16 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number S702, ALTRUA 2 DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number U125, VALITUDE CRT-P EL
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number S701 ALTRUA 2 SR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
ACCOLADE DR SL (Model L301)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: DYNJ61984C; 9. TAVR PACK, Medline Kit SKU Number: DYNJ62310B; 10. HEART TAVR PACK, Medline Kit SKU Number: DYNJ65174G; 11. FEMORAL CARDIAC CATH, Medline Kit SKU Number: DYNJ66343A; 12. CARDIAC CATH PACK, Medline Kit SKU Number: DYNJ66693C; 13. TAVR PACK, Medline Kit SKU Number: DYNJ67225C; 14. AFIB TRAY, Medline Kit SKU Number: DYNJ85069; 15. AFIB TRAY, Medline Kit SKU Number: DYNJ85069A; 16. AFIB TRAY, Medline Kit SKU Number: DYNJ85069B; 17. MTO,LEFT HEART,KIT, Medline Kit SKU Number: VASC1811. Namic medical convenience kits, containing Namic Manifold, Labeled as: 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS,4 VALVE,LFT,HRT,KIT, Medline Kit Number/SKU 60010468; 3. MTO,ADD,ON,KIT, Medline Kit Number/SKU 60010469; 4. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 5. MTS,LFT,HRT,KIT, Medline Kit Number/SKU 60012911; 6. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60012912; 7. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013001; 8. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013101; 9. MTS,LFT,HRT,W/WIRE, Medline Kit Number/SKU 60013112; 10. MTS,-,3V,KIT, Medline Kit Number/SKU 60020608; 11. MTO,ANGIO,KIT, Medline Kit Number/SKU 60032681; 12. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 13. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60033124; 14. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60034644; 15. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60040273; 16. MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 60040424; 17. MTS,3,VAVLE,KIT, Medline Kit Number/SKU 60041082; 18. MTS,2V,KIT, Medline Kit Number/SKU 60042453; 19. MTO,3V,KIT, Medline Kit Number/SKU 60042454; 20. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60042721; 21. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 22. MTS,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 60060268; 23. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60060564; 24. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60060569; 25. MTS, Medline Kit Number/SKU 60062021; 26. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60071232; 27. MTO,CATH,LAB,KIT, Medline Kit Number/SKU 60080221; 28. MTO,RIGHT, Medline Kit Number/SKU 60080347; 29. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 30. MTS,MANIFOLD,KIT, Medline Kit Number/SKU 60080716; 31. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60081001; 32. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60081002; 33. MTO,LEFT,HRT(RT,HANDED), Medline Kit Number/SKU 60081168; 34. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60090123; 35. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60091111; 36. MTS,EP,KIT, Medline Kit Number/SKU 60100056; 37. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 38. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60100339; 39. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60110273; 40. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60110701; 41. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60120693; 42. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60121817; 43. MTO,CATH,KIT, Medline Kit Number/SKU 60130124; 44. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60130318; 45. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 46. MTO,RT HEART,KIT, Medline Kit Number/SKU 60131323; 47. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 48. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131554; 49. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131815; 50. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026