World of Medicine Lemke GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “World of Medicine Lemke GmbH” (first 2002, latest 2003), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| GCT | Light Source, Endoscope, Xenon Arc | 3 | 3 |
Review panels
Most recent World of Medicine Lemke GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024251 | SIGHTFIX | GCJ | 2003-03-18 | 85 |
| K023468 | ENDOSCOPIC LIGHT SOURCE XL180/L3 | GCT | 2003-01-14 | 90 |
| K021717 | ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 | GCT | 2002-08-20 | 89 |
| K021456 | ER150/M2 | GCJ | 2002-08-01 | 87 |
| K020889 | ENDOSCOPIC LIGHT SOURCE XL202/L3 | GCT | 2002-06-05 | 78 |
| K020336 | ENDOSCOPIC CAMERA MC404/C3 | GCJ | 2002-03-14 | 41 |
| K014158 | ENDOSCOPIC CAMERA TC804/C4 | GCJ | 2002-03-14 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named World of Medicine Lemke 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.
- World Bio Tech Co., Ltd. (2 510(k)s)
- World Precision Instruments, Inc. (2 510(k)s)
- World Book Encyclopedia, Inc. (1 510(k)s)
- World Class Technology Corporation (1 510(k)s)
- World Impex Corp. (1 510(k)s)
- World Metals, Inc. (1 510(k)s)
- World Spring Industries Corp. (1 510(k)s)
- World Trade Assoc. (1 510(k)s)
- World Wide EX Im, Inc. (1 510(k)s)
- World Wide Outdoor Marketing (1 510(k)s)
- World Wide Sun Systems, Inc. (1 510(k)s)
- World Wide Trade Network, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under World of Medicine Lemke GmbH?
FDA lists 7 510(k) clearances under the applicant name “World of Medicine Lemke GmbH” (first 2002, latest 2003), across 2 product codes in 2 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 World of Medicine Lemke GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name World of Medicine Lemke GmbH is 85 days.
Which FDA product codes appear under World of Medicine Lemke GmbH?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 4); GCT (Light Source, Endoscope, Xenon Arc, 3).
Next steps
- See all 7 World of Medicine Lemke GmbH clearances with predicates and recalls
- Run predicate analysis for product code GCJ, World of Medicine Lemke 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, 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.