Biomedics: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biomedics” (first 1980, latest 1999), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| JEY | Plate, Bone | 6 | 6 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JXG | Shunt, Central Nervous System And Components | 1 | 1 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 1 | 1 |
Review panels
- Dental (6)
- Orthopedic (2)
- Neurology (1)
- Radiology (1)
Most recent Biomedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992330 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | 1999-11-23 | 134 |
| K984583 | THE BIOPLATE SHUNT CONNECTOR | JXG | 1999-03-15 | 81 |
| K980983 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | 1998-06-09 | 84 |
| K972463 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | 1997-09-25 | 86 |
| K961976 | THE BIOPLATE FIXATION SYSTEM | JEY | 1996-08-16 | 88 |
| K953273 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM | JEY | 1995-09-29 | 78 |
| K943071 | THE TITANIUM FIXATION SYSTEM | JEY | 1995-01-06 | 192 |
| K844787 | BIOMETRIC TOTAL HIP SYSTEM | JDI | 1985-04-19 | 130 |
| K842687 | BIOMEDICS BLADDER SCANNER | ITX | 1985-04-08 | 272 |
| K801345 | KAMPNER HINGED TOE PROSTHESIS | KWH | 1980-07-08 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Biomedics.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomedics?
FDA lists 10 510(k) clearances under the applicant name “Biomedics” (first 1980, latest 1999), across 5 product codes in 4 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 Biomedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedics is 87 days.
Which FDA product codes appear under Biomedics?
The most frequent FDA product codes under this applicant name are JEY (Plate, Bone, 6); ITX (Transducer, Ultrasonic, Diagnostic, 1); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 1).
Next steps
- See all 10 Biomedics clearances with predicates and recalls
- Run predicate analysis for product code JEY, Biomedics'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.