Biomedical Enterprises, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biomedical Enterprises, Inc.” (first 2002, latest 2016), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 101 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 | 1 | 137 |
| 2014 | 3 | 91 |
| 2015 | 2 | 99 |
| 2016 | 1 | 240 |
| 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | 4 | 4 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| JEY | Plate, Bone | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (8)
- Dental (2)
Most recent Biomedical Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153573 | Converge | HRS | 2016-08-11 | 240 |
| K150125 | Elite Nitinol Fixation System | JDR | 2015-05-11 | 111 |
| K143023 | Nitinol Compression Plating System | HRS | 2015-01-16 | 87 |
| K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | JDR | 2014-11-17 | 91 |
| K133270 | SPEED ARC | JDR | 2014-04-17 | 176 |
| K133520 | HAMMERLOCK 2 | HTY | 2014-01-09 | 55 |
| K124022 | SPEED SHIFT | JDR | 2013-05-14 | 137 |
| K061385 | OSSTAPLE, OSSPLATE, OSSFORCE | KWQ | 2007-05-30 | 377 |
| K023488 | OSSTAPLE, CRANIOFACIAL | JEY | 2002-10-31 | 14 |
| K023486 | OSSTAPLE, MAXILLOFACIAL | JEY | 2002-10-31 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Biomedical Enterprises, Inc..
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.
- Biomedical Life Systems, Inc. (37 510(k)s)
- Biomedical Ent., Inc. (13 510(k)s)
- Biomedical Diagnostics (Bmd) SA (10 510(k)s)
- Biomedical Dynamics, Inc. (10 510(k)s)
- Biomedical Devices, Inc. (7 510(k)s)
- Biomedical Concepts, Inc. (3 510(k)s)
- Biomedical Design Instruments (3 510(k)s)
- Biomedical Research & Development Laboratories, Inc. (3 510(k)s)
- Biomedical Sensors, Inc. (3 510(k)s)
- Biomedical Systems Corp. (3 510(k)s)
- Biomedical Composites, Ltd. (2 510(k)s)
- Biomedical Exports, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomedical Enterprises, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Biomedical Enterprises, Inc.” (first 2002, latest 2016), across 5 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 Biomedical Enterprises, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedical Enterprises, Inc. is 101 days.
Which FDA product codes appear under Biomedical Enterprises, Inc.?
The most frequent FDA product codes under this applicant name are JDR (Staple, Fixation, Bone, 4); HRS (Plate, Fixation, Bone, 2); JEY (Plate, Bone, 2).
Next steps
- See all 10 Biomedical Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDR, Biomedical Enterprises, 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.