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Gastroenterology, Urology

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

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RecordFirmDate
DEFLUX INJECTABLE GEL (P000029/S047)Palette Life Sciences2008-07-10
INTERSTIM THERAPY: TORQUE WRENCH AND BOOK KIT, MODEL 3550-80 (P970004/S056)Medtronic Neuromodulation2008-07-03
INTERSTIM II MODEL 3058 NEUROSTIMULATOR (P970004/S057)Medtronic Neuromodulation2008-06-27
AMS UROLUME ENDOPROSTHESIS (P920023/S025)Boston Scientific Corp2008-06-27
DEFLUX INJECTABLE GEL (P000029/S046)Palette Life Sciences2008-06-25
DEFLUX INJECTABLE GEL (P000029/S045)Palette Life Sciences2008-06-18
COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS (P000006/S007)Coloplast Corp.2008-06-13
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S015)Boston Scientific Corp2008-05-30
UROLUME URETHRAL STENT (P920023/S024)Boston Scientific Corp2008-05-30
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S009)Boston Scientific Corp2008-05-30
THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S021)Boston Scientific Corp2008-05-30
MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01 (P970004/S054)Medtronic Neuromodulation2008-05-30
DEFLUX INJECTABLE GEL (P000029/S044)Palette Life Sciences2008-05-23
COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS (P000006/S009)Coloplast Corp.2008-05-23
INTERSTIM FAMILY OF NEUROSTIMULATORS (P970004/S055)Medtronic Neuromodulation2008-05-22
COAPTITE INJECTABLE IMPLANT (P040047/S004)Merz North America, Inc.2008-04-29
DEFLUX INJECTABLE GEL (P000029/S043)Palette Life Sciences2008-04-28
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S002)Srs Medical2008-04-25
INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S053)Medtronic Neuromodulation2008-04-25
MEDTRONIC INTERSTIM THERAPY (P970004/S049)Medtronic Neuromodulation2008-04-24
UROLOGIX TARGIS SYSTEM (P970008/S039)Urologix, LLC2008-04-23
INTERSTIM II NEUROSTIMULATOR (P970004/S052)Medtronic Neuromodulation2008-04-18
ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER (P010020/S006)Boston Scientific Corp2008-04-16
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S010)Boston Scientific Corp2008-04-16
TARGIS SYSTEM (P970008/S033)Urologix, LLC2008-04-15
INTERSTIM II NEUROSTIMULATOR (P970004/S051)Medtronic Neuromodulation2008-04-10
REALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT (P070009/S002)Obtech Medical GmbH2008-04-09
DEFLUX INJECTABLE GEL (P000029/S040)Palette Life Sciences2008-04-08
DEFLUX INJECTABLE GEL (P000029/S041)Palette Life Sciences2008-04-08
UROLOGIX TARGIS SYSTEM (P970008/S034)Urologix, LLC2008-04-07
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S036)Urologix, LLC2008-03-31
DEFLUX INJECTABLE GEL (P000029/S017)Palette Life Sciences2008-03-28
INTERSTIM NEUROSTIMULATOR (P970004/S048)Medtronic Neuromodulation2008-03-26
DEFLUX INJECTABLE GEL (P000029/S034)Palette Life Sciences2008-03-20
DEFLUX (P000029/S039)Palette Life Sciences2008-03-11
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S037)Urologix, LLC2008-03-10
DEFLUX (P000029/S037)Palette Life Sciences2008-03-07
UROLOGIX TARGIS SYSTEM (P970008/S035)Urologix, LLC2008-03-07
DEFLUX INJECTABLE GEL (P000029/S036)Palette Life Sciences2008-02-13
DEFLUX INJECTABLE GEL (P000029/S035)Palette Life Sciences2008-02-13
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S001)Srs Medical2008-02-12
ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPINCTER (P010020/S008)Boston Scientific Corp2008-02-05
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S014)Boston Scientific Corp2008-02-05
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S047)Therakos Development Limited2008-02-01
INTERSTIM THERAPY (P970004/S047)Medtronic Neuromodulation2008-01-17
CONTIGEN BARD COLLAGEN IMPLANT (P900030/S010)Allergan, Inc.2008-01-11
INTERSTIM FAMILY OF NEUROSTIMULATOR (P970004/S042)Medtronic Neuromodulation2008-01-11
DURASPHERE INJECTABLE BULKING AGENT (P980053/S011)Carbon Medical Technologies, Inc.2008-01-09
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S045)Medtronic Neuromodulation2007-12-18
THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S020)Boston Scientific Corp2007-12-17
INTERSTIM FAMILY OF NEUROSTIMULATOR (P970004/S046)Medtronic Neuromodulation2007-12-11
PROLIEVE THERMODILATATION SYSTEM (P030006/S013)Medifocus, Inc.2007-11-20
AMS 800 ARTIFICAL URINARY SPHINCTER (P000053/S012)Boston Scientific Corp2007-11-13
INTERSTIM NEUROSTIMULATOR (P970004/S044)Medtronic Neuromodulation2007-11-08
INTERSTIM FOR URINARY CONTROL (P970004/S041)Medtronic Neuromodulation2007-11-07
AMS 800 URINARY CONTROL SYSTEM (P000053/S013)Boston Scientific Corp2007-11-05
DEFLUX INJECTABLE GEL (P000029/S032)Palette Life Sciences2007-10-30
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S011)Boston Scientific Corp2007-10-24
PROLIEVE THERMODILITATION SYSTEM (P030006/S016)Medifocus, Inc.2007-10-24
ACTICON ARTIFICIAL BOWEL SPHINCTER (P010020/S007)Boston Scientific Corp2007-10-24
MEDTRONIC INTERSTIM TINED LEAD MODELS 3889 & 3093 (P970004/S040)Medtronic Neuromodulation2007-10-23
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S043)Medtronic Neuromodulation2007-10-15
COLOPLAST SALINE-FILLED TESTICULAR IMPLANT (P020003/S005)Coloplast Corp.2007-10-09
MACROPLASTIQUE IMPLANTS (P040050/S002)Uroplasty, LLC2007-10-03
REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X (P070009)Obtech Medical GmbH2007-09-28
LAP BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S010)Medtimo, Inc.2007-08-22
AMS UROLUME ENDOPROSTHESIS (P920023/S022)Boston Scientific Corp2007-08-08
THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM (P000043/S019)Boston Scientific Corp2007-08-03
UROLUME URETHRAL STENT (P920023/S021)Boston Scientific Corp2007-07-27
MACROPLASTIQUE IMPLANTS (P040050/S001)Uroplasty, LLC2007-07-27
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S005)Boston Scientific Corp2007-07-27
THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S018)Boston Scientific Corp2007-07-27
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S009)Boston Scientific Corp2007-07-27
DEFLUX INJECTABLE GEL (P000029/S027)Palette Life Sciences2007-07-10
PROLIEVE THERMODILATATION SYSTEM (P030006/S015)Medifocus, Inc.2007-07-10
PROLIEVE THERMODILATATION SYSTEM (P030006/S014)Medifocus, Inc.2007-07-03
LIPOSORBER LA-15 SYSTEM (P910018/S011)Kaneka Pharma America Corp.2007-06-27
COAPTITE (P040047/S003)Merz North America, Inc.2007-06-21
CORETHERM CATHETER (P010055/S004)Prostalund AB2007-06-19
DEFLUX INJECTABLE GEL (P000029/S033)Palette Life Sciences2007-06-18
THERMATRIX OFFICE THERMOTHERAPY SYSTEM (TMX-3000) (P000043/S017)Boston Scientific Corp2007-06-14
DEFLUX (P000029/S023)Palette Life Sciences2007-06-06
DEFLUX (P000029/S022)Palette Life Sciences2007-06-06
DEFLUX INJECTABLE GEL (P000029/S031)Palette Life Sciences2007-06-01
BIOFORM MEDICAL COAPTITE INJECTABLE IMPLANT (P040047/S002)Merz North America, Inc.2007-05-17
DEFLUX (P000029/S030)Palette Life Sciences2007-05-01
DEFLUX INJECTABLE GEL (P000029/S019)Palette Life Sciences2007-04-26
DEFLUX INJECTABLE GEL (P000029/S029)Palette Life Sciences2007-04-20
DEFLUX INJECTABLE GEL (P000029/S025)Palette Life Sciences2007-04-20
DEFLUX INJECTABLE GEL (P000029/S028)Palette Life Sciences2007-04-20
DEFLUX INJECTABLE GEL (P000029/S026)Palette Life Sciences2007-04-20
DEFLUX INJECTABLE GEL (P000029/S020)Palette Life Sciences2007-04-19
DEFLUX INJECTABLE GEL (P000029/S024)Palette Life Sciences2007-04-19
UROLUME URETHRAL STENT (P920023/S020)Boston Scientific Corp2007-04-17
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S004)Boston Scientific Corp2007-04-17
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S008)Boston Scientific Corp2007-04-17
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S031)Urologix, LLC2007-03-19
BARD TEGRESS URETHRAL IMPLANT (P030030/S005)C.R. Bard, Inc.2007-02-16
TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S010)Boston Scientific Corp2007-02-08
SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S007)Boston Scientific Corp2007-02-07
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Every clearance here is in the API, with alerts when new ones post.