fortimedix.comFMX314 Surgical Platform
Fortimedix Surgical B.V.
FORTIMEDIX SURGICAL B.V.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013186644 | 3013186644 | FORTIMEDIX SURGICAL B.V. | 1 | N | 2020-04-25 | Urmonderbaan 22 Geleen Limburg NL 6167 RD |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08719324463126 | symphonX™ - Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet. | +31454047470 | saleseurope@fortimedix.com |
| 08719324463126 | symphonX™ - Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet. | +18582440033 | salesusa@fortimedix.com |
| 08719324463133 | symphonX™ - Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet. | +31454047470 | saleseurope@fortimedix.com |
| 08719324463133 | symphonX™ - Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet. | +18582440033 | salesusa@fortimedix.com |
| 08719324463140 | symphonX™ - Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet. | +18582440033 | salesusa@fortimedix.com |
| 08719324463140 | symphonX™ - Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet. | +31454047470 | saleseurope@fortimedix.com |
| 08719324463157 | symphonX™ - Device for cutting or coagulating tissue; to be used in combination with an electrosurgical generator | +18582440033 | salesusa@fortimedix.com |
| 08719324463157 | symphonX™ - Device for cutting or coagulating tissue; to be used in combination with an electrosurgical generator | +31454047470 | saleseurope@fortimedix.com |
| 08719324463164 | symphonX™ - Device for irrigating/ aspirating | +18582440033 | salesusa@fortimedix.com |
| 08719324463164 | symphonX™ - Device for irrigating/ aspirating | +31454047470 | saleseurope@fortimedix.com |
| 08719324463171 | symphonX™ - Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures | +18582440033 | salesusa@fortimedix.com |
| 08719324463171 | symphonX™ - Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures | +31454047470 | saleseurope@fortimedix.com |
| 08719324463188 | symphonX™ - The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery. | +31454047470 | saleseurope@fortimedix.com |
| 08719324463188 | symphonX™ - The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery. | +18582440033 | salesusa@fortimedix.com |
| 08719324463348 | symphonX™ - Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet. | +31454047470 | saleseurope@fortimedix.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 199042 | 1322142488 | K160797 | FMX314 Surgical Platform | OTJ | 2016-08-26 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OTJ | 1 | 2016-08-26 |
PMN#
GUDID#
symphonX™ - Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-02-15
symphonX™ - Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-08-25
symphonX™ - Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-02-15
symphonX™ - Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-02-15
symphonX™ - Device for cutting or coagulating tissue; to be used in combination with an electrosurgical generator
2017-02-15
symphonX™ - Device for irrigating/ aspirating
2017-02-15
symphonX™ - Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures
2017-02-15
symphonX™ - The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery.
2019-05-22
symphonX™ - The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery.
2019-05-22
symphonX™ - The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery.
2019-05-22
symphonX™ - The symphonX™ Introducer is intended to establish a path of entry for laparoscopic Instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the symphonX™ (short) Instruments.
2017-02-15
symphonX™ - The symphonX™ Handle is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).
2017-02-15
symphonX™ - The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).
2018-11-28
symphonX™ - The symphonX™ Handle with on/off ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).
2018-11-28
symphonX™ - Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-02-15
symphonX™ - Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-08-25
symphonX™ - Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-08-25
symphonX™ - Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-08-25
symphonX™ - Device for cutting or coagulating tissue; to be used in combination with an electrosurgical generator
2017-08-25
symphonX™ - Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-02-15
symphonX™ - Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-02-15
symphonX™ - Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
2017-02-15
symphonX™ - Device for cutting or coagulating tissue; to be used in combination with an electrosurgical generator
2017-02-15
symphonX™ - Device for irrigating/ aspirating
2017-02-15
symphonX™ - Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures
2017-02-15