Lithotriptor, Extracorporeal Shock-wave, Urological

Product Code: LNS

Gastroenterology/Urology Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 876.5990


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as LNS

1990Lithotriptor, Extracorporeal Shock-wave, UrologicalExtracorporeal Shock Wave Lithotripter.

Total Product Life Cycle (TPLC) Devices

1990Lithotriptor, Extracorporeal Shock-wave, UrologicalExtracorporeal Shock Wave Lithotripter.

FDA Consensus Standards

Lithotriptor, Extracorporeal Shock-Wave, Urological [37690]21 CFR §876.5990 🔎
Lithotriptor, Extracorporeal Shock-Wave, Urological [21931]21 CFR §876.5990 🔎

Pre-market Approvals for LNS

P880011TECHNOMED INTERNATIONAL SONOLITH 2000EDAP INTERNATIONAL CORP.
P840008DORNIER LITHOTRIPTER, MODEL HM3Dornier MedTech America, Inc.
P950043ECONOLITH(TM) LITHOTRIPTERMEDISPEC, LTD.
P870015TRANSPORTABLE MODEL STS-T LITHOTRIPTERMEDSTONE INTL., INC.

Pre-market Notifications for LNS

K201074Delta III LithotripterDornier MedTech America, Inc.
K172084Delta III LithotripterDornier MedTech America, Inc.
K170122Delta III LithotripterDornier MedTech America
K151298Gemini XXP-HPDornier MedTech America
K142561LM-9300 ELMA LithotripterLITE-MED INC.
K132672EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERDORNIER MEDTECH AMERICA
K131817EXTRACORPOREAL SHOCK WAVE LITHOTRIPTEROSMUNDA MEDICAL DEVICE CONSULTING CO., LTD.
K131721EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1COMED MEDICAL SYSTEMS CO., LTD
K130729EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERDORNIER MEDTECH SYSTEMS
K121656GEMINI LITHOTRIPTERDORNIER MEDTECH AMERICA, INC.
K120769MODULTH SLKKARL STORZ ENDOSCOPY-AMERICA, INC.
K111947DUET MAGNADIREX SYSTEMS CORP.
K111808SONOLITH I-MOVEEDAP TMS FRANCE
K103217LITE-MED LM-9200 ELMALITE-MED INC
K101482EM-9000ELITE MEDICAL INC

Global Unique Device Identification Database

00810000980376Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980369Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980352Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980345Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980338Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980321Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980314Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980307Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980291Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980284Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980277Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980260Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980253Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980246Lithotriptor, Extracorporeal Shock-Wave,Urological
00810000980239Lithotriptor, Extracorporeal Shock-Wave,Urological

Maude Adverse Events

COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2020-03-13
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2020-03-13
COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2020-03-12
COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2020-03-10
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2020-02-28
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2020-02-03
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2020-02-03
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2020-01-31
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2020-01-17
COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2020-01-08
MODULITH SLX-F2 180MM (25K) LITHOTRIPTORSTORZ MEDICAL AG2019-11-19
COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-11-18
COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-11-15
COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-11-13
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-10-31
MODULITH SLX-F2STORZ MEDICAL AG2019-10-29
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-10-16
COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-10-16
MODULITH SLX-F2 180MM (19K) LITHOTRIPTORSTORZ MEDICAL AG2019-10-07
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-10-02
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-09-30
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-09-19
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-09-12
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-09-06
LITHOTRON LITHOTRIPTERHEALTHTRONICS, INC.2019-09-05
MODULITH SLX-F2 180MM (25K) LITHOTRIPTORSTORZ MEDICAL AG2019-09-04
MODULITH SLX-F2 180MM (25K) LITHOTRIPTORSTORZ MEDICAL AG2019-09-04
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-08-23
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-08-20
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-08-20
DORNIER COMPACT SIGMADORNIER MEDTECH SYSTEMS GMBH2019-08-12
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-08-09
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-08-08
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-07-31
DORNIER COMPACT SIGMADORNIER MEDTECH SYSTEMS GMBH2019-07-30
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-07-26
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-07-26
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-07-24
DORNIER COMPACT SIGMADORNIER MEDTECH SYSTEMS GMBH2019-07-24
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-07-24
LITHOTRON LITHOTRIPTERHEALTHTRONICS, INC.2019-07-23
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-07-23
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-07-15
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-07-15
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-07-03
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-06-17
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-05-28
DORNIER DELTA IIIDORNIER MEDTECH SYSTEMS GMBH2019-05-22
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-05-21
DORNIER COMPACT DELTA IIDORNIER MEDTECH SYSTEMS GMBH2019-05-20
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