Medtronic Xomed, Inc.: FDA filings under this applicant name

FDA lists 47 510(k) clearances under the applicant name “Medtronic Xomed, Inc.” (first 1996, latest 2026), plus 1 PMA decision, across 26 product codes in 8 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 147 days, against 114 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 Xomed, Inc. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.

Top product codes

Plus 16 more product codes.

Review panels

• Ear, Nose and Throat (30)
• Neurology (7)
• General and Plastic Surgery (4)
• Dental (2)
• Ophthalmic (2)
• Cardiovascular (1)
• Obstetrics and Gynecology (1)
• Orthopedic (1)

Most recent Medtronic Xomed, Inc. 510(k) clearances

37 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

38 product recalls in 25 recall events; 12 initiated in the last five years. Most recent: 2025-07-17.

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.

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, Inc. (247 510(k)s)
• Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
• Medtronic Minimed (57 510(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 Xomed, Inc.?

FDA lists 47 510(k) clearances under the applicant name “Medtronic Xomed, Inc.” (first 1996, latest 2026), plus 1 PMA decision, across 26 product codes in 8 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 Xomed, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Xomed, Inc. is 104 days. Since 2017: 147 days, versus 114 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Medtronic Xomed, Inc.?

The most frequent FDA product codes under this applicant name are ETN (Stimulator, Nerve, 10); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 8); ETD (Tube, Tympanostomy, 2).

Next steps

• See all 47 Medtronic Xomed, Inc. clearances with predicates and recalls
• Run predicate analysis for product code ETN, Medtronic Xomed, 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, with punctuation and legal suffixes removed; 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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