ENDOMAGNETICS LTD

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• MagtraceTM and Sentimag(R) Magnetic Locatization System

  2022-09-13

  ENDOMAGNETICS LTD.330 Cambridge Science Park, Milton Roadcambridge CB4 0 PMA NumberP160053 Supplement NumberS005 Date Received03/24/2022 Decision Date09/13/2022 Product Code PUV  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Tra...

• Magtrace/and Sentimag Magnetic Localization System

  2021-09-20

  ENDOMAGNETICS LTD.

• MagtraceTM and Sentimag(R) Magnetic Locatization System

  2019-05-08

  ENDOMAGNETICS LTD.

• MagtraceTM and Sentimag(R) Magnetic Locatization System

  2018-12-28

  ENDOMAGNETICS LTD.

• MagtraceTM and Sentimag(R) Magnetic Locatization System

  2018-07-24

  ENDOMAGNETICS LTD.

PMN#

• Magseed Pro Magnetic Marker System

  2024-06-28

  Endomagnetics Ltd.,

• Sentimag System

  2023-01-21

  Endomagnetics Ltd.,

• Magseed Magnetic Marker Systtem

  2018-02-16

  Endomagnetics Ltd.

• Magseed Magnetic Marker System

  2017-01-13

  ENDOMAGNETICS LTD

• Sentimag System, Sentimark Magnetic Marker Systerm

  2016-03-02

  ENDOMAGNETICS LTD.

GUDID#

• Sentimag Cart - The Sentimag Cart is indicated for use as a mobile support and storage accessory for the Sentimag Gen2 and Gen3 Systems. It is used to position, transport and store the Sentimag Systems during procedures for which they are indicated

  ENDOMAGNETICS LTD

  2026-07-07

• Magtrace - MTVC10-US

  ENDOMAGNETICS LTD

  2026-05-15

• Magtrace - Magnetic Tracer 10 Vials each containing 2ml of Magtrace. Magtrace is a magnetic tracer intended and calibrated for use with the Sentimag device only as part of an overall system to mark and locate lymph nodes in cancer patients prior to their surgical removal. Intended to be injected into interstitial tissue only in proximity to a tumor to facilitate its migration to sentinel lymph nodes for their subsequent localization by the Sentimag magnetometer.

  ENDOMAGNETICS LTD

  2023-06-20

• Magseed Pro - The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.

  ENDOMAGNETICS LTD

  2024-08-15

• Magseed Pro - The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.

  ENDOMAGNETICS LTD

  2024-08-15

• Sentimag - Standard Probe for Sentimag Gen 3

  ENDOMAGNETICS LTD

  2024-02-09

• Sentimag - Footswitch for Sentimag Gen 3

  ENDOMAGNETICS LTD

  2024-02-09

• Sentimag - Probe checker for Sentimag Gen 3 Probe

  ENDOMAGNETICS LTD

  2024-02-09

• Sentimag - Sentimag Gen 3 Base Unit

  ENDOMAGNETICS LTD

  2024-02-09

• Sentimag - Thin Probe for Sentimag Gen 3

  ENDOMAGNETICS LTD

  2024-02-09

• Sentimag Base Unit - The Sentimag system is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

  ENDOMAGNETICS LTD

  2023-06-20

• Sentimag SMP02 Probe Assembly - Device Description: The Sentimag is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

  ENDOMAGNETICS LTD

  2023-06-20

• Sentimag Footswitch Assembly - Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

  ENDOMAGNETICS LTD

  2023-06-20

• Sentimag SMC02 Probe Test Phantom - Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

  ENDOMAGNETICS LTD

  2023-06-20

• Magseed - Magseed MagneticTissue Marker Length 12cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue.

  ENDOMAGNETICS LTD

  2023-06-20

• Magseed - Magseed Magnetic Tissue Marker Length 7cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue.

  ENDOMAGNETICS LTD

  2023-06-20

• Sentimag SMH02 Probe Holder - Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

  ENDOMAGNETICS LTD

  2023-06-20

• Magseed Pro - The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.

  ENDOMAGNETICS LTD

  2024-08-15

• Magseed Pro - The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.

  ENDOMAGNETICS LTD

  2024-08-15