Synergetics Inc
Medical device manufacturer in O Fallon, MO.
18510(k) clearances
0PMA approvals
37recalls
Device types
- GEI Electrosurgical, Cutting & Coagulation &… 4
- MPA Endoilluminator 3
- HQE Instrument, Vitreous Aspiration And… 2
- LFL Instrument, Ultrasonic Surgical 2
- GXD Generator, Lesion, Radiofrequency 2
- KZE Injector, Fluid, Non-Electrically Powered 1
- HQC Unit, Phacofragmentation 1
- GEX Powered Laser Surgical Instrument 1
- FRN Pump, Infusion 1
- HQB Photocoagulator And Accessories 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K160103 | Spetzler Malis Dual Illuminating Bipolar ForcepsGEI · Traditional | 10/12/2016SE |
| K143123 | Synergetics PHOTON EXMPA · Traditional | 02/24/2015SE |
| K121426 | Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsGEI · Traditional | 07/10/2012SE |
| K121675 | VersavitHQE · Traditional | 06/21/2012SE |
| K113857 | Synergetics Directional Endoocular Laser ProbeHQB · Traditional | 04/23/2012SE |
| K110924 | Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsGEI · Traditional | 12/07/2011SE |
| K091441 | Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube SetFRN · Traditional | 10/30/2009SE |
| K071482 | Stryker RF Multi-Lesion Generator, Model 0406-900-000GXD · Traditional | 12/20/2007SE |
| K063489 | Stryker Intradiscal RF GeneratorGXD · Traditional | 05/23/2007SE |
| K032598 | Synergetics Synerlight Fiber Optic LightsourceMPA · Traditional | 11/24/2003SE |
| K020220 | Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring CurretteLFL · Traditional | 08/23/2002SE |
| K010637 | Sonotome Ultrasonic Aspirator TipsLFL · Traditional | 04/20/2001SE |
| K990568 | Scrambled Endooto Laser Probe, Straight Tip, Model 59.02, Scrambled Endooto Laser Probe…GEX · Traditional | 05/14/1999SE |
| K982212 | Veritas Bipolar, Insulated, 0.5MM Tip, Model N301-005 Veritas Bipolar, Insulated 1.0MM…GEI · Traditional | 12/02/1998SE |
| K964005 | Synergetics Synerlight Fiber Optic LightsourceMPA · Traditional | 06/09/1997SE |
| K932668 | Ophthalmic Surgical Pneumatic Scissors DriverHQE · Traditional | 02/23/1994SE |
| K923725 | Ophthalmic Pharco NeedleHQC · Traditional | 03/18/1993SE |
| K923326 | Ophthalmic Viscoinjector DriveKZE · Traditional | 09/30/1992SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2254-2024 Class I | BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration…Sterilization certificates could not be validated by the supplier | 06/12/2024Open, Classified |
| Z-2253-2024 Class I | BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of…Sterilization certificates could not be validated by the supplier | 06/12/2024Open, Classified |
| Z-2252-2024 Class I | BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of…Sterilization certificates could not be validated by the supplier | 06/12/2024Open, Classified |
| Z-2251-2024 Class I | BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal…Sterilization certificates could not be validated by the supplier | 06/12/2024Open, Classified |
| Z-0122-2017 Class II | 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a…Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. | 08/11/2016Terminated |
| Z-0121-2017 Class II | 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part…Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. | 08/11/2016Terminated |
| Z-0120-2017 Class II | 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number…Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. | 08/11/2016Terminated |
| Z-0119-2017 Class II | 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E…Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. | 08/11/2016Terminated |
| Z-0899-2014 Class II | 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P.…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0898-2014 Class II | 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P.…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0897-2014 Class II | 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P.…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0896-2014 Class II | 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P.…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0895-2014 Class II | Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0894-2014 Class II | 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0893-2014 Class II | Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0892-2014 Class II | Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0891-2014 Class II | Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc.…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0890-2014 Class II | 25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0889-2014 Class II | 23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0888-2014 Class II | "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0887-2014 Class II | 27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0886-2014 Class II | Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS.…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0885-2014 Class II | 25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0884-2014 Class II | 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0883-2014 Class II | Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0882-2014 Class II | 23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0881-2014 Class II | 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0880-2014 Class II | 25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0879-2014 Class II | 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile /…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0878-2014 Class II | 29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P.…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0877-2014 Class II | 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0876-2014 Class II | 23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0875-2014 Class II | Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0874-2014 Class II | Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0873-2014 Class II | 23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P.…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0872-2014 Class II | Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6…Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could… | 12/09/2013Terminated |
| Z-0051-2014 Class II | Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number:…One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is… | 07/30/2013Terminated |