Synergetics, Inc.
Synergetics, Inc. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 2012, with 37 FDA device recalls on record.
Top product codes for Synergetics, Inc.
FDA recalls by Synergetics, Inc.
10 most recent of 37- Z-2252-2024 — BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
- Z-2254-2024 — BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
- Z-2251-2024 — BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
- Z-2253-2024 — BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
- Z-0119-2017 — 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Z-0122-2017 — 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
- Z-0120-2017 — 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Z-0121-2017 — 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Z-0897-2014 — 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Z-0883-2014 — Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Synergetics, Inc.
- K121426 — AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
- K121675 — VERSAVIT
- K113857 — SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
- K110924 — DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
- K091441 — SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
- K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
- K063489 — STRYKER INTRADISCAL RF GENERATOR
- K032598 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
- K020220 — ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
- K010637 — SONOTOME ULTRASONIC ASPIRATOR TIPS
- K990568 — SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01
- K982212 — VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
- K964005 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
- K932668 — OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
- K923725 — OPHTHALMIC PHARCO NEEDLE
- K923326 — OPHTHALMIC VISCOINJECTOR DRIVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.