# Electro Medical Systems SA

- Location (FDA's records): North Attleboro, MA
- FDA decisions: 11 (1995–2002): 11 510(k) clearances
- Names in FDA's records: Electro Medical Systems SA (9); Electro Medical Systems, Inc. (2)
- Product codes: FFK (4), EFB (2), ELC (2), KQT (1), JDX (1), EHD (1)
- Predicates its devices cite: 14 (6 its own); citations of its devices by later devices: 38 (6 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Electro Medical Systems (Ems Sa): 2 (https://510kreport.com/company/electro-medical-systems-ems)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Candela Corp.: 1 (https://510kreport.com/company/candela)
- Candela Laser Corp.: 1 (https://510kreport.com/company/candela-laser)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Kavo America: 1 (https://510kreport.com/company/kavo-america)
- (Ems Sa) Electro Medical Systems: 1 (https://510kreport.com/company/ems-sa-electro-medical-systems)

## Firms that cite its devices most
- E.M.S Electro Medical Systems S.A: 6 (https://510kreport.com/company/ems-electro-medical-systems-s-a)
- Sirona Dental Systems GmbH: 3 (https://510kreport.com/company/sirona-dental-systems)
- Elmed USA: 2 (https://510kreport.com/company/elmed-usa)
- The Laryngeal Mask Co., Ltd.: 2 (https://510kreport.com/company/laryngeal-mask)
- (Ems Sa) Electro Medical Systems: 2 (https://510kreport.com/company/ems-sa-electro-medical-systems)
- Medispec, Ltd.: 2 (https://510kreport.com/company/medispec)
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Medical Device Consultants, Inc.: 2 (https://510kreport.com/company/medical-device-consultants)

## Its most-cited devices
- K963285: Ems Swiss Lithoclast Lithotripter (1997), cited by 8
- K951531: Swiss Lithoclast Lithotripter (1995), cited by 8
- K953026: Minipiezon (1995), cited by 6
- K022119: Ems Air-Flow Handy 2 Dental Handpiece (2002), cited by 5
- K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) (2001), cited by 5
- K022328: Ems Piezon Master 600 (2002), cited by 5

## Recent decisions
- K022328: Ems Piezon Master 600 (Aug 13, 2002)
- K022119: Ems Air-Flow Handy 2 Dental Handpiece (Jul 25, 2002)
- K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) (Aug 24, 2001)
- K002484: Ems Swiss Orthoclast Chisels for Non-Cemented Prosthesis Removal (Oct 4, 2000)
- K991857: Airflow Handy (Oct 7, 1999)
- K992251: Swiss Lithoclast Multipurpose Probe (Jul 27, 1999)
- K965203: Radx System (Mar 17, 1997)
- K963285: Ems Swiss Lithoclast Lithotripter (Feb 13, 1997)

Source page: https://510kreport.com/company/electro-medical-systems