FDA Device Registration & Listing · Widnau Sankt Gallen, CH · Registration 3003993690
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2013-04-20 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2009-06-11 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2011-04-12 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2020-02-28 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-05 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2009-11-05 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2013-04-20 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-05 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2008-01-28 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2010-06-10 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2008-05-15 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2007-12-05 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-05 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2013-04-20 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2010-06-23 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2008-11-23 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-05 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-02-21 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2007-12-05 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2013-04-20 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2007-12-05 |
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | Class 2 | 870.2100 | 2013-04-20 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-05 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-05 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2008-01-28 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2013-04-20 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2010-12-02 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2013-04-20 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2013-04-20 |
| BZH | Meter, Peak Flow, Spirometry | Anesthesiology | Class 2 | 868.1860 | 2013-04-20 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2010-11-23 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-05 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2013-04-20 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2013-04-20 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-05 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2011-07-21 |
| BZH | Meter, Peak Flow, Spirometry | Anesthesiology | Class 2 | 868.1860 | 2007-12-05 |
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | Class 2 | 870.2100 | 2013-04-20 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016867013 | ONFU electronics Co., LTD. | Trang Bom Dong Nai, VN |
| 8020605 | MICROLIFE CORP. | TAIPEI, TW |
| 9680225 | ONBO ELECTRONIC (SHENZHEN) CO. LTD. | SHENZHEN Guangdong, CN |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K010462 | Avita Corporation | AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) | 2001-04-11 |
| K760421 | Arbrook Mfg. Corp. | THERMOMETER, SURVALENT-ELECTRONIC | 1976-08-23 |
| K813409 | Yellow Springs Instrument Co., Inc. | MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER | 1981-12-18 |
| K830039 | Science Development Corp. | SDC RECTAL TEMP. PROBE PRODUCT #1020 | 1983-02-23 |
| K842199 | Sharp Electronics Corp. | ELEC. DIGITAL THERMOMETER MT-20 & 30 | 1984-07-18 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0032-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 |
| Z-0033-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. |
| Z-0034-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1062836 | DIGICARE BIOMEDICAL TECHNOLOGY, INC. | BOYNTON BEACH, FL, US |
| 3009487317 | SHENZHEN JUZHONG TECHNOLOGY CO.,LTD | shenzhen Guangdong, CN |
| 9681837 | ME CENTER OF TERUMO CORP. | FUJINOMIYA Shizuoka, JP |
| 3038761440 | Corsano Health SA | Plan-les-Ouates Geneve, CH |
| 3016595211 | DYNAMIC EMS LTD | Dalgety Bay Fife, GB |
3003993690 when referencing this establishment in official correspondence.