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Vygon Corp.

US

Last updated May 23, 2026

Information

Country
US
Address
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Website
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Email
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (1773)

Page 9 of 36
DeviceModel / ReferenceRegistriesClassStatus
Vygon AMS-516
FDA UDI
Class IIActive
Vygon VYLF4008
FDA UDI
Class IIActive
Vygon 363.067
FDA UDI
Class IIActive
Vygon 828.77
FDA UDI
Class IIActive
Vygon CLG-1934
FDA UDI
Class IIActive
Vygon 368.47
FDA UDI
Class IIActive
Vygon AMS-435CV-1
FDA UDI
Class IIActive
Vygon 1270.02
FDA UDI
Class IIActive
Vygon AMS-9437CP-2
FDA UDI
Class IIActive
Vygon AMS-846CP-1
FDA UDI
Class IIActive
Vygon 535.05
FDA UDI
Class IActive
Vygon AMS-451
FDA UDI
Class IIActive
Vygon AMS-8126CP-2
FDA UDI
Class IIActive
Vygon AMS-9294
FDA UDI
Class IIActive
Vygon AMS-8325CP-1
FDA UDI
Class IIActive
Premicath 1261.207G
FDA UDI
Class IIActive
Vygon AMS-651
FDA UDI
Class IIActive
Vygon 2394.14
FDA UDI
Class IIActive
Vygon AMS-8526CP-1
FDA UDI
Class IActive
Vygon VAT5507
FDA UDI
Class IIActive
Vygon AMS-2001
FDA UDI
Class IIActive
Vygon AMS-8142CP-1
FDA UDI
Class IActive
Vygon AMS-8405CP-3
FDA UDI
Class IIActive
Vygon AMS-9983CP-1A
FDA UDI
Class IIActive
Vygon 340.14
FDA UDI
Class IIActive
Vygon AMS-9818CP-3
FDA UDI
Class IActive
Vygon 310.07
FDA UDI
Class IIActive
Vygon AMS-519-1
FDA UDI
Class IIActive
Vygon 1362.147
FDA UDI
Class IIActive
Vygon AMS-8167-1
FDA UDI
Class IActive
Vygon MBS-2250
FDA UDI
Class IIActive
Vygon 5562.313
FDA UDI
Class IIActive
Vygon AMS-582
FDA UDI
Class IIActive
Vygon VYML5D1001
FDA UDI
Class IIActive
Vygon 5562.513N
FDA UDI
Class IIActive
Vygon AMS-823CP
FDA UDI
Class IIActive
Vygon AMS-8165CP-3A
FDA UDI
Class IIActive
Vygon AMS-761
FDA UDI
Class IIActive
Vygon AMS-532
FDA UDI
Class IIActive
Vygon BN-300
FDA UDI
Class IIActive
Vygon AMS-952-1
FDA UDI
Class IIActive
Vygon AMS-8149-5
FDA UDI
Class IActive
Vygon AMS-596-2
FDA UDI
Class IIActive
Vygon 340.10
FDA UDI
Class IIActive
Vygon CLGY-2234
FDA UDI
Class IIActive
Vygon AMS-8344
FDA UDI
Class IActive
Vygon AMS-938-4
FDA UDI
Class IIActive
Vygon AMS-530
FDA UDI
Class IIActive
Vygon 828.99
FDA UDI
Class IIActive
Vygon AMS-436
FDA UDI
Class IIActive

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FDA Recalls (23)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Aug 28, 2014Z-0113-2015—terminated

Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.

Dec 17, 2012Z-0937-2013—terminated

Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

May 11, 2012Z-1798-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1806-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1801-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1808-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1807-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1800-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1805-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1797-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1804-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1803-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1799-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

May 11, 2012Z-1802-2012—terminated

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

Apr 26, 2011Z-2700-2011—terminated

Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.

Apr 26, 2011Z-2699-2011—terminated

Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.

Apr 19, 2011Z-2391-2011—terminated

Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.

Apr 19, 2011Z-2389-2011—terminated

Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.

Apr 19, 2011Z-2390-2011—terminated

Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.

Apr 19, 2011Z-2388-2011—terminated

Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.

Jun 27, 2005Z-0090-06—terminated

Guidewire protuding from tip of the catheter

Apr 9, 2003Z-0849-03—terminated

Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.

Apr 9, 2003Z-0850-03—terminated

Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.