Medtronic, Inc.: FDA filings under this applicant name

FDA lists 247 510(k) clearances under 2 spellings of the applicant name “Medtronic, Inc.” (first 1981, latest 2026), plus 42 PMA decisions, across 96 product codes in 11 review panels. Median 510(k) review time under this name: 75 days. Since 2017 the median was 70 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Medtronic, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Medtronic, Inc. took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.

Top product codes

Plus 86 more product codes.

Review panels

• Cardiovascular (231)
• Orthopedic (17)
• General and Plastic Surgery (16)
• Neurology (6)
• Hematology (5)
• General Hospital (4)
• Gastroenterology and Urology (3)
• Radiology (3)
• Ear, Nose and Throat (2)
• Clinical Chemistry (1)
• Dental (1)

Most recent Medtronic, Inc. 510(k) clearances

237 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

323 product recalls in 67 recall events; 45 initiated in the last five years. Most recent: 2026-03-11.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Medtronic, Inc. is the lead sponsor of 16 device studies on ClinicalTrials.gov (8 active or recruiting). Most recent:

• NCT07507422: Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy (Recruiting, started 2026-04-17)
• NCT07005232: Lead Evaluation for Defibrillation and Reliability Post Approval Study (Enrolling by invitation, started 2026-01-07)
• NCT06637995: Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort (Completed, started 2025-01-27)
• NCT06048731: Enlighten Study: The EV-ICD Post Approval Registry (Active not recruiting, started 2023-09-01)
• NCT04543539: IN.PACT™ AV Access Post-Approval Study (PAS002) (Active not recruiting, started 2020-11-13)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medtronic, Inc. (a text match, not an official crosswalk):

• C1767 — Generator, neurostimulator (implantable), non-rechargeable (via LWP)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LKK)
• A4220 — Refill kit for implantable infusion pump (via LKK)
• E0783 — Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.) (via LKK)
• C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Medtronic, Inc. (255)
• Medtronic (34)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Medtronic Vascular (480 510(k)s)
• Medtronic Sofamor Danek (253 510(k)s)
• Medtronic Sofamor Danek USA, Inc. (184 510(k)s)
• Medtronic Minimed (57 510(k)s)
• Medtronic Xomed, Inc. (47 510(k)s)
• Medtronic Navigation, Inc. (44 510(k)s)
• Medtronic Perfusion Systems (29 510(k)s)
• Medtronic Neurosurgery (27 510(k)s)
• Medtronic Blood Systems, Inc. (15 510(k)s)
• Medtronic PS Medical (14 510(k)s)
• Medtronic Ave, Inc. (13 510(k)s)
• Medtronic Bio-Medicus, Inc. (13 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Medtronic, Inc.?

FDA lists 247 510(k) clearances under 2 spellings of the applicant name “Medtronic, Inc.” (first 1981, latest 2026), plus 42 PMA decisions, across 96 product codes in 11 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Medtronic, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic, Inc. is 75 days. Since 2017: 70 days, versus 109 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Medtronic, Inc.?

The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 31); MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), 17); DTZ (Oxygenator, Cardiopulmonary Bypass, 16).

Next steps

• See all 247 Medtronic, Inc. clearances with predicates and recalls
• Run predicate analysis for product code DWF, Medtronic, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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