Tuttnauer Ltd.
BEIT SHEMESH Jerusalem, IL
TUTTNAUER LTD. appears in FDA device records in BEIT SHEMESH Jerusalem, IL. FDA records list 10 510(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 10 510(k) clearances for Tuttnauer Ltd. between 1984 and 2022. The busiest year on record is 2022, with 3. The most recent is 2022, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1993 | 1 |
| 2001 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| 2019 | 1 |
| 2022 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | FLE | Substantially Equivalent | |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | FLE | Substantially Equivalent | |
| K213080 | T-Edge 10, T-Edge 11 | FLE | Substantially Equivalent | |
| K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | FLE | Substantially Equivalent | |
| K111736 | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES | FLE | Substantially Equivalent | |
| K063711 | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA | FLE | Substantially Equivalent | |
| K003470 | EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 | FLE | Substantially Equivalent | |
| K920478 | TUTTNAUER LSI (AUTOMATIC) | FLE | Substantially Equivalent | |
| K850264 | TUTTNAUER PRE-VACUUM AUTOCLAVE | FLE | Substantially Equivalent | |
| K833837 | AMERICAN GOLD SERIES AUTOCLAVE | FLE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8030087 | 3005343391 | TUTTNAUER LTD. | HAR-TUV INDUSTRIAL ZONE, BEIT SHEMESH Jerusalem 9910101 IL | 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