510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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E.M.S. - Electro Medical Systems SA

Southlake, TX, US

E.M.S. ELECTRO MEDICAL SYSTEMS S.A. appears in FDA device records in Southlake, TX. FDA records list 41 510(k) clearances between and , 2 PMA records and 3 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
41
PMA records
2
Recall records
5
Registered establishments
3

FDA records under these names

2 names

FDA records resolved to E.M.S. - Electro Medical Systems SA carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Electro Medical Systems (Ems Sa)510(k), PMA, recall
  • Electro Medical Systems, Inc.registration, 510(k), enforcement report, recall

510(k) clearance history

FDA records hold 41 510(k) clearances for E.M.S. - Electro Medical Systems SA between 1990 and 2026. The busiest year on record is 2018, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for E.M.S. - Electro Medical Systems SA, by decision year
YearClearances
19902
19952
19961
19972
19992
20001
20011
20022
20051
20072
20092
20102
20111
20133
20142
20151
20161
20172
20184
20193
20221
20231
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253254GBT Machine Airflow Prophylaxis MasterELCSubstantially Equivalent
K243279DOLORCLAST Focused Shock WavesPZLSubstantially Equivalent
K230893Swiss LthoClast TrilogyFEOSubstantially Equivalent
K220538DolorClast RadialISASubstantially Equivalent
K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneELCSubstantially Equivalent
K191079Piezon Built-in Kit, Piezon Built-in Kit LEDELCSubstantially Equivalent
K191124Swiss LithoClast TrilogyFFKSubstantially Equivalent
K182490Swiss LithoClast TrilogyFEOSubstantially Equivalent
K181997Swiss LithoClast TrilogyFEOSubstantially Equivalent
K181364Swiss LithoClast TrilogyFEOSubstantially Equivalent
K173234Swiss LithoClast TrilogyFEOSubstantially Equivalent
K171174PERIO-FLOW nozzleEFBSubstantially Equivalent
K171189AIR-FLOW PLUS Prophylaxis powderEJRSubstantially Equivalent
K151912AIR-FLOW handy 3.0 PLUSEFBSubstantially Equivalent
K140990EMS PIEZON 707 BIK AND PIEZON 707 BIK LEDELCSubstantially Equivalent
K132478AIR-FLOW HANDY 3.0EFBSubstantially Equivalent
K132480AIR-FLOW HANDY 3.0 PERIOEFBSubstantially Equivalent
K132445PIEZON 250ELCSubstantially Equivalent
K132443PIEZON 150ELCSubstantially Equivalent
K123038SWISS LITHOBREAKERFFKSubstantially Equivalent
K110173EMS AIR-FLOW MASTER PIEZONELCSubstantially Equivalent
K093723EMS MINIMASTER LEDELCSubstantially Equivalent
K093000EMS PIEZON MASTER 700ELCSubstantially Equivalent
K092289EMS AIR-FLOW HANDY PERIOEFBSubstantially Equivalent
K082791EMS AIR-FLOW MASTEREFBSubstantially Equivalent
K072146EMS PIEZON MASTER SURGERYDZISubstantially Equivalent
K071722DEEP BLUEEBZSubstantially Equivalent
K050710MINIMASTER ULTRASONIC SCALERELCSubstantially Equivalent
K022328EMS PIEZON MASTER 600ELCSubstantially Equivalent
K022119EMS AIR-FLOW HANDY 2 DENTAL HANDPIECEEFBSubstantially Equivalent
K012445EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)FFKSubstantially Equivalent
K002484EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVALJDXSubstantially Equivalent
K991857AIRFLOW HANDYEFBSubstantially Equivalent
K992251SWISS LITHOCLAST MULTIPURPOSE PROBEFFKSubstantially Equivalent
K965203RADX SYSTEMEHDSubstantially Equivalent
K963285EMS SWISS LITHOCLAST LITHOTRIPTERFFKSubstantially Equivalent
K964111LITHOVAC SUCTION/ASPIRATION PROBEKQTSubstantially Equivalent
K953026MINIPIEZONELCSubstantially Equivalent
K951531SWISS LITHOCLAST LITHOTRIPTERFFKSubstantially Equivalent
K896749PIEZON MASTER 400ELCSubstantially Equivalent
K900709AIR FLOW SIIELCSubstantially Equivalent

Registered establishments

FDA registered establishments for E.M.S. - Electro Medical Systems SA, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30040964293004096429E.M.S. ELECTRO MEDICAL SYSTEMS S.A.RTE DE CHAMP-COLIN 2, NYON Vaud 1260 CH2026and 2 more, listed in full below
80309873002806910E.M.S. ELECTRO MEDICAL SYSTEMS S.A.31 CH. DE LA VUARPILLIERE, NYON Vaud CH-1260 CH2026and 4 more, listed in full below
16485643000205943ELECTRO MEDICAL SYSTEMS, L.L.C.2150E Continental Boulevard, Southlake, TX 76092 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1688-2024Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONEReceived complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).Class IIOpen, Classified
Z-1687-2024Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONEReceived complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).Class IIOpen, Classified
Z-1686-2024Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONEReceived complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).Class IIOpen, Classified
Z-0684-2007Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .Handpiece may become dislodged causing cable damage and possible electric shock.Terminated
Z-0078-04LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MAFailure of foot pedal to activate deviceTerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain