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Gastroenterology, Urology

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

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RecordFirmDate
ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S033)Medtimo, Inc.2015-05-27
INTERSTIM THERAPY SYSTEM (P970004/S198)Medtronic Neuromodulation2015-05-18
INTERSTIM THERAPY SYSTEM (P080025/S093)Medtronic Neuromodulation2015-05-18
AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S059)Boston Scientific Corp2015-05-06
AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWL SPHINCTER (ABS) (P010020/S032)Boston Scientific Corp2015-05-06
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S108)Boston Scientific Corp2015-05-06
COAPTITE INJECTABLE IMPLANT (P040047/S039)Merz North America, Inc.2015-04-29
MAESTRO RECHARGEABLE SYSTEM (P130019/S005)Reshape Lifesciences, Inc.2015-04-24
MAESTRO RECHARGEABLE SYSTEM (P130019/S004)Reshape Lifesciences, Inc.2015-04-22
MAESTRO RECHARGEABLE SYSTEM (P130019/S003)Reshape Lifesciences, Inc.2015-04-22
LINX REFLUX MANAGEMENT SYSTEM (P100049/S012)Torax Medical2015-04-21
ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER,ETHICON ENDO-SURGERY GASTRIC BAND (P070009/S015)Obtech Medical GmbH2015-04-20
INTERSTIM THERAPY SYSTEM (P970004/S196)Medtronic Neuromodulation2015-04-17
MAESTRO RECHARGEABLE SYSTEM (P130019/S006)Reshape Lifesciences, Inc.2015-04-17
INTERSTIM THERAPY SYSTEM (P080025/S091)Medtronic Neuromodulation2015-04-17
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S079)Therakos Development Limited2015-04-16
AMS 800 URINARY CONTROL SPHINCTER (P000053/S058)Boston Scientific Corp2015-04-15
AMS ACTICON NEOSPHINCTER (P010020/S031)Boston Scientific Corp2015-04-15
AMS 700 INFLATABLE PENILE PROSTHESIS,AMS AMBICOR PENILE PROSTHESIS (N970012/S107)Boston Scientific Corp2015-04-15
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S106)Boston Scientific Corp2015-04-13
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S040)Coloplast Corp.2015-04-13
AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S057)Boston Scientific Corp2015-04-08
AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS) (P010020/S030)Boston Scientific Corp2015-04-08
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S103)Boston Scientific Corp2015-04-07
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S054)Boston Scientific Corp2015-04-07
INTERSTIM THERAPY SYSTEM (P970004/S194)Medtronic Neuromodulation2015-04-03
INTERSTIM THERAPY SYSTEM (P080025/S089)Medtronic Neuromodulation2015-04-03
INTERSTIM THERAPY SYSTEM (P970004/S195)Medtronic Neuromodulation2015-04-02
INTERSTIM THERAPY SYSTEM (P080025/S090)Medtronic Neuromodulation2015-04-02
INTERSTIM THERAPY SYSTEM (P080025/S088)Medtronic Neuromodulation2015-03-27
INTERSTIM THERAPY SYSTEM (P970004/S193)Medtronic Neuromodulation2015-03-27
INTERSTIM THERAPY SYSTEM (P970004/S192)Medtronic Neuromodulation2015-03-26
INTERSTIM THERAPY SYSTEM (P080025/S087)Medtronic Neuromodulation2015-03-26
THERAKOS CELLEXPHOTOPHERESIS SYSTEM (P860003/S078)Therakos Development Limited2015-03-19
INTERSTIM THERAPY SYSTEM (P970004/S190)Medtronic Neuromodulation2015-03-06
INTERSTIM THERAPY SYSTEM (P080025/S086)Medtronic Neuromodulation2015-03-06
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S043)Coloplast Corp.2015-03-05
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S042)Coloplast Corp.2015-03-04
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S041)Coloplast Corp.2015-03-04
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S044)Coloplast Corp.2015-02-23
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S055)Boston Scientific Corp2015-02-12
SOLESTA INJECTABLE GEL (P100014/S013)Palette Life Sciences2015-02-12
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT (N970012/S104)Boston Scientific Corp2015-02-12
INTERSTIM THERAPY SYSTEM (P080025/S085)Medtronic Neuromodulation2015-02-10
INTERSTIM THERAPY SYSTEM (P970004/S189)Medtronic Neuromodulation2015-02-10
INTERSTIM THERAPY SYSTEM (P970004/S188)Medtronic Neuromodulation2015-02-06
INTERSTIM THERAPY SYSTEM (P080025/S084)Medtronic Neuromodulation2015-02-06
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S077)Therakos Development Limited2015-02-03
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S102)Boston Scientific Corp2015-01-28
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S053)Boston Scientific Corp2015-01-28
LINX REFLUX MANAGEMENT SYSTEM (P100049/S011)Torax Medical2015-01-21
SOLESTA INJECTABLE GEL (P100014/S017)Palette Life Sciences2015-01-21
MAESTRO RECHARGEABLE SYSTEM (P130019)Reshape Lifesciences, Inc.2015-01-14
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S039)Coloplast Corp.2015-01-07
INTERSTIM THERAPY SYSTEM (P970004/S186)Medtronic Neuromodulation2014-12-22
INTERSTIM THERAPY SYSTEM (P080025/S082)Medtronic Neuromodulation2014-12-22
PROLIEVE THERMODILATATION SYSTEM (P030006/S027)Medifocus, Inc.2014-12-16
AMS 800TM URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S051)Boston Scientific Corp2014-12-08
AMS 700 TM INFLATABLE PENILE PROSTHESIS(IPP) WITH INHIBIZONE TREATMENT (N970012/S099)Boston Scientific Corp2014-12-08
AMS ACTION NEOSPHINCTER ARTIFICIAL BOWL SPHINCTER (ABS) (P010020/S028)Boston Scientific Corp2014-11-18
AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S052)Boston Scientific Corp2014-11-18
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S101)Boston Scientific Corp2014-11-18
COAPTITE INJECTABLE IMPLANT (P040047/S037)Merz North America, Inc.2014-11-12
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S100)Boston Scientific Corp2014-11-06
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S032)Medtimo, Inc.2014-11-05
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S038)Coloplast Corp.2014-11-04
PROLIEVE THERMODILATATION SYSTEM (P030006/S026)Medifocus, Inc.2014-10-24
MEDTRONIC INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S068)Medtronic Neuromodulation2014-10-17
MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S172)Medtronic Neuromodulation2014-10-17
INTERSTIM THERAPY SYSTEM (P080025/S081)Medtronic Neuromodulation2014-10-16
INTERSTIM THERAPY SYSTEM (P970004/S185)Medtronic Neuromodulation2014-10-16
DEFLUX INJECTABLE GEL (P000029/S079)Palette Life Sciences2014-10-10
SOLESTA INJECTABLE GEL (P100014/S016)Palette Life Sciences2014-10-10
INTERSTIM THERAPY SYSTEM (P970004/S183)Medtronic Neuromodulation2014-10-08
INTERSTIM THERAPY SYSTEM (P080025/S079)Medtronic Neuromodulation2014-10-08
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S028)Medtimo, Inc.2014-10-07
THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES (P060010/S012)Srs Medical2014-10-06
INTERSTIM THERAPY SYSTEM (P080025/S080)Medtronic Neuromodulation2014-10-03
INTERSTIM THERAPY SYSTEM (P970004/S184)Medtronic Neuromodulation2014-10-03
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S031)Medtimo, Inc.2014-09-24
MACROPLASTIQUE IMPLANTS (P040050/S011)Uroplasty, LLC2014-09-16
KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S007)KARL STORZ Endoscopy-America, Inc.2014-09-09
SOLESTA (P100014/S014)Palette Life Sciences2014-08-28
INTERSTIM IMPLANTABLE NEUROSTIMULATOR FOR BOWEL CONTROL (P080025/S078)Medtronic Neuromodulation2014-08-27
INTERSTIM, INTERSTIM II (P970004/S181)Medtronic Neuromodulation2014-08-27
INTERSTIM IMPLANTABLE NEUROSTIMULATOR FOR URINARY CONTROL (P970004/S182)Medtronic Neuromodulation2014-08-27
INTERSTIM, INTERSTIM II (P080025/S077)Medtronic Neuromodulation2014-08-27
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S036)Coloplast Corp.2014-08-25
THERAKOS UVAR XTS AND THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S076)Therakos Development Limited2014-08-21
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S037)Coloplast Corp.2014-08-13
KARL STORZ PHOTODYNAMIC D-LIGHT C(PDD) SYSTEM -D-LIGHT C LIGHT SOURCE (P050027/S006)KARL STORZ Endoscopy-America, Inc.2014-08-07
SOLESTA INJECTABLE GEL (P100014/S015)Palette Life Sciences2014-08-07
INTERSTIM (P970004/S180)Medtronic Neuromodulation2014-08-01
INTERSTIM (P080025/S076)Medtronic Neuromodulation2014-08-01
DEFLUX INJECTABLE GEL (P000029/S078)Palette Life Sciences2014-07-31
VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S075)Medtronic Neuromodulation2014-07-30
VERIFY EVALUATION SYSTEM FOR INTERSTIM THERPY FOR URINARY CONTROL (P970004/S179)Medtronic Neuromodulation2014-07-30
PROSTALUND CORETHERM SYSTEM AND PROSTALAND CORETHERM ACCESSORIES (P010055/S009)Prostalund AB2014-07-30
INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S074)Medtronic Neuromodulation2014-07-25
INTERSTIM THERAPY FOR UNINARY CONTROL (P970004/S178)Medtronic Neuromodulation2014-07-25
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