TeWa CJ-Type 3075(s) Safe-T Sleeve: uncoated a...
GeneXpert Infinity-80 System
FDA UDI
CEPHEID·07332940004002·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004990·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004990·
CAMLOG SCREW IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CORTEK MINI LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-11 8. 799-EGL2-02-15 9. 799-EGL2-02-16 10. 799-EMBP-05-01 11. 799-EMBP-05-02 12. 799-EMBP-05-08 13. 799-EMBP-05-10 14. 799-EMBP-05-11 15. 799-EMBP-05-12 16. 799-EMBP-05-12-68 17. 799-EMBP-05-16 18. 799-EMBP-05-23 19. 799-EMVP-05 20. 799-EMVP-05-01 21. 799-EMVP-05-05 22. 799-EMVP-05-10 23. 799-EMVP-05-15 24. 799-EMVP-05-16 Manual Part Numbers 906-0731-01; 9650-002365-01 (US); 906-0731-01-05 (CAN); 906-0731-01-10; 9650-0002363-01; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 906-0731-01; 906-0731-01-05 (CAN); 906-0731-01-04; 906-0731-01-05; 906-0731-01-08; 906-0731-01-10; 906-0731-01-11; 906-0731-01-15; 906-0731-01-16; 9650-0002363-01; 9650-0002363-02; 9650-0002363-08; 9650-0002363-10; 9650-0002363-11; 9650-0002363-12; 9650-0002363-16; 9650-0002363-23; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 9650-0002363-10; 9650-0002363-15; 9650-0002363-16 Quick Reference Guide (QRG) Part Numbers: 907-0731-04; 9652-000499-01; 9652-000511-01; 907-0731-04; 9652-000511-01; 907-0731-04; 9652-000499-01; 9652-000499-04; 9652-000499-08; 9652-000499-10; 9652-000499-11; 907-0731-04; 9652-000499-16; 9652-000511-01; 9652-000511-02; 9652-000511-08; 9652-000511-10; 9652-000511-11; 9652-000511-12; 9652-000511-16; 9652-000511-23; 907-0731-04; 9652-000511-01; 9652-000511-05; 9652-000511-10; 9652-000511-15; 9652-000511-16
FDA Recall
Open, Classified
·ZOLL Medical Corporation·Product code CBK·April 30, 2024
INSORB 30 STAPLER
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code GDW·October 27, 2023
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·March 12, 2013
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·January 31, 2011
PRECISION LINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 14, 2008
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·October 20, 2025
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-11 8. 799-EGL2-02-15 9. 799-EGL2-02-16 10. 799-EMBP-05-01 11. 799-EMBP-05-02 12. 799-EMBP-05-08 13. 799-EMBP-05-10 14. 799-EMBP-05-11 15. 799-EMBP-05-12 16. 799-EMBP-05-12-68 17. 799-EMBP-05-16 18. 799-EMBP-05-23 19. 799-EMVP-05 20. 799-EMVP-05-01 21. 799-EMVP-05-05 22. 799-EMVP-05-10 23. 799-EMVP-05-15 24. 799-EMVP-05-16 Manual Part Numbers 906-0731-01; 9650-002365-01 (US); 906-0731-01-05 (CAN); 906-0731-01-10; 9650-0002363-01; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 906-0731-01; 906-0731-01-05 (CAN); 906-0731-01-04; 906-0731-01-05; 906-0731-01-08; 906-0731-01-10; 906-0731-01-11; 906-0731-01-15; 906-0731-01-16; 9650-0002363-01; 9650-0002363-02; 9650-0002363-08; 9650-0002363-10; 9650-0002363-11; 9650-0002363-12; 9650-0002363-16; 9650-0002363-23; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 9650-0002363-10; 9650-0002363-15; 9650-0002363-16 Quick Reference Guide (QRG) Part Numbers: 907-0731-04; 9652-000499-01; 9652-000511-01; 907-0731-04; 9652-000511-01; 907-0731-04; 9652-000499-01; 9652-000499-04; 9652-000499-08; 9652-000499-10; 9652-000499-11; 907-0731-04; 9652-000499-16; 9652-000511-01; 9652-000511-02; 9652-000511-08; 9652-000511-10; 9652-000511-11; 9652-000511-12; 9652-000511-16; 9652-000511-23; 907-0731-04; 9652-000511-01; 9652-000511-05; 9652-000511-10; 9652-000511-15; 9652-000511-16
FDA Enforcement
Class I
·Ongoing·ZOLL Medical Corporation·June 26, 2024
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006
FDA Recall
Terminated
·Synapse Biomedical Inc·Product code OIR·May 31, 2022