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Data / FDA device clearances / Oregon

FDA device clearances in Oregon: 174 since Nov 2024

The full list. FDA device clearances for applicants in Oregon: 174 rows for $8.70, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 6 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/oregon, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 29, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 174 device decisions for applicants in Oregon from November 15, 2024 to October 29, 2026: 32 510(k) clearances and De Novo grants and 142 PMA approvals and supplements, for 16 applicants. The newest, K262570 on October 29, 2026, is TZ Medical Birthing Balloon Kit from TZ Medical.

The request: Every new FDA device clearance or approval for a company in Oregon, with its address, the device and the product code. $10 of credit on sign-up, no card.

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

  • 174Decisions
  • 32510(k) and De Novo
  • 142PMA
  • October 29, 2026Latest decision

Newest decisions

The newest 100 of 174, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 29, 2026K262570TZ Medical Birthing Balloon KitTZ MedicalOregonSubstantially Equivalent510(k) traditionalPFJaccessdata.fda.gov
October 28, 2026P950037/S300Amvia Sky DR-T, Amvia Sky SR-T; Amvia Edge DR-T, Amvia Edge SR-T; Solvia Rise DR-T, Solvia Rise SR-T; Amvia...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
October 22, 2026P980023/S153Ilivia Neo 7 VRT DX, Intica Neo 7 VRT DX, Intica Neo 5 VRT DX, Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
October 22, 2026P950037/S299Edora 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...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
October 22, 2026P070008/S184Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeNKEaccessdata.fda.gov
October 22, 2026P050023/S216Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
October 22, 2026P000009/S135Ilivia Neo 7 DRT, Intica Neo 7 DRT, Intica Neo 5 DRT, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
October 16, 2026P950037/S289BIOexpressBiotronik, Inc.OregonApprovedPMA 180-day supplementDXYaccessdata.fda.gov
October 16, 2026P070008/S177BIOexpressBiotronik, Inc.OregonApprovedPMA 180-day supplementNKEaccessdata.fda.gov
October 16, 2026P050023/S209BIOexpressBiotronik, Inc.OregonApprovedPMA 180-day supplementMRMaccessdata.fda.gov
October 16, 2026P000009/S128BIOexpressBiotronik, Inc.OregonApprovedPMA 180-day supplementMRMaccessdata.fda.gov
October 13, 2026P980023/S152Ilivia Neo 7 VR-T DX DF-1 ProMRI, Ilivia Neo 7 VR-T DF-1 ProMRI, Intica Neo 7 VR-T DX DF-1 ProMRI, Intica Neo...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
October 13, 2026P950037/S298Edora 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...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
October 13, 2026P070008/S183Edora 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-TBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeNKEaccessdata.fda.gov
October 13, 2026P050023/S215Ilivia 7 VR-T DX DF-1 ProMRI Ilivia 7 VR-T DF-1 ProMRI Ilivia 7 VR-T DF4 ProMRI Intica 7 VR-T DX DF-1 ProMRI...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
October 13, 2026P000009/S134Intica Neo 7 DR-T DF-1 ProMRI, Intica Neo 5 DR-T DF-1 ProMRIBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
October 9, 2026P980023/S149Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura VR-T 482015; Acticor...Biotronik, Inc.OregonApprovedPMA real-time process supplementLWSaccessdata.fda.gov
October 9, 2026P950037/S296Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evity 6 DR-T 407149...Biotronik, Inc.OregonApprovedPMA real-time process supplementDXYaccessdata.fda.gov
October 9, 2026P070008/S181Edora 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...Biotronik, Inc.OregonApprovedPMA real-time process supplementNKEaccessdata.fda.gov
October 9, 2026P050023/S213Acticor Sky HF-T 481986; Rivacor Sky HF-T 481991; Rivacor Rise HF-T 482017; Rivacor Aura HF-T 482013; Acticor...Biotronik, Inc.OregonApprovedPMA real-time process supplementMRMaccessdata.fda.gov
October 9, 2026P000009/S132Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura DR-T 482014Biotronik, Inc.OregonApprovedPMA real-time process supplementMRMaccessdata.fda.gov
October 5, 2026P070008/S182Edora 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...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeNKEaccessdata.fda.gov
September 29, 2026K263073Fast Absorbing PGLARiverpoint Medical, LLCOregonSubstantially Equivalent510(k) specialGAMaccessdata.fda.gov
September 25, 2026P980023/S151Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
September 25, 2026P980023/S140Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569Biotronik, Inc.OregonApprovedPMA 180-day supplementLWSaccessdata.fda.gov
September 25, 2026P950037/S279Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149...Biotronik, Inc.OregonApprovedPMA 180-day supplementDXYaccessdata.fda.gov
September 25, 2026P070008/S172Edora 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...Biotronik, Inc.OregonApprovedPMA 180-day supplementNKEaccessdata.fda.gov
September 25, 2026P050023/S214Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, Rivacor Sky...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
September 25, 2026P050023/S204Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7...Biotronik, Inc.OregonApprovedPMA 180-day supplementMRMaccessdata.fda.gov
September 25, 2026P000009/S133Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T, Acticor 7 DR-T, Rivacor 7 DR-T...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
September 25, 2026P000009/S124Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568Biotronik, Inc.OregonApprovedPMA 180-day supplementMRMaccessdata.fda.gov
September 17, 2026P980023/S146Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky...Biotronik, Inc.OregonApprovedPMA real-time process supplementLWSaccessdata.fda.gov
September 17, 2026P950037/S291PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky DR-T, Amvia Sky...Biotronik, Inc.OregonApprovedPMA real-time process supplementDXYaccessdata.fda.gov
September 17, 2026P070008/S179PSW 2601.U, NEO 2601.UBiotronik, Inc.OregonApprovedPMA real-time process supplementNKEaccessdata.fda.gov
September 17, 2026P050023/S211PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky...Biotronik, Inc.OregonApprovedPMA real-time process supplementMRMaccessdata.fda.gov
September 17, 2026P000009/S130PSW 2601.U, NEO 2601.U, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-TBiotronik, Inc.OregonApprovedPMA real-time process supplementMRMaccessdata.fda.gov
September 10, 2026P980023/S150Pamira S 60; Pamira S 65; Pamira S 75; Pamira SD 60/16; Pamira SD 65/16; Pamira SD 65/18; Pamira SD 75/18...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
August 27, 2026P950037/S297Solia CSP SBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
August 27, 2026K262677Iconix Knotless TRiverpoint MedicalOregonSubstantially Equivalent510(k) specialMBIaccessdata.fda.gov
July 1, 2026P980023/S148Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
July 1, 2026P950037/S295Solia T 53, Solia T 60, Solia S 45, Solia S 53, Solia S 60, Solia CSP S 53, Solia CSP S 60Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
June 24, 2026P980023/S147Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015)...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
June 24, 2026P050023/S212Acticor 7 VR-T DX (429525); Acticor 7 VR-T DF4 ProMRI (429526); Rivacor 3 VR-T DF4 ProMRI (429574); Rivacor 5...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
June 24, 2026P000009/S131Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014)Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
June 5, 2026P210037/S017Prospera Spinal Cord Stimulation (SCS) System; Resilience Percutaneous Lead; Embrace One; TrueLockBiotronik Nro, Inc.Oregon30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
May 28, 2026P950037/S293Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
May 22, 2026K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.OregonSubstantially Equivalent510(k) traditionalDXCaccessdata.fda.gov
May 15, 2026P950037/S292Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker ElectrodesBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
May 14, 2026P210037/S012Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote ManagementBiotronik Nro, Inc.OregonApprovedPMA real-time process supplementLGWaccessdata.fda.gov
May 7, 2026P980023/S145Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
May 7, 2026P950037/S290Edora 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, Edora 8...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
May 7, 2026P070008/S178Edora 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, Amvia Sky...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeNKEaccessdata.fda.gov
May 7, 2026P050023/S210Acticor 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...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
May 7, 2026P000009/S129Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-TBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
May 1, 2026K261074BIOMONITOR IV (471155)Biotronik, Inc.OregonSubstantially Equivalent510(k) specialMXDaccessdata.fda.gov
April 24, 2026P950037/S285Renamic NeoBiotronik, Inc.OregonApprovedPMA real-time process supplementDXYaccessdata.fda.gov
April 24, 2026P210037/S015Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote ManagementBiotronik Nro, Inc.Oregon30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
April 24, 2026P070008/S175Renamic NeoBiotronik, Inc.OregonApprovedPMA real-time process supplementNKEaccessdata.fda.gov
April 24, 2026P050023/S207Renamic NeoBiotronik, Inc.OregonApprovedPMA real-time process supplementMRMaccessdata.fda.gov
April 24, 2026P000009/S127Renamic NeoBiotronik, Inc.OregonApprovedPMA real-time process supplementMRMaccessdata.fda.gov
April 2, 2026P950037/S288Solia CSP S LeadsBiotronik, Inc.OregonApprovedPMA 180-day supplementNVNaccessdata.fda.gov
March 30, 2026P950037/S282Amvia-Solvia Pulse Generators Scan Duration ExtensionBiotronik, Inc.OregonApprovedPMA real-time process supplementDXYaccessdata.fda.gov
March 27, 2026P950037/S287Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
March 25, 2026K252023MiraChlor Antimicrobial Wound SolutionLetus CorporationOregonSubstantially Equivalent510(k) traditionalFROaccessdata.fda.gov
March 11, 2026K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLCOregonSubstantially Equivalent510(k) traditionalMBIaccessdata.fda.gov
March 5, 2026P980023/S144Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015)...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
March 5, 2026P950037/S286Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
March 5, 2026P070008/S176Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeNKEaccessdata.fda.gov
March 5, 2026P050023/S208Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
February 27, 2026K253695LigaMendRiverpoint Medical, LLCOregonSubstantially Equivalent510(k) traditionalMBIaccessdata.fda.gov
February 12, 2026P950037/S280Solia CSP S 53; Solia CSP S 60Biotronik, Inc.OregonApprovedPMA 180-day supplementNVNaccessdata.fda.gov
February 11, 2026P980023/S142PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
February 11, 2026P950037/S283DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
February 11, 2026P050023/S205TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEADBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
February 11, 2026P000009/S125PHYLAX AV ICD SYSTEMBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
February 3, 2026P980023/S143PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
February 3, 2026P950037/S284DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
February 3, 2026P070008/S174STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeNKEaccessdata.fda.gov
February 3, 2026P050023/S206TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEADBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
February 3, 2026P000009/S126PHYLAX AV ICD SYSTEMBiotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
December 19, 2025K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.OregonSubstantially Equivalent510(k) traditionalPNEaccessdata.fda.gov
December 18, 2025P980023/S136Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor...Biotronik, Inc.OregonApprovedPMA 180-day supplementLWSaccessdata.fda.gov
December 18, 2025P950037/S274Solia S 53 377177; Solia S 60 377179Biotronik, Inc.OregonApprovedPMA 180-day supplementDXYaccessdata.fda.gov
December 18, 2025P050023/S199Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor...Biotronik, Inc.OregonApprovedPMA 180-day supplementMRMaccessdata.fda.gov
December 18, 2025P000009/S120Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014Biotronik, Inc.OregonApprovedPMA 180-day supplementMRMaccessdata.fda.gov
December 10, 2025P950037/S281Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
December 10, 2025P070008/S173Sentus ProMRI OTW QP S-75; Sentus ProMRI OTW QP S-85; Sentus ProMRI OTW QP S-95; Sentus ProMRI OTW QP L-75...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeNKEaccessdata.fda.gov
November 26, 2025K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.OregonSubstantially Equivalent510(k) traditionalNLHaccessdata.fda.gov
November 12, 2025K253290XSTAT P15Revmedx, Inc.OregonSubstantially Equivalent510(k) traditionalPGZaccessdata.fda.gov
October 29, 2025P980023/S141Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
October 24, 2025P950037/S272Edora 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...Biotronik, Inc.OregonApprovedPMA 135-day supplementDXYaccessdata.fda.gov
October 24, 2025P070008/S167Edora 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...Biotronik, Inc.OregonApprovedPMA 135-day supplementNKEaccessdata.fda.gov
October 24, 2025P050023/S196Acticor 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...Biotronik, Inc.OregonApprovedPMA 135-day supplementMRMaccessdata.fda.gov
October 23, 2025P210037/S013Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLockBiotronik Nro, Inc.Oregon30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
October 17, 2025K250145Biopsy Port AdapterEndosound, Inc.OregonSubstantially Equivalent510(k) traditionalODCaccessdata.fda.gov
October 16, 2025P980023/S139Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeLWSaccessdata.fda.gov
October 16, 2025P950037/S278Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeDXYaccessdata.fda.gov
October 16, 2025P070008/S171Edora 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...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeNKEaccessdata.fda.gov
October 16, 2025P050023/S203Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7...Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov
October 16, 2025P000009/S123Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568Biotronik, Inc.Oregon30-day notice acceptedPMA 30-day noticeMRMaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Biotronik, Inc.137October 28, 2026
Biotronik Nro, Inc.7June 5, 2026
Surgical Instrument Service and Savings, Inc.6December 19, 2025
Riverpoint Medical, LLC5September 29, 2026
Riverpoint Medical5August 27, 2026
Acumed, LLC4August 21, 2025
TZ Medical1October 29, 2026
Tz Medical, Inc.1May 22, 2026
Letus Corporation1March 25, 2026
Revmedx, Inc.1November 12, 2025
Endosound, Inc.1October 17, 2025
The Tmj Clinic PC1September 17, 2025
Narnar, LLC1July 14, 2025
Brain Electrophysiology Laboratory Company, LLC1April 10, 2025
Dci International, LLC1February 19, 2025
Surgical Instrument Service and Savings Inc.(Dba Medline Ren1November 15, 2024

By panel

PanelDecisionsLatest
Cardiovascular145October 28, 2026
Orthopedic11August 27, 2026
Neurology8June 5, 2026
General, Plastic Surgery4September 29, 2026
Dental2September 17, 2025
Obstetrics/Gynecology1October 29, 2026
Unknown1March 25, 2026
Gastroenterology, Urology1October 17, 2025
Radiology1July 14, 2025

By decision type

Decision typeDecisionsLatest
PMA 30-day notice82October 28, 2026
PMA real-time process supplement29October 9, 2026
PMA 180-day supplement24October 16, 2026
510(k) traditional21October 29, 2026
510(k) special9September 29, 2026
PMA special supplement4October 1, 2025
PMA 135-day supplement3October 24, 2025
510(k) abbreviated2September 17, 2025

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.