Tracoe Medical GmbH
NIEDER-OLM Rhineland-Palatinate, DE
TRACOE MEDICAL GMBH appears in FDA device records in NIEDER-OLM Rhineland-Palatinate, DE. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Tracoe Medical GmbH between 1978 and 2021. The busiest year on record is 2005, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1996 | 1 |
| 2005 | 2 |
| 2016 | 2 |
| 2018 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203362 | TRACOE vario | JOH | Substantially Equivalent | |
| K172720 | TRACOE silcosoft Tracheostomy Tube | JOH | Substantially Equivalent | |
| K152778 | TRACOE Cuff Pressure Monitor | BSK | Substantially Equivalent | |
| K152865 | TRACOE smart Cuff Manager | BSK | Substantially Equivalent | |
| K051587 | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 | BTO | Substantially Equivalent | |
| K043160 | TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO | JOH | Substantially Equivalent | |
| K961449 | TRACHEOSTOMY TUBES TRACOE-FLEX | JOH | Substantially Equivalent | |
| K781729 | TRACHEOTOMY TUBES | BTO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010485 | 3003361161 | TRACOE MEDICAL GMBH | REICHELSHEIMER STR. 1/3, NIEDER-OLM Rhineland-Palatinate D-55268 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain