Worldwide Medical Technologies, LLC: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Worldwide Medical Technologies, LLC” (first 1998, latest 2007), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 6 | 6 |
| KNW | Instrument, Biopsy | 3 | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| IWJ | System, Applicator, Radionuclide, Manual | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
Review panels
- Radiology (8)
- General and Plastic Surgery (4)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent Worldwide Medical Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062214 | BRACHYSCIENCES STRANDPORT | KXK | 2007-03-01 | 212 |
| K023179 | READI-STRAND, MODEL PSSTRAND | KXK | 2003-07-02 | 281 |
| K022705 | READI-STRAND, MODEL PSSTRAND | KXK | 2003-06-09 | 299 |
| K022389 | READI-LOAD SYSTEM, MODEL PSS 1820RL | KXK | 2003-05-06 | 287 |
| K020641 | SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 | BZD | 2002-10-29 | 244 |
| K020337 | READI-STRAND; MODEL PSSTRAND | KXK | 2002-07-29 | 178 |
| K020867 | BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL | KNW | 2002-05-20 | 63 |
| K991344 | WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS | KXK | 1999-11-05 | 200 |
| K981889 | WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE | FCG | 1998-07-31 | 63 |
| K982097 | WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD | FMI | 1998-06-25 | 10 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-08-12.
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.
- Worldwide Medical Corp. (9 510(k)s)
- Worldwide Dental, Inc. (4 510(k)s)
- Worldwide Surgical Gauze (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Worldwide Medical Technologies, LLC?
FDA lists 15 510(k) clearances under the applicant name “Worldwide Medical Technologies, LLC” (first 1998, latest 2007), across 8 product codes in 5 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 Technologies, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Worldwide Medical Technologies, LLC is 84 days.
Which FDA product codes appear under Worldwide Medical Technologies, LLC?
The most frequent FDA product codes under this applicant name are KXK (Source, Brachytherapy, Radionuclide, 6); KNW (Instrument, Biopsy, 3); BZD (Ventilator, Non-Continuous (Respirator), 1).
Next steps
- See all 15 Worldwide Medical Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code KXK, Worldwide Medical Technologies, LLC'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.