FDA Device Registration & Listing · Glens Falls, NY, US · Registration 3017892510
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 | 2008-01-18 |
| OAB | Low Energy Direct Current Thermal Ablation System | General, Plastic Surgery | Class 2 | 878.4400 | 2024-12-16 |
| OAB | Low Energy Direct Current Thermal Ablation System | General, Plastic Surgery | Class 2 | 878.4400 | 2019-06-26 |
| NEY | System, Ablation, Microwave And Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-03-04 |
| NEY | System, Ablation, Microwave And Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-05-05 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3015537049 | ANGIODYNAMICS, INC | Queensbury, NY, US |
| 1000523114 | AngioDynamics, Inc. | Marlborough, MA, US |
| 1319211 | ANGIODYNAMICS, INC. | Queensbury, NY, US |
| 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-0015-2011 | Navilyst Medical, Inc | 2 | Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula.
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis. |
| Z-0025-2015 | Navilyst Medical, Inc | 2 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE ---
Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. |
| Z-0026-2015 | Navilyst Medical, Inc | 2 | BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE ---
Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. |
| Z-0027-2015 | Navilyst Medical, Inc | 2 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE ---
Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. |
| Z-0028-2015 | Navilyst Medical, Inc | 2 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE ---
Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. |
| Z-0029-2015 | Navilyst Medical, Inc | 2 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE ---
Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. |
| Z-0030-2015 | Navilyst Medical, Inc | 2 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 |
| Z-0031-2015 | Navilyst Medical, Inc | 2 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 |
| Z-0032-2015 | Navilyst Medical, Inc | 2 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE ---
Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. |
| Z-0033-2015 | Navilyst Medical, Inc | 2 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE ---
Intended for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. |
| Z-0034-2015 | Navilyst Medical, Inc | 2 | PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE ---
Indicated short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. |
| Z-0035-2015 | Navilyst Medical, Inc | 2 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE ---
Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. |
| Z-0036-2015 | Navilyst Medical, Inc | 2 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE ---
Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. |
| 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 |
3017892510 when referencing this establishment in official correspondence.