Biomedical Ent., Inc.: FDA clearances and approvals
Biomedical Ent., Inc. has 13 FDA 510(k) clearances (first 1996, latest 2014), across 5 product codes in 4 review panels. Median 510(k) review time: 97 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 134 |
| 2014 | 2 | 104 |
| 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | 6 | 6 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| HBW | Fastener, Plate, Cranioplasty | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
Review panels
- Orthopedic (8)
- General and Plastic Surgery (3)
- Dental (1)
- Neurology (1)
Most recent Biomedical Ent., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133844 | SPEED TRIAD | JDR | 2014-04-07 | 110 |
| K133780 | SPEED XL | JDR | 2014-03-19 | 97 |
| K131640 | SMOOTH OR THREADED METALLIC BONE FASTENER | HTY | 2013-10-16 | 134 |
| K102107 | OSSTAPLE CHILL | JDR | 2010-09-03 | 38 |
| K091951 | HAMMERLOCK | HTY | 2010-02-19 | 233 |
| K023203 | OSSTAPLE | JDR | 2002-10-17 | 22 |
| K001354 | MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM | JDR | 2001-03-13 | 319 |
| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | HBW | 2001-03-13 | 319 |
| K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM | JEY | 2000-06-21 | 65 |
| K993714 | MEMOGRAPH STAPLE, WARM SYSTEM | JDR | 2000-02-25 | 115 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biomedical Ent., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biomedical Ent., Inc. have?
Biomedical Ent., Inc. has 13 FDA 510(k) clearances (first 1996, latest 2014), across 5 product codes in 4 review panels.
How long does FDA take to clear Biomedical Ent., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biomedical Ent., Inc.'s cleared 510(k)s is 97 days.
What devices does Biomedical Ent., Inc. make?
Its most frequent FDA product codes are JDR (Staple, Fixation, Bone, 6); GEY (Motor, Surgical Instrument, Ac-Powered, 3); HTY (Pin, Fixation, Smooth, 2).
Has Biomedical Ent., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biomedical Ent., Inc. Related entities may recall under other names.
Next steps
- See all 13 Biomedical Ent., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDR, Biomedical Ent., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.