Medical Device Manufacturer · IL , Israel

Biodan Medical Systems, Ltd.

20 submissions · 20 cleared · Since 1982

20

Total

20

Cleared

0

Denied

Biodan Medical Systems, Ltd. — FDA 510(k) Submissions

Biodan Medical Systems, Ltd. has submitted 20 FDA 510(k) premarket notifications since 1982, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Isokinetic Testing And Evaluation, Exerciser, Measuring, System, Imaging, Pulsed Echo, Ultrasonic, Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, System, X-ray, Angiographic . Use the specialty filter in the sidebar to narrow results.

20 devices

1–20 of 20

THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME

K932153 · IZD Probe, Uptake, Nuclear · Radiology

RTM REHABILITATION TREADMILL, MODEL #945-200

K930261 · IOL Treadmill, Powered · Physical Medicine

TREATMENT TABLE, MODEL #825-100

K930262 · INO Chair, Positioning, Electric · Physical Medicine

TRACTION TABLE MODEL #825-200

K930259 · JFB Table, Physical Therapy,... · Physical Medicine

NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES

K926083 · IYX Camera, Scintillation... · Radiology

CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT

K926082 · IZI System, X-ray, Angiographic · Radiology

UROLOGICAL C-ARM TABLE, MODEL #056-450

K922591 · IXR Table, Radiographic, Tilting · Radiology

DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE

K922604 · IYO System, Imaging, Pulsed... · Radiology

TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603

K922605 · IYO System, Imaging, Pulsed... · Radiology

CLOSED CHAIN ATTACHMENT, MODEL #820-520

K923350 · IKK System, Isokinetic... · Physical Medicine

TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR

K922772 · IKK System, Isokinetic... · Physical Medicine

CABLE COLUMN WEIGHT SYSTEM MODEL #940-200

K922602 · ISD Exerciser, Measuring · Physical Medicine

TOTAL WORK INTEGRATOR, MODEL #940-110

K922603 · ISD Exerciser, Measuring · Physical Medicine

MULTI JOINT WEIGHT SYSTEM MODEL #940-100

K922606 · ISD Exerciser, Measuring · Physical Medicine

SINGLE CHAIR INTEGRAL BACK ATTACHMENT

K922092 · IKK System, Isokinetic... · Physical Medicine

DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004

K921501 · IZZ Table, Radiographic,... · Radiology

HOME URODATA SYSTEM(TM)

K900770 · EXY Uroflowmeter · Gastroenterology & Urology

BIODEX ACT-O-KIT TSH-RIA-

K840088 · JLW Radioimmunoassay,... · Chemistry

LEGIONELLA INDIRECT FLUORESCENT ANTIBOD

K832896 · LHL Reagents, Antibody,... · Immunology

LEGIONELLA PNEUMOPHILA

K822066 · LHL Reagents, Antibody,... · Microbiology