Company ยท US
Visitec Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1995. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HOZ | Sponge, Ophthalmic | 5 |
| HMX | Cannula, Ophthalmic | 3 |
| KYG | Device, Irrigation, Ocular Surgery | 3 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 |
| LZU | Plug, Punctum | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 |
| DRC | Trocar | 1 |
| EFQ | Gauze/Sponge, Internal | 1 |
| FHR | Needle, Gastro-Urology | 1 |
| FMF | Syringe, Piston | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FPK | Tubing, Fluid Delivery | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 |
| HJM | Transilluminator, Ac-Powered | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 |
| HMH | Rack, Skiascopic | 1 |
| HMP | Pad, Eye | 1 |
| HMT | Drape, Patient, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 12, 1995 | K953394 | VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} Visitec Co. | LZU |
| Feb 23, 1995 | K945114 | VISITEC SCLERAL PLUG Visitec Co. | LXP |
| Feb 14, 1995 | K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE Visitec Co. | HMT |
| Jan 17, 1995 | K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS Visitec Co. | HQX |
| Jul 12, 1994 | K942234 | VISITEC PRECISE-POINT Visitec Co. | GAP |
| May 17, 1994 | K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS Visitec Co. | HJM |
| Mar 7, 1994 | K940210 | VISITEC EYE PAD Visitec Co. | EFQ |
| Dec 27, 1993 | K933872 | VISI-SPEAR EYE SPONGE Visitec Co. | HOZ |
| Nov 4, 1992 | K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS Visitec Co. | FPK |
| Oct 20, 1992 | K922530 | VISITEC MICROSURGICAL SUTURE Visitec Co. | GAR |
| Sep 30, 1992 | K923645 | VISITEC ASPIRATING SYRINGE Visitec Co. | FMF |
| Mar 19, 1992 | K915808 | AQUEOUS PARACENTESIS PIPET Visitec Co. | KYG |
| Feb 24, 1992 | K915809 | VISITEC CANALICULAR STENT Visitec Co. | LZU |
| Apr 29, 1991 | K910516 | DISPOSAL PAD FOR SHARPS Visitec Co. | MMK |
| Feb 26, 1991 | K904074 | VITREORETINAL INFUSION CANNULA Visitec Co. | HMX |
| Jul 31, 1990 | K902857 | VISI-DRAPE OPHTHALMIC DRAPES Visitec Co. | HMY |
| Jul 26, 1990 | K902750 | VISI-SWAB OPHTALMIC SPONGE Visitec Co. | HOZ |
| Jun 20, 1990 | K902010 | VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE Visitec Co. | KGX |
| May 18, 1990 | K900786 | VISI-SORB ABSORBANT STICK Visitec Co. | HOZ |
| Apr 4, 1990 | K896622 | VISITEC VITRECTOMY UNIT Visitec Co. | HKP |
| Jan 11, 1990 | K896705 | VISITEC MICRO-SPONGE SPEARS Visitec Co. | HOZ |
| Jan 11, 1990 | K896681 | SOFT CORNEAL LIGHT SHIELD Visitec Co. | HOY |
| Feb 8, 1989 | K885232 | FLUID DRAINAGE WICK Visitec Co. | HOZ |
| Jan 31, 1989 | K884924 | VISI-WIPE Visitec Co. | HOF |
| Dec 13, 1985 | K853961 | VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 Visitec Co. | HQE |
| Dec 13, 1985 | K853035 | HESSBURG LIGHT GUARD Visitec Co. | HOY |
| Sep 24, 1985 | K852529 | HESSBURG GLIDE UNTRAOCULAR LENS GUIDES Visitec Co. | HQF |
| Sep 11, 1985 | K853243 | VISITEC IRRIGATION CONTROL SYSTEM Visitec Co. | KYG |
| Aug 12, 1985 | K852032 | OCULAR PRESSURE REDUCER (MCCANNEL) Visitec Co. | LCC |
| Aug 9, 1985 | K853135 | VISITEC 2 MICRON FLUID FILTER Visitec Co. | HQE |
| Mar 13, 1985 | K843487 | VISITEC OPHTHALMIC FLUID DISTRIB- SET Visitec Co. | HQC |
| Nov 29, 1984 | K844038 | VISITEC MAGNIFYING SPECTACLES Visitec Co. | HOI |
| Oct 5, 1984 | K843592 | VICO MICRO SURGICAL INSTRUMENTS Visitec Co. | HWQ |
| Oct 5, 1984 | K843197 | VISITEC EYE SHIELD Visitec Co. | HMP |
| Oct 5, 1984 | K843196 | VISITEC EYE SPECULUM Visitec Co. | HNC |
| Oct 5, 1984 | K843195 | VISITEC FLIERINGA-LEGRAND FIXATION RING Visitec Co. | HMH |
| Jul 12, 1983 | K831996 | MICRO SURGICAL HANDLE Visitec Co. | KYG |
| Jul 12, 1983 | K831901 | LACIMAL INTUBATION SETS Visitec Co. | HNL |
| Apr 9, 1982 | K820618 | MICROSURGERY KNIFE Visitec Co. | HNN |
| Oct 13, 1981 | K812723 | PEARCE CORNEAL TREPHINE Visitec Co. | HRH |
| Aug 25, 1981 | K811965 | VISITEC NEEDLE RANGE (GASTERUROLOGY) Visitec Co. | FHR |
| Aug 7, 1981 | K811960 | VISITEC NEDDLE TANGE (SURGERY) Visitec Co. | |
| Jul 23, 1981 | K811966 | VISITEC NEEDLE RANGE (GENERAL HOSPITAL) Visitec Co. | FMI |
| Jul 20, 1981 | K811964 | VISITEC NEEDLE RANGE (CARDIOVASCULAR) Visitec Co. | DRC |
| Jul 20, 1981 | K811961 | VISITEC NEEDLE RANGE (ORTHOPAEDIC) Visitec Co. | |
| Jul 16, 1981 | K811963 | VISITEC NEEDLE RANGE (ANESTHESIOLOGY) Visitec Co. | BSP |
| Feb 13, 1979 | K782169 | NEEDLES, CANNULAS, CYSTOTOMES Visitec Co. | HMX |
| Feb 12, 1979 | K790244 | CYSTOTOMES Visitec Co. | HNY |
| Feb 12, 1979 | K790243 | CANNULAS Visitec Co. | HMX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||