Philips Ultrasound, Inc.: FDA filings under this applicant name

FDA lists 77 510(k) clearances under the applicant name “Philips Ultrasound, Inc.” (first 1985, latest 2026), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 40 days. Since 2017 the median was 75 days, against 120 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 Philips, 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 Philips Ultrasound, Inc. took a median 75 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.

Top product codes

Plus 1 more product codes.

Review panels

• Radiology (74)
• Cardiovascular (1)
• Obstetrics and Gynecology (1)

Most recent Philips Ultrasound, Inc. 510(k) clearances

67 earlier clearances. See the full list in Caduvo.

Recalls

140 product recalls in 30 recall events; 108 initiated in the last five years. Most recent: 2026-08-07.

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.

• Philips Medical Systems, Inc. (218 510(k)s)
• Philips Medical Systems (Cleveland), Inc. (190 510(k)s)
• Philips Medical Systems Nederland B.V. (106 510(k)s)
• Philips Medical Systems North America, Inc. (95 510(k)s)
• Philips Medizin Systeme Boeblingen GmbH (48 510(k)s)
• Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (25 510(k)s)
• Philips Health Care (20 510(k)s)
• Philips Hearing Instruments Co. (20 510(k)s)
• Philips Medical Systems Dmc GmbH (18 510(k)s)
• Philips Healthcare (Suzhou) Co., Ltd. (17 510(k)s)
• Philips Medizin Systeme Boblingen GmbH (12 510(k)s)
• Philips Int'L B.V. (11 510(k)s)

Frequently asked questions

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

FDA lists 77 510(k) clearances under the applicant name “Philips Ultrasound, Inc.” (first 1985, latest 2026), across 9 product codes in 3 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 Philips Ultrasound, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Ultrasound, Inc. is 40 days. Since 2017: 75 days, versus 120 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Philips Ultrasound, Inc.?

The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 51); LLZ (System, Image Processing, Radiological, 13); ITX (Transducer, Ultrasonic, Diagnostic, 3).

Next steps

• See all 77 Philips Ultrasound, Inc. clearances with predicates and recalls
• Run predicate analysis for product code IYN, Philips Ultrasound, 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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