Biodan Medical Systems, Ltd.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Biodan Medical Systems, Ltd.” (first 1982, latest 1993), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | 3 | 3 |
| ISD | Exerciser, Measuring | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | 2 |
| EXY | Uroflowmeter | 1 | 1 |
| INO | Chair, Positioning, Electric | 1 | 1 |
| IOL | Treadmill, Powered | 1 | 1 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
| IZD | Probe, Uptake, Nuclear | 1 | 1 |
Plus 4 more product codes.
Review panels
- Physical Medicine (9)
- Radiology (7)
- Microbiology (2)
- Clinical Chemistry (1)
- Gastroenterology and Urology (1)
Most recent Biodan Medical Systems, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | IZD | 1993-09-07 | 126 |
| K930261 | RTM REHABILITATION TREADMILL, MODEL #945-200 | IOL | 1993-05-26 | 127 |
| K930262 | TREATMENT TABLE, MODEL #825-100 | INO | 1993-03-29 | 69 |
| K930259 | TRACTION TABLE MODEL #825-200 | JFB | 1993-03-24 | 64 |
| K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES | IYX | 1993-02-12 | 73 |
| K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT | IZI | 1992-12-30 | 29 |
| K922591 | UROLOGICAL C-ARM TABLE, MODEL #056-450 | IXR | 1992-11-27 | 178 |
| K922605 | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 | IYO | 1992-10-20 | 140 |
| K922604 | DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE | IYO | 1992-10-20 | 140 |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | IKK | 1992-07-23 | 15 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biodan Medical Systems, Ltd..
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 Biodan Medical Systems, Ltd.?
FDA lists 20 510(k) clearances under the applicant name “Biodan Medical Systems, Ltd.” (first 1982, latest 1993), across 14 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 Biodan Medical Systems, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biodan Medical Systems, Ltd. is 66 days.
Which FDA product codes appear under Biodan Medical Systems, Ltd.?
The most frequent FDA product codes under this applicant name are IKK (System, Isokinetic Testing And Evaluation, 3); ISD (Exerciser, Measuring, 3); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 20 Biodan Medical Systems, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IKK, Biodan Medical Systems, Ltd.'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.