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Gastroenterology, Urology

2,721 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
LITHOSTAR CHANGES TO SETTING AND MONITOR (P870018/S007)Siemens Corp.1992-10-05
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S013)Medstone Intl., Inc.1992-08-13
LITHOSTAR CHANGES TO SETTING AND MONITOR (P870018/S006)Siemens Corp.1992-08-11
MODEL MFL5000 CHANGE TO ELECTRODE PACKAGE INSERT (P840008/S041)Dornier Medtech America, Inc.1992-08-06
DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER (P840008/S037)Dornier Medtech America, Inc.1992-07-29
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S017)Medstone Intl., Inc.1992-07-27
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S016)Medstone Intl., Inc.1992-07-13
TPS 102 PHOTOCEPTOR ACTIVATION CHAMBER (P860003/S021)Therakos Development Limited1992-06-19
TPS 101 PHOTOPHERESIS BLOOD TUBING SET (P860003/S022)Therakos Development Limited1992-06-19
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S015)Medstone Intl., Inc.1992-05-19
THERASONIC LITHOTRIPSY TREATMENT SYSTEM (P890066/S004)Focus Surgery, Inc.1992-03-26
THERASONIC LITHOTRIPSY TREATMENT SYSTEM (P890066/S001)Focus Surgery, Inc.1992-03-01
TECHNOMED INTERNATIONAL SONOLITH 3000 (LITHORAY)TM (P880011/S007)Edap International Corp.1992-02-10
LITHOSTAR (P870018/S005)Siemens Corp.1992-02-05
DORNIER MODELS HM3 & HM4 LITHOTRIPTER (P840008/S034)Dornier Medtech America, Inc.1992-01-02
DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER (P840008/S035)Dornier Medtech America, Inc.1992-01-02
DORNIER LITHOTRIPTER MODEL MFL 5000 (P840008/S031)Dornier Medtech America, Inc.1991-12-20
THERASONIC LITHOTRIPSY TREATMENT SYSTEM (P890066)Focus Surgery, Inc.1991-12-20
EDAP LT.01 SHOCK WAVE LITHOTRIPTER (P880042)Edap International Corp.1991-12-12
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S012)Medstone Intl., Inc.1991-11-07
DORNIER HM4 MOBILE LITHOTRIPTER (P840008/S032)Dornier Medtech America, Inc.1991-11-06
DORNIER MPL9000 LITHOTRIPTER (P840008/S033)Dornier Medtech America, Inc.1991-10-04
RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013)Richard Wolf Medical Instruments Corp.1991-09-09
DORNIER MPL 9000 - MOBILE LITHOTRIPTER (P840008/S028)Dornier Medtech America, Inc.1991-08-13
DORNIER MPL 9000 - RENAL APPLICATION (P840008/S026)Dornier Medtech America, Inc.1991-08-12
DORNIER LITHOTRIPTER MODELS HM3 AND HM4 (P840008/S030)Dornier Medtech America, Inc.1991-08-06
DORNIER LITHOTRIPTER MODELS HM3 AND HM4 (P840008/S029)Dornier Medtech America, Inc.1991-07-25
DORNIER LITHOTRIPTER, MODEL MFL5000 (P840008/S024)Dornier Medtech America, Inc.1991-07-03
DORNIER LITHOTRIPTER, MODEL MFL5000 (P840008/S025)Dornier Medtech America, Inc.1991-07-03
LITHOSTAR (P870018/S004)Siemens Corp.1991-03-18
UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING (P860003/S019)Therakos Development Limited1991-03-11
UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING (P860003/S018)Therakos Development Limited1991-02-13
MEDSTONE 1050 EXTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S009)Medstone Intl., Inc.1991-02-06
PROSORBA(TM) COLUMN (P850020/S003)Fresenius Hemocare, Inc.1991-02-06
DORNIER MPL 9000 - RENAL APPLICATION (P840008/S027)Dornier Medtech America, Inc.1991-01-18
MEDSTONE 1050 EXTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S010)Medstone Intl., Inc.1990-12-24
TECHNOMED INTERNATIONAL SONOLITH 2000 (P880011/S004)Edap International Corp.1990-12-24
LITHOSTAR (P870018/S003)Siemens Corp.1990-12-24
UVAR PHOTOPHERESIS SYSTEM (P860003/S017)Therakos Development Limited1990-12-13
ANGELCHIK ANTI-REFLUX PROSTHESIS (P790006/S005)Allergan, Inc.1990-10-25
HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE (P870011)Towers Perrin1990-09-06
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S018)Dornier Medtech America, Inc.1990-07-16
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S023)Dornier Medtech America, Inc.1990-05-03
UVAR PHOTOPHERESIS SYSTEM (P860003/S012)Therakos Development Limited1990-02-23
UVAR PHOTOPHERESIS SYSTEM (P860003/S014)Therakos Development Limited1990-01-26
TECHNOMED INTERNATIONAL SONOLITH 2000 (P880011/S002)Edap International Corp.1989-12-27
UVAR PHOTOPHERESIS SYSTEM (P860003/S013)Therakos Development Limited1989-12-22
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S021)Dornier Medtech America, Inc.1989-10-19
MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S008)Medstone Intl., Inc.1989-09-13
LITHOSTAR (P870018/S002)Siemens Corp.1989-08-08
TECHNOMED INTERNATIONAL SONOLITH 2000 (P880011/S001)Edap International Corp.1989-06-27
TECHNOMED INTERNATIONAL SONOLITH 2000 (P880011)Edap International Corp.1989-06-23
LITHOSTAR (P870018/S001)Siemens Corp.1989-04-18
UVAR PHOTOPHERESIS SYSTEM (P860003/S011)Therakos Development Limited1989-04-12
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S016)Dornier Medtech America, Inc.1989-01-19
UVAR PHOTOPHERESIS SYSTEM (P860003/S006)Therakos Development Limited1988-12-29
UVAR PHOTOPHERESIS SYSTEM (P860003/S010)Therakos Development Limited1988-12-28
MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S003)Medstone Intl., Inc.1988-10-26
UVAR PHOTOPHERESIS SYSTEM (P860003/S009)Therakos Development Limited1988-10-07
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S019)Dornier Medtech America, Inc.1988-09-30
LITHOSTAR (P870018)Siemens Corp.1988-09-30
UVAR PHOTOPHERESIS SYSTEM (P860003/S008)Therakos Development Limited1988-06-30
MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S001)Medstone Intl., Inc.1988-06-28
UVAR PHOTOPHERESIS SYSTEM (P860003/S007)Therakos Development Limited1988-06-17
MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S002)Medstone Intl., Inc.1988-06-14
MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015)Medstone Intl., Inc.1988-04-15
UVAR PHOTOPHERESIS SYSTEM (P860003/S005)Therakos Development Limited1988-02-10
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S015)Dornier Medtech America, Inc.1988-02-03
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S014)Dornier Medtech America, Inc.1987-12-31
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S012)Dornier Medtech America, Inc.1987-12-29
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S013)Dornier Medtech America, Inc.1987-12-29
PROSORBA(TM) COLUMN (P850020)Fresenius Hemocare, Inc.1987-12-23
UVAR PHOTOPHERESIS SYSTEM (P860003/S004)Therakos Development Limited1987-11-06
UVAR PHOTOPHERESIS SYSTEM (P860003/S003)Therakos Development Limited1987-11-06
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S010)Dornier Medtech America, Inc.1987-09-17
UVAR PHOTOPHERESIS SYSTEM (P860003/S002)Therakos Development Limited1987-09-09
PLASMA SEPARATION SYSTEM (P820032/S005)Fenwal, Inc.1987-08-25
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S009)Dornier Medtech America, Inc.1987-06-11
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S011)Dornier Medtech America, Inc.1987-06-09
UVAR PHOTOPHERESIS SYSTEM (P860003/S001)Therakos Development Limited1987-05-15
REPRO-MED - THD (P820034/S002)Repro-Med Systems, Inc.1987-05-12
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S006)Dornier Medtech America, Inc.1987-05-06
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S008)Dornier Medtech America, Inc.1987-05-06
UVAR PHOTOPHERESIS SYSTEM (P860003)Therakos Development Limited1987-04-08
GARREN GASTRIC BUBBLE (P840025/S011)American Edwards Laboratories1987-03-17
THERAPEUTIC APHERESIS SYSTEM (P850092)Millipore Corp.1986-11-18
GARREN GASTRIC BUBBLE (P840025/S008)American Edwards Laboratories1986-10-16
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S007)Dornier Medtech America, Inc.1986-09-30
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S005)Dornier Medtech America, Inc.1986-08-27
GARREN GASTRIC BUBBLE (P840025/S006)American Edwards Laboratories1986-07-25
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S004)Dornier Medtech America, Inc.1986-06-20
GAMBRO FIBER PLASMAFILTER (P830063)Vantive US Healthcare, LLC1986-05-27
GARREN{TM}-EDWARDS GASTRIC BUBBLE (P840025/S005)American Edwards Laboratories1986-05-12
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S003)Dornier Medtech America, Inc.1986-04-14
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S001)Dornier Medtech America, Inc.1986-04-14
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S002)Dornier Medtech America, Inc.1986-02-05
GARREN GASTRIC BUBBLE (P840025/S003)American Edwards Laboratories1986-01-23
GARREN GASTRIC BUBBLE (P840025/S002)American Edwards Laboratories1986-01-23
GARREN GASTRIC BUBBLE (P840025/S004)American Edwards Laboratories1986-01-23
PLASMAFLO AP-05H ASAHI PLASMA SEPARATOR (P820033/S001)Asahi Kasei Medical Co., Ltd.1986-01-08
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