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Electro Medical Systems SA

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
11
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1686-2024Class IIBrand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software VeMarch 13, 2024
Z-1687-2024Class IIBrand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software VersionMarch 13, 2024
Z-1688-2024Class IIBrand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software VersiMarch 13, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K022328EMS PIEZON MASTER 600August 13, 2002
K022119EMS AIR-FLOW HANDY 2 DENTAL HANDPIECEJuly 25, 2002
K012445EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)August 24, 2001
K002484EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVALOctober 4, 2000
K991857AIRFLOW HANDYOctober 7, 1999
K992251SWISS LITHOCLAST MULTIPURPOSE PROBEJuly 27, 1999
K965203RADX SYSTEMMarch 17, 1997
K963285EMS SWISS LITHOCLAST LITHOTRIPTERFebruary 13, 1997
K964111LITHOVAC SUCTION/ASPIRATION PROBEDecember 16, 1996
K953026MINIPIEZONAugust 28, 1995
K951531SWISS LITHOCLAST LITHOTRIPTERAugust 24, 1995