Company ยท US
Biodan Medical Systems, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1993. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | 3 |
| ISD | Exerciser, Measuring | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 |
| EXY | Uroflowmeter | 1 |
| INO | Chair, Positioning, Electric | 1 |
| IOL | Treadmill, Powered | 1 |
| IXR | Table, Radiographic, Tilting | 1 |
| IYX | Camera, Scintillation (Gamma) | 1 |
| IZD | Probe, Uptake, Nuclear | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 |
| JFB | Table, Physical Therapy, Multi Function | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 1993 | K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME Biodan Medical Systems, Ltd. | IZD |
| May 26, 1993 | K930261 | RTM REHABILITATION TREADMILL, MODEL #945-200 Biodan Medical Systems, Ltd. | IOL |
| Mar 29, 1993 | K930262 | TREATMENT TABLE, MODEL #825-100 Biodan Medical Systems, Ltd. | INO |
| Mar 24, 1993 | K930259 | TRACTION TABLE MODEL #825-200 Biodan Medical Systems, Ltd. | JFB |
| Feb 12, 1993 | K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES Biodan Medical Systems, Ltd. | IYX |
| Dec 30, 1992 | K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT Biodan Medical Systems, Ltd. | IZI |
| Nov 27, 1992 | K922591 | UROLOGICAL C-ARM TABLE, MODEL #056-450 Biodan Medical Systems, Ltd. | IXR |
| Oct 20, 1992 | K922605 | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 Biodan Medical Systems, Ltd. | IYO |
| Oct 20, 1992 | K922604 | DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE Biodan Medical Systems, Ltd. | IYO |
| Jul 23, 1992 | K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 Biodan Medical Systems, Ltd. | IKK |
| Jul 13, 1992 | K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR Biodan Medical Systems, Ltd. | IKK |
| Jun 19, 1992 | K922606 | MULTI JOINT WEIGHT SYSTEM MODEL #940-100 Biodan Medical Systems, Ltd. | ISD |
| Jun 19, 1992 | K922603 | TOTAL WORK INTEGRATOR, MODEL #940-110 Biodan Medical Systems, Ltd. | ISD |
| Jun 19, 1992 | K922602 | CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 Biodan Medical Systems, Ltd. | ISD |
| May 26, 1992 | K922092 | SINGLE CHAIR INTEGRAL BACK ATTACHMENT Biodan Medical Systems, Ltd. | IKK |
| May 15, 1992 | K921501 | DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 Biodan Medical Systems, Ltd. | IZZ |
| Jun 8, 1990 | K900770 | HOME URODATA SYSTEM(TM) Biodan Medical Systems, Ltd., IL | EXY |
| May 7, 1984 | K840088 | BIODEX ACT-O-KIT TSH-RIA- Biodan Medical Systems, Ltd., IL | JLW |
| Oct 14, 1983 | K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD Biodan Medical Systems, Ltd. | LHL |
| Sep 21, 1982 | K822066 | LEGIONELLA PNEUMOPHILA Biodan Medical Systems, Ltd., IL | LHL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||