Olympus Winter & Ibe GmbH: FDA filings under this applicant name

FDA lists 43 510(k) clearances under the applicant name “Olympus Winter & Ibe GmbH” (first 1997, latest 2026), across 20 product codes in 7 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 93 days, against 123 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 Olympus, 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 Olympus Winter & Ibe GmbH took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.

Top product codes

Plus 10 more product codes.

Review panels

• General and Plastic Surgery (17)
• Gastroenterology and Urology (16)
• General Hospital (4)
• Obstetrics and Gynecology (3)
• Ear, Nose and Throat (1)
• Neurology (1)
• Orthopedic (1)

Most recent Olympus Winter & Ibe GmbH 510(k) clearances

33 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Olympus Winter & Ibe GmbH.

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.

• Olympus Medical Systems Corp. (190 510(k)s)
• Olympus Corp. (149 510(k)s)
• Olympus America, Inc. (149 510(k)s)
• The Olympus Optical Co. (26 510(k)s)
• Olympus Optical Co., Ltd. (22 510(k)s)
• Olympus Surgical Technologies America (14 510(k)s)
• Olympus Diagnostica GmbH (4 510(k)s)
• Olympus Life & Material Science Europa GmbH (Irish (3 510(k)s)
• Olympus Life Science Research Europa GmbH (Europa) (3 510(k)s)
• Olympus Terumo Biomaterials Corporation (3 510(k)s)
• Olympus Corp of America (2 510(k)s)
• Olympus Opto-Electronics Co., Ltd. (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Olympus Winter & Ibe GmbH?

FDA lists 43 510(k) clearances under the applicant name “Olympus Winter & Ibe GmbH” (first 1997, latest 2026), across 20 product codes in 7 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 Olympus Winter & Ibe GmbH?

The median time from FDA receipt to decision across 510(k)s cleared under the name Olympus Winter & Ibe GmbH is 94 days. Since 2017: 93 days, versus 123 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Olympus Winter & Ibe GmbH?

The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 13); FAS (Electrode, Electrosurgical, Active, Urological, 6); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 4).

Next steps

• See all 43 Olympus Winter & Ibe GmbH clearances with predicates and recalls
• Run predicate analysis for product code GEI, Olympus Winter & Ibe GmbH'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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