| mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (K252605) | Medspira, LLC | 2025-12-05 |
| Solar Compact (G4-1) (K240007) | Laborie Medical Technologies, Corp. | 2024-05-06 |
| EndoflipTM 300 System (K231861) | Covidien, LLC | 2023-07-21 |
| EndoflipTM 300 (K223705) | Covidien, LLC | 2023-04-14 |
| Transit-Pellets (K222000) | Medifactia AB | 2023-01-18 |
| IntraMarX 3D Radiopaque Marker (K201106) | Anx Robotica Corp | 2020-05-21 |
| IntraMarX Radiopaque Markers (K191087) | Anx Robotica Corp | 2019-12-18 |
| Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (K190208) | Diversatek Healthcare | 2019-10-03 |
| Transit-Pellets (K181760) | Medifactia AB | 2019-08-08 |
| EndoFLIP System (K183072) | Crospon, Ltd. | 2019-02-15 |
| SITZMARKS (K181750) | Konsyl Pharmaceuticals | 2018-11-15 |
| EndoFLIP® System with FLIP Topography module (K170833) | Crospon, Ltd. | 2017-04-17 |
| Rapid Barostat Bag (RBB) Pump and Catheter (K160287) | Mui Scientific | 2017-03-14 |
| Lehman Manometry Catheter (K160170) | Wilson-Cook Medical, Inc. | 2016-06-20 |
| EndoFLIP (K160725) | Crospon, Ltd. | 2016-05-01 |
| ManoScan System (K151086) | Given Imaging , Ltd. | 2016-04-28 |
| ENDOFLIP CATHETER (K130906) | Crospon, Ltd. | 2013-07-17 |
| PRESSURIZED INFUSION PUMP (K122294) | Mui Scientific | 2012-11-01 |
| BAROSTAT SOFTWARE OPTION (K120997) | Crospon, Ltd. | 2012-08-27 |
| SOLAR GI (K121014) | Medical Measurement Systems B.V. | 2012-08-01 |
| SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM (K120524) | Mui Scientific | 2012-06-21 |
| ENDO FLIP (K102214) | Crospon, Ltd. | 2010-12-16 |
| PHTIP DISPOSABLE ISFET CATHETER (K102801) | E-Cath Co., Ltd. | 2010-10-26 |
| ENDOFLIP (K092850) | Crospon, Ltd. | 2009-12-15 |
| MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM (K091070) | Sierra Scientific Instruments, Inc. | 2009-05-19 |
| ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 (K082056) | Life-Tech, Inc. | 2008-11-07 |
| MODIFICATION TO SOLAR GI (K071094) | Medical Measurement Systems B.V. | 2007-08-13 |
| UNITIP HIGH RESOLUTION CATHETER (K062222) | Unisensor AG | 2007-03-15 |
| OHMEGA (K060166) | Medical Measurement Systems B.V. | 2006-04-21 |
| SOLAR GI (K052338) | Medical Measurement Systems B.V. | 2005-12-15 |
| SOLAR GI SYSTEM (K031084) | Medical Measurement Systems B.V. | 2004-03-19 |
| MOTILITY VISUALIZATION SYSTEM (K031169) | Sierra Scientific Instruments, Inc. | 2003-12-12 |
| BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER (K011471) | Medtronic Functional Diagnostics A/S | 2002-11-08 |
| INSIGHT, MODEL S980000 (K012232) | Sandhill Scientific, Inc. | 2002-06-07 |
| MARK II/MARK III MANOMETRIC PERFUSION PUMP (K013154) | Dentsleeve Pty., Ltd. | 2001-10-19 |
| POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID (K011472) | Medtronic Functional Diagnostics A/S | 2001-08-10 |
| UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER (K003580) | Unisensor AG | 2001-07-31 |
| SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 (K002427) | Sandhill Scientific, Inc. | 2001-06-22 |
| REDTECH GIPC 2000 (K004040) | Red-Tech, Inc. | 2001-03-29 |
| POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 (K010130) | Medtronic Functional Diagnostics A/S | 2001-02-07 |
| POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 (K000386) | Medtronic Functional Diagnostics A/S | 2000-05-05 |
| POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 (K992713) | Medtronic Functional Diagnostics A/S | 1999-11-10 |
| ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 (K991389) | Medtronic Functional Diagnostics A/S | 1999-07-15 |
| DISTENDER SERIES II BAROSTAT (K991288) | G & J Electronics, Inc. | 1999-06-08 |
| GASTRIC AND RECTAL CATHETERS (K973844) | G & J Electronics, Inc. | 1999-06-04 |
| INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 (K990441) | Sandhill Scientific, Inc. | 1999-05-12 |
| DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 (K981733) | Medtronic Functional Diagnostics A/S | 1999-02-04 |
| INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 (K984444) | Sandhill Scientific, Inc. | 1999-01-11 |
| MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 (K980980) | Konigsberg Instruments, Inc. | 1998-06-15 |
| MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP (K980946) | Dentsleeve Pty., Ltd. | 1998-06-08 |
| ANORECTAL MANOMETRY ANALYSIS MODULE (K972439) | Medtronic-Synectics | 1997-09-23 |
| ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM (K963064) | Laborie Medical Tech Corp. | 1997-06-05 |
| SMALL BOWEL ANALYSIS SOFTWARE (K942247) | Sandhill Scientific, Inc. | 1996-04-09 |
| ZINETICS AMC (K921682) | Zinetics Medical, Inc. | 1994-12-29 |
| MICROINFUSOR (K932306) | Sandhill Scientific, Inc. | 1994-04-01 |
| DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION (K920664) | Diagnostic Ultrasound Corp. | 1993-12-23 |
| GAELTEC MPR SERIES (K921062) | Medical Measurements, Inc. | 1992-07-30 |
| GASTROSCAN (K905154) | Medics Instrument Corp. | 1991-06-19 |
| WILSON-COOK BILIARY MOTILITY CATHETER (K900058) | Wilson-Cook Medical, Inc. | 1990-07-27 |
| AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. (K880581) | Synectics-Dantec | 1988-08-11 |
| SITZMARKS (K881609) | Lafayette Pharmacal, Inc. | 1988-07-08 |
| GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER (K874690) | Mentor Corp. | 1988-02-08 |
| MOTILITY MEASUREMENT SYS MMS-100 (K832869) | Narco Bio-Systems | 1983-10-31 |
| MICROCAPILLARY INFUSION SYSTEM (K831347) | J.S. Biomedicals, Inc. | 1983-06-02 |
| SYN-02 PN AMPLIFIER (K830421) | Biosearch Medical Products, Inc. | 1983-04-06 |
| MOTILITY CATHETERS (K823701) | Mui Scientific | 1983-02-15 |
| ESOPHAGEAL MOTILITY APPARATUS (K812103) | Honeywell, Inc. | 1981-08-13 |
| ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330 (K780812) | Honeywell, Inc. | 1978-06-13 |
| ESOPHAGEAL MOTILITY TUBE (K760761) | Sherwood Medical Industries | 1976-11-30 |