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Gastroenterology, Urology

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

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RecordFirmDate
LIPOSORBER(R) LA-15 SYSTEM (P910018/S006)Kaneka Pharma America Corp.2000-08-21
TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S036)Medstone Intl., Inc.2000-07-26
LITHOSTAR MODULARIS (P870018/S025)Siemens Corp.2000-07-17
TITAN INFLATABLE PENILE PROSTHESIS (P000006)Coloplast Corp.2000-07-14
INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S010)Medtronic Neuromodulation2000-06-28
UROLOGIX TARGIS(TM) SYSTEM (P970008/S013)Urologix, LLC2000-06-05
LITHOSTAR MODULARIS (P870018/S024)Siemens Corp.2000-04-17
PROSTATRON (P950014/S020)Urologix, Inc.2000-04-13
INTERSTIM SYSTEM FOR URINARY CONTROL (P970004/S008)Medtronic Neuromodulation2000-03-09
UVADEX(R) STERILE LIQUID (P860003/S033)Therakos Development Limited2000-03-06
UROLOGIX TARGIS SYSTEM (P970008/S014)Urologix, LLC2000-03-02
INTERSTIM SYSTEM FOR URINARY CONTROL THERAPY (P970004/S007)Medtronic Neuromodulation2000-02-29
TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S035)Medstone Intl., Inc.2000-02-25
UROLUME(R) ENDOPROSTHESIS (P920023/S010)Boston Scientific Corp2000-02-14
UROLUME ENDOPROSTHESIS (P920023/S011)Boston Scientific Corp2000-02-09
UVAR XTS PHOTOPHORESIS SYSTEM (P860003/S035)Therakos Development Limited2000-01-14
PROSORBA TREATMENT COLUMN FOR RA AND ITP (P850020/S012)Fresenius Hemocare, Inc.1999-12-17
LITHOTRON ULS (P970019/S006)Healthtronics Surgical Services, Inc.1999-12-17
UROLOGIX TARGIS SYSTEM (P970008/S012)Urologix, LLC1999-12-04
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S034)Therakos Development Limited1999-11-29
TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S034)Medstone Intl., Inc.1999-11-19
PROSTATRON PRAKTIS (P950014/S019)Urologix, Inc.1999-11-05
INTERSTIM CONTINENCE CONTROL SYSTEM (P970004/S006)Medtronic Neuromodulation1999-11-04
LIPOSORBER LA-15 SYSTEM (P910018/S001)Kaneka Pharma America Corp.1999-10-29
FEMSOFT URETHRAL INSERT (P990002)Rochester Medical Corp.1999-09-30
UROLUME ENDOPROSTHESES (P920023/S009)Boston Scientific Corp1999-09-17
DURASPHERE INJECTABLE BULKING AGENT (P980053)Carbon Medical Technologies, Inc.1999-09-13
UVAR PHOTOPHORESIS SYSTEM (P860003/S030)Therakos Development Limited1999-09-07
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S005)Medtronic Neuromodulation1999-09-03
DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE (P840008/S069)Dornier Medtech America, Inc.1999-09-02
ECONOLITH LITHOTRIPTER (P950043/S006)Medispec, Ltd.1999-08-27
HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM (P940016/S004)B. Braun Avitum AG1999-08-12
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S031)Therakos Development Limited1999-08-10
MEDSTONE STS-T LITHOTRIPTER (P870015/S033)Medstone Intl., Inc.1999-06-21
PROSTATRON (P950014/S018)Urologix, Inc.1999-05-19
UROLOGIX TARGIS SYSTEM (P970008/S011)Urologix, LLC1999-05-03
LITHOSTAR MULTILINE (P870018/S023)Siemens Corp.1999-04-30
HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM (P940016/S001)B. Braun Avitum AG1999-04-26
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S004)Medtronic Neuromodulation1999-04-15
UROLUME ENDOPROSTHESIS DELIVERY TOOL (P920023/S008)Boston Scientific Corp1999-04-13
RELIANCE URINARY CONTROL INSERT & SIZING DEVICE (P960020/S001)Uromed Corp.1999-04-01
UROLUME ENDOPROSTHESIS (P920023/S007)Boston Scientific Corp1999-03-29
PROSORBA(TM) COLUMN (P850020/S011)Fresenius Hemocare, Inc.1999-03-15
DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA (P840008/S067)Dornier Medtech America, Inc.1999-03-12
UROWAVE (P970044/S003)Dornier Medtech America, Inc.1999-03-12
MEDSTONE STS-T LITHOTRIPTER (P870015/S031)Medstone Intl., Inc.1999-03-11
DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE (P840008/S068)Dornier Medtech America, Inc.1999-02-26
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S010)Urologix, LLC1999-02-19
PROSTATRON, MAXIS AND PRAKTIS (P950014/S017)Urologix, Inc.1999-01-25
TRANSMOBILE LITHOSTAR MODULARIS (P870018/S022)Siemens Corp.1999-01-21
TRIPTER-X1 (P920034/S003)Medirex, Inc.1998-12-14
HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S003)Healthtronics Surgical Services, Inc.1998-11-18
LITHO TRON LITHOTRIPSY SYSTEM (P970019/S005)Healthtronics Surgical Services, Inc.1998-11-17
MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM (P970004/S003)Medtronic Neuromodulation1998-11-02
AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES (N970012)Boston Scientific Corp1998-11-02
RECTAL THERMOSENSING UNIT RTU (P970008/S009)Urologix, LLC1998-10-29
PROSTATRON (P950014/S016)Urologix, Inc.1998-10-14
UROLUME ENDOPROSTHESIS (P920023/S006)Boston Scientific Corp1998-10-02
MODULARIS LITHO (P870018/S021)Siemens Corp.1998-09-21
MEDSTONE STS-T TRANSPORTABLE LITHOTRIPTER (P870015/S030)Medstone Intl., Inc.1998-09-16
ECONOLITH(TM) LITHOTRIPTER (P950043/S005)Medispec, Ltd.1998-09-14
LITHOTRON ULTRA LITHOSTRIPSY SYSTEM (P970019/S004)Healthtronics Surgical Services, Inc.1998-09-11
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S032)Therakos Development Limited1998-09-01
LITHOSTAR MULTILINE (P870018/S017)Siemens Corp.1998-08-26
DORNIER COMPACT DELTA LITHOTRIPTER (P840008/S066)Dornier Medtech America, Inc.1998-08-21
PROSTATRON (P950014/S015)Urologix, Inc.1998-08-19
UROLOGIC TARGIS SYSTEM (P970008/S006)Urologix, LLC1998-07-27
UROLOGIC TARGIS SYSTEM (P970008/S008)Urologix, LLC1998-07-17
UROLUME(TM)ENDOPROSTHESIS (P920023/S004)Boston Scientific Corp1998-07-15
HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S002)Healthtronics Surgical Services, Inc.1998-07-14
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044/S002)Dornier Medtech America, Inc.1998-07-10
MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM (P970004/S002)Medtronic Neuromodulation1998-07-08
DORNIER COMPACT DELTA (P840008/S065)Dornier Medtech America, Inc.1998-07-07
UROLOGIC TARGIS SYSTEM (P970008/S007)Urologix, LLC1998-07-07
UROLUME(TM)ENDOPROSTHESIS (P920023/S005)Boston Scientific Corp1998-07-07
GENESTONE 190 LITHOTRIPTER (P970062)Bmt, Inc.1998-06-24
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044/S001)Dornier Medtech America, Inc.1998-06-23
DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) (P840008/S063)Dornier Medtech America, Inc.1998-06-19
PROSTATRON (P950014/S014)Urologix, Inc.1998-06-09
DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) (P840008/S064)Dornier Medtech America, Inc.1998-06-05
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044)Dornier Medtech America, Inc.1998-05-29
ECONOLITH(TM) LITHOTRIPTER (P950043/S004)Medispec, Ltd.1998-05-21
DORNIER LITHOTRIPTER AND DORNIER COMPACT S LITHOTRIPTER (P840008/S062)Dornier Medtech America, Inc.1998-05-14
ECONOLITH(TM) LITHOTRIPTER (P950043/S002)Medispec, Ltd.1998-05-05
MEDSTONE STS(TM) LITHOTRIPTER (P870015/S029)Medstone Intl., Inc.1998-03-27
PRAKTIS (P950014/S011)Urologix, Inc.1998-03-13
PROSTATRON MAXIS (P950014/S013)Urologix, Inc.1998-03-10
MEDSTONE STS(TM) LITHOTRIPTER (P870015/S028)Medstone Intl., Inc.1998-03-05
TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS (P920034/S002)Medirex, Inc.1998-03-05
UVAR PHOTOPHORESIS SYSTEM (P860003/S029)Therakos Development Limited1998-02-26
UROLOGIC TARGIS SYSTEM (P970008/S005)Urologix, LLC1998-02-20
PROSTATRON MAXIS (P950014/S012)Urologix, Inc.1998-01-22
UROLOGIC TARGIS SYSTEM (P970008/S002)Urologix, LLC1998-01-09
LITHOSTAR MULTILINE (P870018/S019)Siemens Corp.1997-12-29
UROLOGIC TARGIS SYSTEM (P970008/S004)Urologix, LLC1997-11-26
PROSTATRON (P950014/S006)Urologix, Inc.1997-11-24
HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S001)Healthtronics Surgical Services, Inc.1997-11-10
PROSTATRON (P950014/S008)Urologix, Inc.1997-11-07
SONOLITH 3000 LITHOTRIPTER (P880011/S009)Edap International Corp.1997-11-06
DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) (P840008/S061)Dornier Medtech America, Inc.1997-11-03
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