Company
Angiodynamics Worldwide Headquarters
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
82recalls (0 in 12 months)
81recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 39 |
| GEX | Powered Laser Surgical Instrument | 16 |
| MSD | Catheter, Hemodialysis, Implanted | 16 |
| KRA | Catheter, Continuous Flush | 6 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| DQY | Catheter, Percutaneous | 2 |
| OAB | Low Energy Direct Current Thermal Ablation System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheter Terminated |
DQO | K061733 |
| Feb 28, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60040 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, Terminated |
KRA | K082163 |
| Feb 28, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, Terminated |
KRA | K082163 |
| Feb 28, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, Terminated |
KRA | K082163 |
| Feb 21, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF Terminated |
LJS | K093406 |
| Feb 21, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] Terminated |
LJS | K093406 |
| Jan 27, 2012 | Angiodynamics Worldwide Headquarters NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101
Terminated |
OAB | K080202 K102329 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102638--- Made in the USA --- [Man Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Special Order Morpheus Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 6mL/sec --- Injector Pressure Limit --- Catalog No.: 52102624 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102618 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52100602 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 6F Triple Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110941 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110937 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110936 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110934 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110929 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110923 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Ass Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110919 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 6mL/sec --- Catalog No.: 12110918 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110917 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/SEC --- Catalog No.: 12110904 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and P Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104830 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104821 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104814 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104813 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104805 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104612 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104606 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104605 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102829 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102821 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102813 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102812 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102806 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102805 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 55cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102617 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102616 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102613 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102611 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102606 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102605 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102604 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4 mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12100805 --- Made in the USA --- [Manufacturing symbol Terminated |
LJS | K093406 |
| Jan 13, 2012 | Angiodynamics Worldwide Headquarters VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Terminated |
GEX | None listed |
| Jan 12, 2012 | Angiodynamics Worldwide Headquarters Angiodynamics DuraMax 55 cm STRAIGHT --- 1-15.5F x 55cm DuraMax Hemodialysis Catheter (with Cuff 50cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302909 --- MANUFACTURED IN USA AngioDynamics, Terminated |
MSD | K101843 |
| Jan 12, 2012 | Angiodynamics Worldwide Headquarters Angiodynamics DuraMax 24 cm STRAIGHT --- 1-15.5F x 24cm DuraMax Hemodialysis Catheter (with Cuff 19cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302903 --- MANUFACTURED IN USA AngioDynamics, Terminated |
MSD | K101843 |
| Jan 12, 2012 | Angiodynamics Worldwide Headquarters Angiodynamics DuraMax 22 cm STRAIGHT --- 1-15.5F x 22cm DuraMax Hemodialysis Catheter (with Cuff 17cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302902 --- MANUFACTURED IN USA AngioDynamics, Terminated |
MSD | K101843 |
| Jan 12, 2012 | Angiodynamics Worldwide Headquarters Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 55cm Chronic Hemodialysis VascPak (with Cuff 50cm from Tip) --- Catalog No. [REF] 10302824 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens Terminated |
MSD | K101843 |
| Jan 12, 2012 | Angiodynamics Worldwide Headquarters Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 40cm Chronic Hemodialysis VascPak (with Cuff 35cm from Tip) --- Catalog No. [REF] 10302822 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens Terminated |
MSD | K101843 |
| Jan 12, 2012 | Angiodynamics Worldwide Headquarters Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 32cm Chronic Hemodialysis VascPak (with Cuff 27cm from Tip) --- Catalog No. [REF] 10302820 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens Terminated |
MSD | K101843 |
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