FDA Device Registration & Listing · Nancy Meurthe-et-Moselle, FR · Registration 3008717264
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2012-05-14 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2026-02-11 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | Clinical Chemistry | Class 2 | 862.1355 | 2026-02-11 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2017-04-27 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2019-11-25 |
| DPS | Electrocardiograph | Cardiovascular | Class 2 | 870.2340 | 2011-12-29 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | Class 2 | 870.1425 | 2011-12-29 |
| GCB | Needle, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2025-03-26 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | Cardiovascular | Class 2 | 870.2800 | 2018-05-14 |
| FRI | Scale, Stand-On, Patient | General Hospital | Class 1 | 880.2700 | 2026-04-08 |
| LEL | Device, Sleep Assessment | Neurology | Class 2 | 882.5050 | 2025-03-24 |
| GZO | Device, Galvanic Skin Response Measurement | Neurology | Class 2 | 882.1540 | 2025-03-24 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | Class 2 | 870.2910 | 2025-03-24 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2025-03-24 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2025-03-24 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2024-03-22 |
| BZG | Spirometer, Diagnostic | Anesthesiology | Class 2 | 868.1840 | 2024-03-22 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2017-08-25 |
| DPS | Electrocardiograph | Cardiovascular | Class 2 | 870.2340 | 2010-12-22 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2014-04-07 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2019-05-27 |
| QDK | Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | Clinical Chemistry | Class 2 | 862.1355 | 2019-06-25 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2025-01-29 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2017-04-19 |
| GKG | Centrifuge, Hematocrit | Hematology | Class 2 | 864.6400 | 2024-11-07 |
| FRW | Scale, Patient | General Hospital | Class 1 | 880.2720 | 2025-06-27 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-05-09 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2017-03-28 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2026-06-03 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | Cardiovascular | Class 2 | 870.2800 | 2010-12-22 |
| MEA | Pump, Infusion, Pca | General Hospital | Class 2 | 880.5725 | 2019-07-24 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2019-07-24 |
| FFX | System, Gastrointestinal Motility (Electrical) | Gastroenterology, Urology | Class 2 | 876.1725 | 2024-04-10 |
| DPS | Electrocardiograph | Cardiovascular | Class 2 | 870.2340 | 2017-09-21 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | Cardiovascular | Class 2 | 870.5300 | 2019-07-23 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Cardiovascular | Class 2 | 870.5550 | 2019-07-23 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | Class 3 | 870.5310 | 2019-07-23 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2019-07-23 |
| LIX | Aid, Cardiopulmonary Resuscitation | Cardiovascular | Class 2 | 870.5210 | 2019-07-23 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2018-04-23 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2025-02-04 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2025-02-04 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2023-12-06 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-12-06 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2023-12-06 |
| LIX | Aid, Cardiopulmonary Resuscitation | Cardiovascular | Class 2 | 870.5210 | 2023-12-06 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Cardiovascular | Class 2 | 870.5550 | 2023-12-06 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | Class 3 | 870.5310 | 2023-12-06 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | Cardiovascular | Class 2 | 870.5300 | 2023-12-06 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | Class 2 | 870.2300 | 2023-12-06 |
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | Class 2 | 884.2740 | 2019-02-04 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2025-11-26 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2019-11-27 |
| EWO | Audiometer | Ear, Nose, Throat | Class 2 | 874.1050 | 2025-05-09 |
| DPS | Electrocardiograph | Cardiovascular | Class 2 | 870.2340 | 2010-12-22 |
| NQE | Microscope, Specular | Ophthalmic | Class 2 | 886.1850 | 2025-02-17 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2025-07-25 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K934333 | 3M Medical Products Group | 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE | 1994-07-07 |
| K843874 | Beiersdorf, Inc. | LEUKOPOR SURGICAL TAPE | 1985-02-21 |
| K915446 | Sun Glitz Corp. | STRETCH WRAP | 1992-05-06 |
| K833120 | Acme United Corp. | ONE TIME COMPOUND BENZOIN TINCTURE- | 1983-12-29 |
| K870091 | Avery Intl. | IV SECUREMENT DEVICE USING PCCE THERMO. FILM | 1987-02-04 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0001-2011 | Baxter Healthcare Corp. Rt. | 2 | Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161. |
| Z-0002-2011 | Baxter Healthcare Corp. Rt. | 2 | Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163. |
| Z-0005-2025 | Zyno Medical LLC | 2 | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF;
Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z |
| Z-0006-2011 | CareFusion Corporation | 2 | CareFusion Alaris PC Unit Model 8015 (formerly Medley
PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December
20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems. |
| Z-0007-2012 | B Braun Medical, Inc | 2 | Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES
B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006
The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013522941 | JOHNSON MEDTECH LLC | Vandalia, OH, US |
| 3013873578 | SHANGHAI YUECHEN MEDICAL SUPPLY CO..LTD. | Shanghai, CN |
| 3003584029 | Braemar Manufacturing, LLC | San Diego, CA, US |
| 3017425211 | LOHMANN PRECISION DIE CUTTING, LLC | Orange, VA, US |
| 3008773647 | CARDIONET, LLC | Phoenix, AZ, US |
3008717264 when referencing this establishment in official correspondence.