Siemens Hearing Instruments, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 42
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0988-2014 | Class II | Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pe | July 1, 2005 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | June 5, 2007 |
| K011364 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) | June 7, 2001 |
| K011366 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | June 1, 2001 |
| K003559 | TCI (TINNITUS CONTROL INSTRUMENT) | April 26, 2001 |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | April 24, 2001 |
| K972998 | PRISMA | September 5, 1997 |
| K962170 | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP | July 25, 1996 |
| K952940 | PERSONAL PROGRAMMER 2000 | July 26, 1995 |
| K951828 | FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT | June 30, 1995 |
| K952263 | PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT | June 5, 1995 |
| K951896 | INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT | May 30, 1995 |
| K952098 | SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE | May 25, 1995 |
| K943380 | SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS | January 5, 1995 |
| K944645 | SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INST | December 27, 1994 |
| K944174 | LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS | December 27, 1994 |
| K935019 | INFINITY 252 | September 7, 1994 |
| K934752 | SIEMENS MODEL 584 P-2 | September 7, 1994 |
| K942857 | SIEMENS BTE HEARING AIDS | August 22, 1994 |
| K931000 | SIEMENS MODEL 584-P-AI-D | April 12, 1993 |
| K930998 | SIEMENS MODEL 584-P-GC | April 12, 1993 |