| Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014 (P000009/S120) | Biotronik, Inc. | 2025-12-18 |
| Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor Sky VR-T D (P980023/S136) | Biotronik, Inc. | 2025-12-18 |
| Solia S 53 377177; Solia S 60 377179 (P950037/S274) | Biotronik, Inc. | 2025-12-18 |
| Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q (P050023/S199) | Biotronik, Inc. | 2025-12-18 |
| Sentus ProMRI OTW QP S-75; Sentus ProMRI OTW QP S-85; Sentus ProMRI OTW QP S-95; Sentus ProMRI OTW QP L-75; Sentus ProMR (P070008/S173) | Biotronik, Inc. | 2025-12-10 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie (P950037/S281) | Biotronik, Inc. | 2025-12-10 |
| Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira SD 65/18 4 (P980023/S141) | Biotronik, Inc. | 2025-10-29 |
| Acticor 7 VR-T; Rivacor 7 VR-T; Rivacor 5 VR-T; Rivacor 3 VR-T; Acticor 7 VR-T DX; Rivacor 7 VR-T DX; Rivacor 5 VR-T DX; (P050023/S196) | Biotronik, Inc. | 2025-10-24 |
| Edora 8 HF-T QP; Edora 8 HF-T; Evity 8 HF-T QP; Evity 8 HF-T; Enitra 8 HF-T QP; Enitra 8 HF-T; Enticos 8 HF-T QP; Entico (P070008/S167) | Biotronik, Inc. | 2025-10-24 |
| Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 (P950037/S272) | Biotronik, Inc. | 2025-10-24 |
| Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (P000009/S123) | Biotronik, Inc. | 2025-10-16 |
| Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 (P980023/S139) | Biotronik, Inc. | 2025-10-16 |
| Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (P950037/S278) | Biotronik, Inc. | 2025-10-16 |
| Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H (P070008/S171) | Biotronik, Inc. | 2025-10-16 |
| Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I (P050023/S203) | Biotronik, Inc. | 2025-10-16 |
| Ilivia 7 VR-T DX; Intica 7 VR-T DX; Intica 5 VR-T DX; Ilivia 7 VR-T; Ilivia 7 DF4 VR-T; Intica 7 VR-T; Intica 7 DF4 VR-T (P050023/S202) | Biotronik, Inc. | 2025-10-01 |
| Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 (P950037/S277) | Biotronik, Inc. | 2025-10-01 |
| Ilivia Neo 7 DR-T; Intica Neo 7 DR-T; Intica Neo 5 DR-T (P000009/S122) | Biotronik, Inc. | 2025-10-01 |
| Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- (P980023/S138) | Biotronik, Inc. | 2025-10-01 |
| Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (P000009/S121) | Biotronik, Inc. | 2025-09-15 |
| Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- (P980023/S137) | Biotronik, Inc. | 2025-09-15 |
| Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Ilivia 7 DF4 VR-T 40462 (P050023/S201) | Biotronik, Inc. | 2025-09-15 |
| Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140; Enitra 8 HF-T QP 407141; Enitr (P070008/S170) | Biotronik, Inc. | 2025-09-15 |
| Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (P950037/S276) | Biotronik, Inc. | 2025-09-15 |
| Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (P950037/S275) | Biotronik, Inc. | 2025-09-11 |
| Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 (P070008/S169) | Biotronik, Inc. | 2025-09-11 |
| Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 (P050023/S200) | Biotronik, Inc. | 2025-09-11 |
| CardioMessenger Smart 4G (P050023/S197) | Biotronik, Inc. | 2025-08-22 |
| Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri (P050023/S198) | Biotronik, Inc. | 2025-06-18 |
| Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (P950037/S273) | Biotronik, Inc. | 2025-06-18 |
| Edora 8 HF-T QP 407137, Edora 8 HF-T 407138, Evity 8 HF-T QP 407139, Evity 8 HF-T 407140, Enitra 8 HF-T QP 407141, Enitr (P070008/S168) | Biotronik, Inc. | 2025-06-18 |
| Sentus QP Pacing Leads (P050023/S193) | Biotronik, Inc. | 2025-06-12 |
| Sentus QP Pacing Leads (P070008/S165) | Biotronik, Inc. | 2025-06-12 |
| Home Monitoring System Version 3.52.0 (P050023/S162) | Biotronik, Inc. | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P000009/S095) | Biotronik, Inc. | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P980023/S108) | Biotronik, Inc. | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P950037/S229) | Biotronik, Inc. | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P070008/S131) | Biotronik, Inc. | 2025-04-15 |
| Renamic Neo (P050023/S192) | Biotronik, Inc. | 2025-04-03 |
| Renamic Neo (P000009/S118) | Biotronik, Inc. | 2025-04-03 |
| Renamic Neo (P070008/S164) | Biotronik, Inc. | 2025-04-03 |
| Renamic Neo (P950037/S269) | Biotronik, Inc. | 2025-04-03 |
| Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q (P050023/S190) | Biotronik, Inc. | 2025-03-10 |
| Pamira S DX 65/15, Pamira S DX 65/17, Plexa ProMRI S DX 65/15, Plexa ProMRI S DX 65/17 (P980023/S133) | Biotronik, Inc. | 2025-03-10 |
| Safio S 53, Setrox S 53, Solia S 45, Solia S 53, Solia S 60, Siello S 45, Siello S 53, Siello S 60 (P950037/S267) | Biotronik, Inc. | 2025-03-10 |
| Corox (ProMRI) OTW 75 BP, Corox (ProMRI) OTW-S 75 BP, Corox (ProMRI) OTW-L 75 BP, Corox (ProMRI) OTW 85 BP, Corox (ProMR (P070008/S163) | Biotronik, Inc. | 2025-03-10 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S135) | Biotronik, Inc. | 2025-03-05 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S271) | Biotronik, Inc. | 2025-03-05 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T (P050023/S195) | Biotronik, Inc. | 2025-03-05 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S119) | Biotronik, Inc. | 2025-03-05 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, (P050023/S194) | Biotronik, Inc. | 2025-02-20 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico (P070008/S166) | Biotronik, Inc. | 2025-02-20 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S270) | Biotronik, Inc. | 2025-02-20 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR (P980023/S134) | Biotronik, Inc. | 2025-02-05 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S117) | Biotronik, Inc. | 2025-02-05 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S268) | Biotronik, Inc. | 2025-02-05 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T (P050023/S191) | Biotronik, Inc. | 2025-02-05 |
| Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP (P950037/S266) | Biotronik, Inc. | 2024-12-06 |
| Enitra 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Enitra 8 HF-T QP, Evity 8 HF-T, Evity 8 HF-T QP (P070008/S162) | Biotronik, Inc. | 2024-12-06 |
| Acticor 7 DR-T DF4 ProMRI, Rivacor 3 DR-T DF4 ProMRI, Rivacor 5 DR-T DF4 ProMRI, Rivacor 7 DR-T DF4 ProMRI, Acticor 7 HF (P050023/S189) | Biotronik, Inc. | 2024-12-06 |
| Intica Neo 5 DR-T DF-1 ProMRI, Ilivia Neo 7 DR-T DF-1 ProMRI, Intica Neo 7 DR-T DF-1 ProMRI (P000009/S116) | Biotronik, Inc. | 2024-12-06 |
| Ilivia Neo 7 VR-T DF-1 ProMRI, Ilivia Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 5 VR-T DF-1 ProMRI, Intica Neo 5 VR-T DX DF- (P980023/S132) | Biotronik, Inc. | 2024-12-06 |
| NEO 2401.U/1 (P950037/S262) | Biotronik, Inc. | 2024-12-05 |
| NEO 2401.U/1 (P070008/S159) | Biotronik, Inc. | 2024-12-05 |
| NEO 2401.U/1 (P000009/S114) | Biotronik, Inc. | 2024-12-05 |
| NEO 2401.U/1 (P050023/S187) | Biotronik, Inc. | 2024-12-05 |
| Defibrillator, Implantable, Dual-Chamber (P000009/S115) | Biotronik, Inc. | 2024-10-25 |
| Implantable Cardioverter Defibrillator (Non- Crt) (P980023/S131) | Biotronik, Inc. | 2024-10-25 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S160) | Biotronik, Inc. | 2024-10-25 |
| Pulse Generator, Permanent, Implantable (P950037/S264) | Biotronik, Inc. | 2024-10-25 |
| Implantable Cardioverter Defibrillator (Non- Crt), Defibrillator, Implantable, Dual-Chamber, Defibrillator, Automatic Im (P050023/S188) | Biotronik, Inc. | 2024-10-25 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S161) | Biotronik, Inc. | 2024-10-25 |
| Solia S 45, Solia S 53, Solia S 60, Solia JT 45, Solia JT 53, Solia T 53, Solia T 60 (P950037/S265) | Biotronik, Inc. | 2024-10-21 |
| Solia S Leads (P950037/S261) | Biotronik, Inc. | 2024-10-11 |
| PK-175/2,3m Patient Cable, PK-83, 2.5m (P950037/S263) | Biotronik, Inc. | 2024-10-09 |
| TW Torque wrench (P980023/S130) | Biotronik, Inc. | 2024-10-09 |
| Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6 (P980023/S129) | Biotronik, Inc. | 2024-09-21 |
| Ilivia Neo 7 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo (P000009/S113) | Biotronik, Inc. | 2024-09-03 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T (P050023/S186) | Biotronik, Inc. | 2024-09-03 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T (P980023/S128) | Biotronik, Inc. | 2024-09-03 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P), Pulse Generator, Permanent, Implantable (P950037/S255) | Biotronik, Inc. | 2024-08-30 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S260) | Biotronik, Inc. | 2024-08-15 |
| Pulse Generator, Permanent Implantable (P950037/S259) | Biotronik, Inc. | 2024-07-31 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, (P050023/S179) | Biotronik, Inc. | 2024-06-21 |
| PSW 2401.U, NEO 2401.U (P050023/S183) | Biotronik, Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P070008/S157) | Biotronik, Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P950037/S257) | Biotronik, Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P000009/S110) | Biotronik, Inc. | 2024-06-13 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, automatic implantable cardioverter, with cardiac resync (P050023/S185) | Biotronik, Inc. | 2024-05-29 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S127) | Biotronik, Inc. | 2024-05-29 |
| Defibrillator, implantable, dual-chamber (P000009/S112) | Biotronik, Inc. | 2024-05-29 |
| Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60, (P980023/S126) | Biotronik, Inc. | 2024-05-19 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 (P950037/S258) | Biotronik, Inc. | 2024-05-19 |
| Ilivia Neo 7 DR-T (P000009/S111) | Biotronik, Inc. | 2024-05-19 |
| Intica Neo 7 HF -T, Intica Neo 7 HF -T QP, BS IS4 (P050023/S184) | Biotronik, Inc. | 2024-05-19 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S158) | Biotronik, Inc. | 2024-05-19 |
| Acticor 7 HF-T, Rivacor 7 HF -T, Rivacor 5 HF -T, Rivacor 3 HF-T, Acticor 7 HF-T QP, Rivacor 7 HF T QP, Rivacor 5 HF T (P050023/S180) | Biotronik, Inc. | 2024-05-09 |
| Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T, Rivacor 3 DR-T (P000009/S107) | Biotronik, Inc. | 2024-05-09 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR, -T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T D (P980023/S124) | Biotronik, Inc. | 2024-05-09 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 (P950037/S256) | Biotronik, Inc. | 2024-05-02 |