510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Siemens Hearing Instruments, Inc.

Piscataway, NJ, US

Siemens Hearing Instruments, Inc. appears in FDA device records in Piscataway, NJ. FDA records list 42 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
42
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 42 510(k) clearances for Siemens Hearing Instruments, Inc. between 1984 and 2007. The busiest year on record is 1989, with 6. The most recent is 2007, with 1.

Clearances by year, as a table
510(k) clearance decisions for Siemens Hearing Instruments, Inc., by decision year
YearClearances
19842
19871
19881
19896
19905
19913
19923
19933
19945
19956
19961
19971
20014
20071
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)ETWSubstantially Equivalent
K011364CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)KLWSubstantially Equivalent
K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)KLWSubstantially Equivalent
K003559TCI (TINNITUS CONTROL INSTRUMENT)KLWSubstantially Equivalent
K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)ESDSubstantially Equivalent
K972998PRISMAESDSubstantially Equivalent
K962170SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PPESDSubstantially Equivalent
K952940PERSONAL PROGRAMMER 2000ESDSubstantially Equivalent
K951828FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENTESDSubstantially Equivalent
K952263PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENTESDSubstantially Equivalent
K951896INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENTESDSubstantially Equivalent
K952098SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITEETWSubstantially Equivalent
K943380SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTSESDSubstantially Equivalent
K944645SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTSESDSubstantially Equivalent
K944174LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTSESDSubstantially Equivalent
K935019INFINITY 252ESDSubstantially Equivalent
K934752SIEMENS MODEL 584 P-2ESDSubstantially Equivalent
K942857SIEMENS BTE HEARING AIDSESDSubstantially Equivalent
K931000SIEMENS MODEL 584-P-AI-DESDSubstantially Equivalent
K930999SIEMENS MODEL 584-P-AIESDSubstantially Equivalent
K930998SIEMENS MODEL 584-P-GCESDSubstantially Equivalent
K923380SIEMENS MODEL TRITON 3004 BESDSubstantially Equivalent
K923379SIEMENS MODEL INFINITI 1001 BESDSubstantially Equivalent
K921656LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLEESDSubstantially Equivalent
K914333SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTIONESDSubstantially Equivalent
K911811SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AIDESDSubstantially Equivalent
K911810SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AIDESDSubstantially Equivalent
K903760MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEMESDSubstantially Equivalent
K893576SIEMENS MODEL 284 PPESDSubstantially Equivalent
K893575SIEMENS MODEL 283 ASPESDSubstantially Equivalent
K893574SIEMENS MODEL 284 PP-AGCESDSubstantially Equivalent
K893573SIEMENS MODEL 284 PP-LESDSubstantially Equivalent
K891251BEHIND-THE-EAR HEARING AID MODEL 408 W-HESDSubstantially Equivalent
K891250BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PCESDSubstantially Equivalent
K891249BEHIND-THE-EAR HEARING AID MODEL 303 ASPESDSubstantially Equivalent
K891248BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-IESDSubstantially Equivalent
K891247BEHIND-THE-EAR HEARING AID MODEL 404 PP-PCESFSubstantially Equivalent
K884583BTE HEARING AID SIEMENS MODEL 284PP-ASPESDSubstantially Equivalent
K882678ITE HEARING AID, SIEMENS MODEL 007, WITH TELOSESDSubstantially Equivalent
K872152SIEMENS SILICONE IMPRESSION MATERIALESDSubstantially Equivalent
K840893CONFERETTE C2ESDSubstantially Equivalent
K833773CANAL HEARING AIDESDSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0988-2014Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain