Lithotriptor, Ultrasonic

Product Code: FEO

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: 876.4480


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as FEO

1790Lithotriptor, UltrasonicElectrohydraulic Lithotriptor.

Total Product Life Cycle (TPLC) Devices

1790Lithotriptor, UltrasonicElectrohydraulic Lithotriptor.

Pre-market Notifications for FEO

K182490Swiss LithoClast TrilogyEMS Electro Medical Systems SA
K181997Swiss LithoClast TrilogyEMS Electro Medical Systems SA
K181364Swiss LithoClast TrilogyEMS Electro Medical Systems SA
K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems SA
K171024ShockPulse-SE Lithotripsy SystemCybersonics, Inc.
K142428Shock Pulse-SE Lithotripsy System CYBERWAND IICYBERSONICS, INC.
K993046FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000FIBRA SONICS, INC.
K973251KSEA CALCUSONKARL STORZ ENDOSCOPY-AMERICA, INC.
K873367OLYMPUS LUS ULTRASONIC LITHOTRIPTEROLYMPUS CORP.
K850298ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEMCABOT MEDICAL CORP.
K843101KARL STORZ 27086KC ULTRASONIC LITHOTRIKARL STORZ ENDOSCOPY-AMERICA, INC.
K842024ULTRASONIC LITHOTRIPTOR 300AFIBRA SONICS, INC.

Global Unique Device Identification Database

00821925039445Lithotriptor, ultrasonic
00855279005160Lithotriptor, Ultrasonic
00855279005153Lithotriptor, Ultrasonic
00855279005139Lithotriptor, Ultrasonic
10855279005129Lithotriptor, Ultrasonic
00855279005108Lithotriptor, Ultrasonic
00855279005092Lithotriptor, Ultrasonic
00855279005061Lithotriptor, Ultrasonic
00855279005054Lithotriptor, Ultrasonic
00855279005030Lithotriptor, Ultrasonic
00855279005023Lithotriptor, Ultrasonic
00855279005016Lithotriptor, Ultrasonic
07613353164027Lithotriptor, Ultrasonic
07613353164010Lithotriptor, Ultrasonic
07613353162702Lithotriptor, Ultrasonic

Maude Adverse Events

SHOCKPULSE PROBE SINGLE USE, 1.50MM 3/BXGYRUS ACMI INC2020-03-26
SHOCKPULSE PROBE SINGLE USE, 1.50MM 3/BXGYRUS ACMI INC2020-03-26
SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,GYRUS ACMI INC2020-03-12
SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BXGYRUS ACMI INC2020-03-11
SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,GYRUS ACMI INC2020-02-11
SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BXGYRUS ACMI INC2019-11-14
SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BXGYRUS ACMI INC2019-11-13
SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSABGYRUS ACMI INC2019-10-17
CYBERWAND USL ULTRASONIC LITHOTRIPSY SYSTEMOLYMPUS AMERICA INC2019-09-25
SHOCKPULSE LITHOTRIPSY FOOTSWITCHGYRUS ACMI INC2019-09-05
SHOCKPULSE LITHOTRIPSY TRANSDUCERCYBERSONICS, INC.2019-08-08
SHOCKPULSE LITHOTRIPSY GENERATORCYBERSONICS INC2019-07-18
SHOCKPULSE LITHOTRIPSY PROBE, SINGLE USE 3.40 MM (3/BOX)CYBERSONICS, INC.2019-06-04
PROBE,STERILE, ULTRASONIC OSCILLATINGKARL STORZ SE & CO. KG2019-04-22
ULTRASONIC LITHOTRIPSY PROBE WITH OSCILLATING BURR TIPKARL STORXZ SE & KG2019-03-28
SHOCKPULSE SE LITHOTRIPSY PROBE, STERILE, SINGLE USE, 3.76MMCYBERSONICS INC.2018-11-27
OSCILLATING ULTRASONIC PROBEKARL STORZ SE & CO. KG2018-11-21
STORZ ULTRASONIC OSCILLATING BURR TIPKARL STORZ ENDOSCOPY - ANIMAS, INC.2018-11-14
STORZ ULTRASONIC OSCILLATING BURR TIPKARL STORZ ENDOSCOPY - AMERICA, INC.2018-11-14
KARL STORZ ULTRASONIC OSCILLATING BURR TIPKARL STORZ ENDOSCOPY - AMERICA, INC.2018-11-09
SHOCKPULSE SE LITHOTRIPSY PROBE, REUSABLE, 3.40MMCYBERSONICS INC.2018-10-29
SHOCKPULSE SE LITHOTRIPSY PROBE, REUSABLE, 3.40MMCYBERSONICS INC.2018-10-29
SHOCKPULSE SE LITHOTRIPSY PROBE, REUSABLE, 3.76MMCYBERSONICS INC.2018-10-29
SHOCKPULSE SE LITHOTRIPSY PROBE, STERILE SINGLE USE, 3.76MM (3/BOX)CYBERSONICS INC.2018-09-14
??SHOCKPUL SE?LITHOTRIPSY?PROBE, STERILE?SINGLE?USE,?3.76MM?(3/BOX)CYBERSONICS INC.2018-06-04
OLYMPUS CYBERWAND ULTRASONIC LITHOTRIPTER PROBEOLYMPUS2018-03-08
LITHOTRIPSY PROBE, STERILE SINGLE USE SHOCKPULSE-SECYBERSONICS INC2017-09-27
SHOCKPULSE LITHOTRIPSY PROBE 3.40CYBERSONICS INC.2017-09-26
AUTOCLAVABLE TRANSDUCER FOR LUS-2OLYMPUS MEDICAL SYSTEMS CORP.2017-06-22
PROBEOLYMPUS MEDICAL SYSTEMS COOPERATION2017-01-22
PROBEOLYMPUS MEDICAL SYSTEMS COOPERATION2017-01-22
PROBEOLYMPUS MEDICAL SYSTEMS COOPERATION2017-01-22
PROBEOLYMPUS MEDICAL SYSTEMS COOPERATION2017-01-19
PROBEOLYMPUS MEDICAL SYSTEMS COOPERATION2017-01-19
CYBERWANDOLYMPUS2016-10-31
OLYMPUS SHOCKPULSE SEOLYMPUS SURGICAL2016-07-01
ULTRASONIC PROBEKARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY2015-11-06
ULTRASONIC PROBEKARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY2015-11-06
AUTOCLAVABLE TRANSDUCER "MAJ-1215", FOR LUS-2OLYMPUS MEDICAL SYSTEM CORPORATION2015-07-17
LITHOTRIPTOR VOLYMPUS2015-07-02
OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR VOLYMPUS MEDICAL SYSTEMS CORPORATION2015-02-27
OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR VOLYMPUS MEDICAL SYSTEMS CORPORATION2015-01-07
OP-TELESCOPE, 10 MM, 6 DEGREE, 5.5 MM CHANNEL, OCULAOLYMPUS WINTER & IBE GMBH2014-11-20
ULTRASONIC PROBEKARL STORZ GMBH & CO.2014-11-03
OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR VOLYMPUS MEDICAL SYSTEMS CORPORATION2014-10-08
OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR VOLYMPUS MEDICAL SYSTEMS CORPORATION2014-08-07
ULTRASONIC PROBEKARL STORZ GMBH & CO.2014-06-20
OLYMPUS SINGL USE MECHANICAL LITHOTRIPTOR VOLYMPUS AMERICA, INC.2014-06-20
OLYMPUS ULTRASONIC LITHOTRIPTOR PROBEOLYMPUS MEDICAL SYS CORP2014-05-22
OLYMPUS ULTRASONIC LITHOTRIPTOR PROBEOLYMPUS MEDICAL SYSTEM CORPORATION2014-05-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.