| RIGIDOMETER, MODEL DIR-4U (K061676) | Uroan 21 | 2006-12-27 |
| PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (K062042) | Plethora Solutions | 2006-09-06 |
| PREFTEST PROFESSIONAL SUITE (K052929) | Limestone Technologies, Inc. | 2006-04-26 |
| MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM (K033126) | Behavioral Technology, Inc. | 2003-10-29 |
| DIGITAL INFLECTION RIGIDOMETER (DIR) (K000194) | Uroan Xxi Electromedicina | 2000-04-10 |
| VISER PENILE TUMESCENCE MONITOR (K991479) | Laborie Medical Tech Corp. | 1999-07-07 |
| NEVA SYSTEM (K980627) | Urometrics, Inc. | 1998-04-07 |
| CAT-600 PENILE PLETHYSMOGRAPH (K936115) | Farrall Instruments, Inc. | 1995-01-10 |
| CAT-400UL PENILE PLETHYSMOGRAPH (K940128) | Farrall Instruments, Inc. | 1995-01-10 |
| RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (K941781) | Dacomed Corp. | 1994-08-25 |
| RT2 RIGIDITY AND TUMESCENCE TEST (K925931) | Compass Medical Technologies, Inc. | 1992-12-21 |
| BARD (R) ESKA ERECTIOMETER (K880903) | C.R. Bard, Inc. | 1988-05-06 |
| SURGITEK NPT MONITOR (K875333) | Surgitek | 1988-04-13 |
| NOCTURNAL PENILE TUMESCENCE MONITOR (K870983) | Texas Medical Electronics Co. | 1987-06-23 |
| VIBRECTOR (K851646) | Multicept, Aps. | 1985-08-21 |
| LFT - 212 (K841879) | Medical Monitoring Systems, Inc. | 1984-07-26 |
| DACOMED RIGISCAN SYSTEM (K841202) | Dacomed Corp. | 1984-07-06 |
| BIOREM 3000 & 4000 (K833454) | Biorem | 1984-02-21 |
| DACOMED SNAP-GAUGE (K832121) | Dacomed Corp. | 1983-07-18 |
| TUMISENSOR 1524 (K831251) | Life-Tech Intl., Inc. | 1983-06-03 |
| TUMISTORE RECORDER 1311 (K831252) | Life-Tech Intl., Inc. | 1983-05-18 |
| BEDSIDE N.P.T. 9900 - PRINTER 9800 (K830221) | Browne Medical, Inc. | 1983-03-17 |
| OREXAS POTENTEST (K830158) | Orexas Medical Corp. | 1983-02-07 |
| BIOREM 2000 (K822099) | Biorem | 1982-08-27 |
| DACOMED SNAP-GAUGE (K820615) | Dacomed Corp. | 1982-04-21 |
| PENILE ERECTION MONITOR (K810944) | Medical Monitoring Systems, Inc. | 1981-04-23 |