General Electric Co.: FDA filings under this applicant name

FDA lists 254 510(k) clearances under the applicant name “General Electric Co.” (first 1976, latest 2011), across 54 product codes in 6 review panels. Median 510(k) review time under this name: 43 days. 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 GE HealthCare, based on public ownership records.

510(k) clearances per year

Top product codes

Plus 44 more product codes.

Review panels

• Radiology (216)
• Cardiovascular (14)
• Obstetrics and Gynecology (5)
• Anesthesiology (2)
• General and Plastic Surgery (2)
• Neurology (1)

Most recent General Electric Co. 510(k) clearances

244 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named General Electric Co..

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.

SEC filings

GENERAL ELECTRIC CO (GE): EDGAR filings, CIK 40545. An SEC registrant with the same name, matched by name only.

Related HCPCS codes

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

• C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
• C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
• C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
• C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
• C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)

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.

• General Diagnostics (39 510(k)s)
• General Electric Medical Systems Information Techn (33 510(k)s)
• General Biometrics, Inc. (23 510(k)s)
• General Medical Co. (15 510(k)s)
• General Surgical Innovations (14 510(k)s)
• General X-Ray, Inc. (14 510(k)s)
• General Devices (13 510(k)s)
• General Physiotherapy, Inc. (9 510(k)s)
• General Medical Merate S.P.A (7 510(k)s)
• General Theraphysical, Inc. (7 510(k)s)
• General Atomics (6 510(k)s)
• General Electric Medical Systems (6 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under General Electric Co.?

FDA lists 254 510(k) clearances under the applicant name “General Electric Co.” (first 1976, latest 2011), across 54 product codes in 6 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 General Electric Co.?

The median time from FDA receipt to decision across 510(k)s cleared under the name General Electric Co. is 43 days.

Which FDA product codes appear under General Electric Co.?

The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 31); LNH (System, Nuclear Magnetic Resonance Imaging, 29); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 23).

Next steps

• See all 254 General Electric Co. clearances with predicates and recalls
• Run predicate analysis for product code JAK, General Electric Co.'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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