FDA Device Registration & Listing · Orlando, FL, US · Registration 3009212837
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2023-08-10 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-08-10 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2019-09-05 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2019-09-05 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2019-09-05 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2019-09-05 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2019-09-05 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2019-09-05 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2019-09-05 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2019-09-05 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2019-09-05 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-02-01 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | Class 2 | 862.3700 | 2019-09-05 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2019-09-05 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2019-09-05 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2019-09-05 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2019-09-05 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2019-09-05 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | Class U | N/A | 2019-09-05 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2019-09-05 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2019-09-05 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2019-09-05 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2019-09-05 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2023-08-10 |
| FHO | Pneumoperitoneum Needle | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-08-10 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | Class 2 | 862.3910 | 2019-09-05 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2019-09-05 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2019-09-05 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2019-09-05 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2019-09-05 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2019-09-05 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2019-09-05 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2019-09-05 |
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | Class 2 | 862.3700 | 2019-09-05 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2019-09-05 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2019-09-05 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-08-10 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K970809 | Somnus Medical Technologies, Inc. | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | 1997-06-18 |
| K222793 | C.R. Bard, Inc. | WavelinQ Generator | 2022-10-17 |
| K002257 | Tecno Instruments (Pvt.) , Ltd. | TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 | 2000-10-19 |
| K193591 | Bowa-Electronics GmbH & Co. KG | ARC 400 | 2020-04-02 |
| K192128 | Sutter Medizintechnik GmbH | Sutter Arrowtip Monopolar Electrodes | 2019-10-04 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0031-06 | Rita Medical Systems | 2 | Rita Brand Habib 4X Electrosurgical Coagulator,
Catalog Number: 4401US;
Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826 |
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Z-0029-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures. |
| Z-0029-2013 | Alere San Diego, Inc. | 2 | Triage TOX Drug Screen Panel, Model# 94400.
Product Usage:
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007353760 | ENERGIST LIMITED | Swansea, GB |
| 3005064998 | RDI INC. | Mount Kisco, NY, US |
| 3020623326 | TRIWORKS GROUP S.R.L. | Palata Campobasso, IT |
| 3012616488 | BRERA MEDICAL INCORPORATED | Northborough, MA, US |
| 3012940012 | Sutter Medical Technologies USA Inc. | Alpharetta, GA, US |
3009212837 when referencing this establishment in official correspondence.