ClearanceBrief
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

CodeDeviceRecords
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days39
GEXPowered Laser Surgical Instrument16
MSDCatheter, Hemodialysis, Implanted16
KRACatheter, Continuous Flush6
DQOCatheter, Intravascular, Diagnostic2
DQYCatheter, Percutaneous2
OABLow Energy Direct Current Thermal Ablation System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 9, 2012Angiodynamics 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
DQOK061733
Feb 28, 2012Angiodynamics 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
KRAK082163
Feb 28, 2012Angiodynamics 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
KRAK082163
Feb 28, 2012Angiodynamics 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
KRAK082163
Feb 21, 2012Angiodynamics 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
LJSK093406
Feb 21, 2012Angiodynamics 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
LJSK093406
Jan 27, 2012Angiodynamics Worldwide Headquarters
NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101
Terminated
OABK080202
K102329
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 13, 2012Angiodynamics 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
GEXNone listed
Jan 12, 2012Angiodynamics 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
MSDK101843
Jan 12, 2012Angiodynamics 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
MSDK101843
Jan 12, 2012Angiodynamics 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
MSDK101843
Jan 12, 2012Angiodynamics 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
MSDK101843
Jan 12, 2012Angiodynamics 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
MSDK101843
Jan 12, 2012Angiodynamics 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
MSDK101843

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