FDA Device Registration & Listing · Fairfield, OH, US · Registration 3005798905
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2026-01-06 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2024-04-08 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | Class 2 | 878.4850 | 2024-04-16 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2019-12-02 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2019-12-02 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2019-12-02 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2024-03-05 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2015-02-20 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | Class 2 | 862.1345 | 2014-04-18 |
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | Class 2 | 862.1345 | 2014-04-18 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2014-04-18 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2026-01-06 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2026-01-06 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2015-02-20 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2015-02-20 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | Class 2 | 878.4850 | 2024-04-16 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | Class 2 | 878.4850 | 2024-04-16 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2013-04-24 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2018-09-05 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2014-04-25 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2015-02-20 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2015-02-20 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | Class 2 | 862.1345 | 2011-12-07 |
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | Class 2 | 862.1345 | 2011-12-07 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2013-08-29 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2021-02-05 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2019-03-18 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | Class 2 | 878.4850 | 2009-12-16 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | Class 2 | 878.4850 | 2024-04-16 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | Class 2 | 878.4850 | 2024-04-16 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2024-04-08 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2009-07-09 |
No official correspondent registered.
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K092413 | Inviro Medical Devices, Inc. | INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES | 2009-09-04 |
| K163162 | Jiangxi Hongda Medical Equipment Group , Ltd. | Sterile Hypodermic Safety Syringes for Single Use | 2017-03-20 |
| K100940 | Andon Health Co, Ltd. | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 | 2010-06-29 |
| K251581 | Shenzhen Hingmed Medical Instrument Co., Ltd. | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | 2026-02-13 |
| K200521 | Health & Life Co., Ltd. | Full Automatic(NIBP) Blood Pressure Monitor | 2020-06-12 |
| 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. |
| Z-0044-2008 | Becton Dickinson & Company | 2 | Microtainer Safety Flow Lancets; Green
Sterile, Use Once and Discard;
1.4 mm Blade Length;
1.0mm Blade Width;
Becton Dickinson Vacutainer Systems;
Becton Dickinson & Company;
Franklin Lakes, NJ 07417 |
| Z-0003-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3027338968 | RONCADELLE OPERATIONS SRL | Castel Mella Brescia, IT |
| 3029328631 | PEGASUS IMPORTS | Houston, TX, US |
| 3012116434 | ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. | Taihu Anhui, CN |
| 3015528193 | Almac Pharma Services (Ireland) Limited | Dundalk Louth, IE |
| 3008719222 | ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd | HANGZHOU Zhejiang, CN |
3005798905 when referencing this establishment in official correspondence.