Worldwide Medical Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Worldwide Medical Corp.” (first 1989, latest 2002), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 218 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 |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
Most recent Worldwide Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020869 | FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) | DKZ | 2002-06-11 | 85 |
| K993852 | FIRST CHECK HOME DRUG TEST PANEL 4 | LAF | 2000-11-29 | 383 |
| K994139 | FIRST CHECK HOME DRUG TEST PANEL 2 | LDJ | 2000-06-23 | 199 |
| K994138 | FIRST CHECK HOME DRUG TEST PANEL 3 | LDJ | 2000-06-23 | 199 |
| K993663 | FIRST CHECK HOME DRUG TEST (THC) | LDJ | 2000-06-23 | 238 |
| K912270 | POLYCATH #WMC-900 | DQO | 1992-08-05 | 441 |
| K894401 | BALLOON THERMODILUTION CATHETERS | DQO | 1990-04-19 | 304 |
| K891843 | RANK PATIENT EXAM GLOVES (MFG. INTER-CONTINENTAL) | LYY | 1989-06-06 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Worldwide Medical Corp..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Worldwide Medical Corp. (5)
- Worldwide Medical (3)
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.
- Worldwide Medical Technologies, LLC (15 510(k)s)
- Worldwide Dental, Inc. (4 510(k)s)
- Worldwide Surgical Gauze (4 510(k)s)
- Worldwide Medical, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Worldwide Medical Corp.?
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Worldwide Medical Corp.” (first 1989, latest 2002), across 5 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 Worldwide Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Worldwide Medical Corp. is 218 days.
Which FDA product codes appear under Worldwide Medical Corp.?
The most frequent FDA product codes under this applicant name are LDJ (Enzyme Immunoassay, Cannabinoids, 3); DQO (Catheter, Intravascular, Diagnostic, 2); DKZ (Enzyme Immunoassay, Amphetamine, 1).
Next steps
- See all 8 Worldwide Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code LDJ, Worldwide Medical Corp.'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.