Biodan Medical Systems, Ltd.
Israel, IL
Biodan Medical Systems, Ltd. appears in FDA device records in Israel, IL. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Biodan Medical Systems, Ltd. between 1982 and 1993. The busiest year on record is 1992, with 11. The most recent is 1993, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1990 | 1 |
| 1992 | 11 |
| 1993 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | IZD | Substantially Equivalent | |
| K930261 | RTM REHABILITATION TREADMILL, MODEL #945-200 | IOL | Substantially Equivalent | |
| K930262 | TREATMENT TABLE, MODEL #825-100 | INO | Substantially Equivalent | |
| K930259 | TRACTION TABLE MODEL #825-200 | JFB | Substantially Equivalent | |
| K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES | IYX | Substantially Equivalent | |
| K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT | IZI | Substantially Equivalent | |
| K922591 | UROLOGICAL C-ARM TABLE, MODEL #056-450 | IXR | Substantially Equivalent | |
| K922605 | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 | IYO | Substantially Equivalent | |
| K922604 | DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE | IYO | Substantially Equivalent | |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | IKK | Substantially Equivalent | |
| K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | IKK | Substantially Equivalent | |
| K922606 | MULTI JOINT WEIGHT SYSTEM MODEL #940-100 | ISD | Substantially Equivalent | |
| K922603 | TOTAL WORK INTEGRATOR, MODEL #940-110 | ISD | Substantially Equivalent | |
| K922602 | CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 | ISD | Substantially Equivalent | |
| K922092 | SINGLE CHAIR INTEGRAL BACK ATTACHMENT | IKK | Substantially Equivalent | |
| K921501 | DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 | IZZ | Substantially Equivalent | |
| K900770 | HOME URODATA SYSTEM(TM) | EXY | Substantially Equivalent | |
| K840088 | BIODEX ACT-O-KIT TSH-RIA- | JLW | Substantially Equivalent | |
| K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | LHL | Substantially Equivalent | |
| K822066 | LEGIONELLA PNEUMOPHILA | LHL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- IYXCamera, Scintillation (Gamma)
- INOChair, Positioning, Electric
- ISDExerciser, Measuring
- IZDProbe, Uptake, Nuclear
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- IKKSystem, Isokinetic Testing And Evaluation
- IZISystem, X-Ray, Angiographic
- JFBTable, Physical Therapy, Multi Function
- IZZTable, Radiographic, Non-Tilting, Powered
- IXRTable, Radiographic, Tilting
- IOLTreadmill, Powered
- EXYUroflowmeter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain