ClearanceBrief
Panels › Gastroenterology, Urology › Product code FEO · Class 2

Lithotriptor, Ultrasonic

Regulation 876.4480

0510(k)s in 12 months (14 all time)
5recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in FEO

Company510(k)sRecalls
Olympus Corporation of the Americas07
E.M.S Electro Medical Systems S.A50
Cybersonics, Inc.20
Fibra Sonics, Inc.20
KARL STORZ Endoscopy-America, Inc.20
Cabot Medical Corp.10
Olympus Corp.10
Richard Wolf Medical Instruments Corp.10
Decided510(k)Device and applicantCode
Oct 23, 2023K230893Swiss LthoClast Trilogy
E.M.S Electro Medical Systems S.A, CH
FEO
Oct 9, 2018K182490Swiss LithoClast Trilogy
E.M.S Electro Medical Systems S.A, CH
FEO
Aug 30, 2018K181997Swiss LithoClast Trilogy
E.M.S Electro Medical Systems S.A, CH
FEO
Jun 20, 2018K181364Swiss LithoClast Trilogy
E.M.S Electro Medical Systems S.A, CH
FEO
Jan 10, 2018K173234Swiss LithoClast Trilogy
E.M.S Electro Medical Systems S.A, CH
FEO
Aug 21, 2017K171024ShockPulse-SE Lithotripsy System
Cybersonics, Inc.
FEO
Nov 13, 2014K142428Shock Pulse-SE Lithotripsy System CYBERWAND II
Cybersonics, Inc.
FEO
Nov 22, 1999K993046FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
Fibra Sonics, Inc.
FEO
Jun 22, 1998K973251KSEA CALCUSON
KARL STORZ Endoscopy-America, Inc.
FEO
Dec 7, 1992K920235ULTRASOUND GENERATOR MODLE 2270
Richard Wolf Medical Instruments Corp.
FEO
Nov 30, 1987K873367OLYMPUS LUS ULTRASONIC LITHOTRIPTER
Olympus Corp.
FEO
Mar 5, 1985K850298ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
Cabot Medical Corp.
FEO
Dec 11, 1984K843101KARL STORZ 27086KC ULTRASONIC LITHOTRI
KARL STORZ Endoscopy-America, Inc.
FEO
Dec 11, 1984K842024ULTRASONIC LITHOTRIPTOR 300A
Fibra Sonics, Inc.
FEO

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