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Gastroenterology, Urology

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

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RecordFirmDate
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S001)Medtronic Neuromodulation1997-10-31
STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION) (P920051/S007)KARL STORZ Endoscopy-America, Inc.1997-10-31
MEDSTONE STS(TM) LITHOTRIPTER (P870015/S027)Medstone Intl., Inc.1997-10-31
UROLOGIC TARGIS SYSTEM (P970008/S003)Urologix, LLC1997-10-28
PROSTATRON (P950014/S007)Urologix, Inc.1997-10-27
PROSTATRON (P950014/S010)Urologix, Inc.1997-10-07
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004)Medtronic Neuromodulation1997-09-29
MEDSTONE STS(TM) LITHOTRIPTER (P870015/S026)Medstone Intl., Inc.1997-09-29
PROSTATRON (P950014/S009)Urologix, Inc.1997-09-24
H.E.L.P. SYSTEM (P940016)B. Braun Avitum AG1997-09-19
UROLOGIX TARGIS SYSTEM (P970008/S001)Urologix, LLC1997-08-28
TARGIS (T3) SYSTEM (P970008)Urologix, LLC1997-08-22
HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019)Healthtronics Surgical Services, Inc.1997-07-21
CONTIGEN BARD COLLAGEN IMPLANT (P900030/S006)Allergan, Inc.1997-07-11
ECONOLITH(TM) LITHOTRIPTER (P950043/S001)Medispec, Ltd.1997-06-30
DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE (P840008/S058)Dornier Medtech America, Inc.1997-05-05
UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS (P920023/S003)Boston Scientific Corp1997-04-29
MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE) (P840008/S057)Dornier Medtech America, Inc.1997-04-29
PROSORBA(TM) COLUMN (P850020/S009)Fresenius Hemocare, Inc.1997-04-17
UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS (P920023/S001)Boston Scientific Corp1997-04-11
ECONOLITH(TM) LITHOTRIPTER (P950043)Medispec, Ltd.1997-04-07
STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION) (P920051/S006)KARL STORZ Endoscopy-America, Inc.1997-03-27
TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS (P920034/S001)Medirex, Inc.1997-03-26
UVAR PHOTOPHORESIS SYSTEM (P860003/S028)Therakos Development Limited1997-03-25
REPRO-MED - THD (P820034/S005)Repro-Med Systems, Inc.1997-01-14
STORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION) (P920051/S004)KARL STORZ Endoscopy-America, Inc.1997-01-10
PROSTATRON (P950014/S003)Urologix, Inc.1996-12-27
STORZ MODULITH LITHOTRIPTER, MODEL SLX (P920051/S005)KARL STORZ Endoscopy-America, Inc.1996-12-27
DORNIER COMPACT S TRANSPORTABLE (P840008/S060)Dornier Medtech America, Inc.1996-12-20
DORNIER COMPACT S MOBILE (P840008/S059)Dornier Medtech America, Inc.1996-12-20
EDAP LT.02 SHOCK WAVE LITHOTRIPTER (P880042/S002)Edap International Corp.1996-12-18
PROSTATRON (P950014/S005)Urologix, Inc.1996-11-22
MEDSTONE STS(TM) LITHOTRIPTER (P870015/S025)Medstone Intl., Inc.1996-11-18
DORNIER COMPACT S (P840008/S056)Dornier Medtech America, Inc.1996-11-05
PROSTATRON (P950014/S004)Urologix, Inc.1996-10-29
MOBILE PROSTATRON (P950014/S002)Urologix, Inc.1996-10-16
DORNIER LITHOTRIPTER AND DORNIER LITHOTRIPTER TRANSPORTABLE (P840008/S054)Dornier Medtech America, Inc.1996-10-08
THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM (P860003/S025)Therakos Development Limited1996-10-03
UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS (P920023/S002)Boston Scientific Corp1996-09-27
PROSORBA(TM) COLUMN (P850020/S008)Fresenius Hemocare, Inc.1996-09-27
TRIPTER-X1 NOVA (P920034)Medirex, Inc.1996-09-20
GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER (P830063/S001)Vantive US Healthcare, LLC1996-08-28
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S022)Medstone Intl., Inc.1996-08-19
RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE (P960020)Uromed Corp.1996-08-16
STORZ MODULITH LITHOTRIPTER, MODEL SLX (P920051/S003)KARL STORZ Endoscopy-America, Inc.1996-06-21
LITHOSTAR (P870018/S016)Siemens Corp.1996-06-21
PROSTATRON (P950014/S001)Urologix, Inc.1996-06-20
LITHOSTAR LITHOTRIPTER SHOCK WAVE SYSTEM C (P870018/S014)Siemens Corp.1996-06-06
MOBILE LITHOSTAR WITH SHOCK WAVE SYSTEM C (SWSC) (P870018/S015)Siemens Corp.1996-06-05
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S024)Medstone Intl., Inc.1996-05-24
UVAR PHOTOPHORESIS SYSTEM (P860003/S027)Therakos Development Limited1996-05-17
UROLUME ENDOPROSTHESIS (P920023)Boston Scientific Corp1996-05-06
PROSTATRON (P950014)Urologix, Inc.1996-05-03
DORNIER LITHOTRIPTER MOBILE (P840008/S053)Dornier Medtech America, Inc.1996-04-11
LITHOSTAR (P870018/S013)Siemens Corp.1996-03-13
CONTIGEN BARD COLLAGEN IMPLANT (P900030/S005)Allergan, Inc.1996-03-08
LITHOSTAR SHOCK WAVE SYSTEM C (P870018/S011)Siemens Corp.1996-03-01
LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). (P910018)Kaneka Pharma America Corp.1996-02-21
CONTIGEN BARD COLLAGEN IMPLANT (P900030/S004)Allergan, Inc.1996-02-01
STORZ MODULITH (TM) LITHOTRIPTER (P920051/S001)KARL STORZ Endoscopy-America, Inc.1995-12-19
STORZ MODULITH (TM) LITHOTRIPTER (P920051/S002)KARL STORZ Endoscopy-America, Inc.1995-12-11
DORNIER LITHOTRIPTER TRANSPORTABLE (DLT) (P840008/S052)Dornier Medtech America, Inc.1995-10-05
DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (P840008/S051)Dornier Medtech America, Inc.1995-10-05
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S021)Medstone Intl., Inc.1995-09-15
TECHNOMED INTERNATIONAL SONOLITH 2000 (P880011/S003)Edap International Corp.1995-09-06
DORNIER LITHOTRIPTER (P840008/S050)Dornier Medtech America, Inc.1995-08-21
LITHOSTAR (P870018/S010)Siemens Corp.1995-07-13
UVAR PHOTOPHORESIS SYSTEM (P860003/S024)Therakos Development Limited1995-05-18
MODEL MFL 5000 LITHOTRIPTER (P840008/S045)Dornier Medtech America, Inc.1995-04-12
CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030/S003)Allergan, Inc.1995-03-03
STORZ MODULITH (TM) LITHOTRIPTER (P920051)KARL STORZ Endoscopy-America, Inc.1995-02-17
UVAR PHOTOPHORESIS SYSTEM (P860003/S023)Therakos Development Limited1995-01-26
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S019)Medstone Intl., Inc.1995-01-06
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S018)Medstone Intl., Inc.1994-12-22
CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030/S002)Allergan, Inc.1994-11-23
DORNIER LITHOTRIPTER COMPACT (P840008/S047)Dornier Medtech America, Inc.1994-09-12
DORNIER MFL5000 MOBILE LITHOTRIPTER (P840008/S049)Dornier Medtech America, Inc.1994-07-27
COBE CENTRY(R) TPE SYSTEM (P810023/S002)Gambro Bct, Inc.1994-07-05
LITHOSTAR (P870018/S008)Siemens Corp.1994-05-05
DORNIER LITHOTRIPTER COMPACT (P840008/S048)Dornier Medtech America, Inc.1994-05-04
LITHOSTAR (P870018/S009)Siemens Corp.1994-05-04
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S020)Medstone Intl., Inc.1994-04-19
THERASONIC LITHOTRIPSY TREATMENT SYSTEM (P890066/S005)Focus Surgery, Inc.1994-04-18
EDAP LT.01 SHOCK WAVE LITHOTRIPTER (P880042/S001)Edap International Corp.1994-04-18
TECHNOMED INTERNATIONAL SONOLITH 3000 (P880011/S008)Edap International Corp.1994-04-18
CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030/S001)Allergan, Inc.1994-03-28
UVAR PHOTOPHERESIS SYSTEM (P860003/S020)Therakos Development Limited1993-12-07
CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030)Allergan, Inc.1993-09-30
MODEL MFL 5000 LITHOTRIPTER (P840008/S046)Dornier Medtech America, Inc.1993-08-04
MODEL MFL 5000 MOBILE LITHOTRIPTER (P840008/S044)Dornier Medtech America, Inc.1993-07-19
REPRO-MED - THD (P820034/S004)Repro-Med Systems, Inc.1993-04-29
PROSORBA(TM) COLUMN (P850020/S006)Fresenius Hemocare, Inc.1993-04-29
PROSORBA(TM) COLUMN (P850020/S005)Fresenius Hemocare, Inc.1993-04-29
REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY (P820034/S003)Repro-Med Systems, Inc.1993-04-28
MODEL MFL5000 EXPANSION OF INDICATION RANGE (P840008/S040)Dornier Medtech America, Inc.1993-03-08
PROSORBA(TM) COLUMN (P850020/S004)Fresenius Hemocare, Inc.1993-02-20
MODEL HM4 LITHOTRIPTER CHANGE KV SETTING (P840008/S042)Dornier Medtech America, Inc.1992-12-08
DORNIER MODELS MFL5000 SHOCK WAVE LITHOTRIPTER (P840008/S038)Dornier Medtech America, Inc.1992-12-04
THERASONIC LITHOTRIPSY TREATMENT SYSTEM (P890066/S003)Focus Surgery, Inc.1992-10-29
DORNIER MODELS MPL9000 MODIFICATIONS (P840008/S039)Dornier Medtech America, Inc.1992-10-29
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