Biodan Medical Systems, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K932153THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROMESeptember 7, 1993
K930261RTM REHABILITATION TREADMILL, MODEL #945-200May 26, 1993
K930262TREATMENT TABLE, MODEL #825-100March 29, 1993
K930259TRACTION TABLE MODEL #825-200March 24, 1993
K926083NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPESFebruary 12, 1993
K926082CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATTDecember 30, 1992
K922591UROLOGICAL C-ARM TABLE, MODEL #056-450November 27, 1992
K922604DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLEOctober 20, 1992
K922605TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603October 20, 1992
K923350CLOSED CHAIN ATTACHMENT, MODEL #820-520July 23, 1992
K922772TWO POSITION ROLL-UP BACK ATTACHMENT CHAIRJuly 13, 1992
K922606MULTI JOINT WEIGHT SYSTEM MODEL #940-100June 19, 1992
K922603TOTAL WORK INTEGRATOR, MODEL #940-110June 19, 1992
K922602CABLE COLUMN WEIGHT SYSTEM MODEL #940-200June 19, 1992
K922092SINGLE CHAIR INTEGRAL BACK ATTACHMENTMay 26, 1992
K921501DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004May 15, 1992
K900770HOME URODATA SYSTEM(TM)June 8, 1990
K840088BIODEX ACT-O-KIT TSH-RIA-May 7, 1984
K832896LEGIONELLA INDIRECT FLUORESCENT ANTIBODOctober 14, 1983
K822066LEGIONELLA PNEUMOPHILASeptember 21, 1982