Panels › Ophthalmic › Product code KYG · Class 1
Device, Irrigation, Ocular Surgery
Regulation 886.4360
0510(k)s in 12 months (40 all time)
0recalls in 12 months (11 all time)
1recalls that name a 510(k)
Top companies in KYG
| Company | 510(k)s | Recalls |
|---|---|---|
| Oasis Medical Inc | 0 | 7 |
| Visitec Co. | 3 | 0 |
| B&B Medical Assoc., Inc. | 2 | 0 |
| Insight Instruments, Inc. | 0 | 2 |
| Jedmed Instrument Co. | 2 | 0 |
| Med-Logics, Inc. | 2 | 0 |
| Mortan, Inc. | 2 | 0 |
| Optical Micro Systems, Inc. | 2 | 0 |
| Site Microsurgical Systems, Inc. | 2 | 0 |
| Surgeon Surgical Instrumentation, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2001 | K010353 | MED-LOGICS DISPOSABLE ALK TUBING Med-Logics, Inc. | KYG |
| Dec 22, 2000 | K003036 | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 Retinalabs.Com | KYG |
| Dec 28, 1999 | K993591 | BLADEWORKS DISPOSABLE ALK TUBING Blade Works, Inc. | KYG |
| May 19, 1998 | K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM Allergan, Inc. | KYG |
| May 15, 1998 | K980647 | EYE IRRIGATOR MODEL #2020 Eye-Deal Ocular Safety Products, Inc. | KYG |
| Feb 19, 1998 | K974561 | MOISTAIR FLUID AIR TUBING SET American Medical Devices, Inc. | KYG |
| May 22, 1997 | K971173 | ML DISPOSABLE ALK TUBING Med-Logics, Inc. | KYG |
| Mar 25, 1997 | K970161 | HEDGES CORNEAL WETTING PAK Hedges Cwp, Inc. | KYG |
| Apr 15, 1996 | K954842 | D.O.R.C. VFI/VFE SYSTEM Dutch Ophthalmic USA, Inc. | KYG |
| Feb 8, 1995 | K945171 | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE Boston Surgical Products, Inc. | KYG |
| Aug 23, 1994 | K940392 | PEREGRINE PIC MINIPULATOR Peregrine Surgical , Ltd. | KYG |
| Feb 16, 1994 | K935226 | I/V POLE Optical Micro Systems, Inc. | KYG |
| Jan 25, 1994 | K935003 | ELECTRIC I/V POLE OR EIVP2 Optical Micro Systems, Inc. | KYG |
| Dec 6, 1993 | K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE Site Microsurgical Systems, Inc. | KYG |
| Dec 24, 1992 | K924999 | AUTOPOLE REGULATOR SYSTEM Escalon Trek Medical | KYG |
| Dec 23, 1992 | K924052 | INFINITY MICRO IRRIGATOR Infinity Surgical Technology, Inc. | KYG |
| Jul 27, 1992 | K922996 | MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS Chiron Vision Corp. | KYG |
| Jul 2, 1992 | K922180 | LEWICKY O.R.S. TUBING O.R. Specialties, Inc. | KYG |
| Mar 19, 1992 | K915808 | AQUEOUS PARACENTESIS PIPET Visitec Co. | KYG |
| Jan 23, 1992 | K914587 | GRIESHABER AIR/FLUID TUBING SET Grieshaber & Co. | KYG |
| Nov 21, 1990 | K904186 | SITE DIAPHRAGM CASSETTE Site Microsurgical Systems, Inc. | KYG |
| Aug 22, 1988 | K881518 | INFUSION HANDLE B&B Medical Assoc., Inc. | KYG |
| Aug 22, 1988 | K881517 | B & B I/A HANDPIECE B&B Medical Assoc., Inc. | KYG |
| Jul 1, 1988 | K881682 | ALCON SITE(R)-COMPATIBLE CASSETTE Alcon Laboratories | KYG |
| Jul 1, 1988 | K880543 | UNI-PORT Surgeon Surgical Instrumentation, Inc. | KYG |
| Jun 19, 1987 | K871454 | MORGAN THERAPEUTIC LENS Mortan, Inc. | KYG |
| Apr 28, 1986 | K861203 | MULTI-SPIKE Surgeon Surgical Instrumentation, Inc. | KYG |
| Apr 4, 1986 | K860544 | BACSTOP FILTER IRRIGATION SUPPLY KIT Staar Surgical Co. | KYG |
| Mar 31, 1986 | K861013 | ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) Ameritek, Inc. | KYG |
| Sep 11, 1985 | K853243 | VISITEC IRRIGATION CONTROL SYSTEM Visitec Co. | KYG |
| Mar 5, 1985 | K845039 | OPERAID DISPOS. IRRIGATING KNIFE Jedmed Instrument Co. | KYG |
| Nov 21, 1984 | K841807 | OPERAID NUCLEUS Jedmed Instrument Co. | KYG |
| Oct 4, 1983 | K832787 | ELECATH HEPARIN COATED THERMAL DILUTION Electro-Catheter Corp. | KYG |
| Jul 12, 1983 | K831996 | MICRO SURGICAL HANDLE Visitec Co. | KYG |
| Jan 5, 1983 | K821897 | LENS Mortan, Inc. | KYG |
| May 5, 1982 | K820889 | ASPIRATOR/IRRIGATOR OR I/A UNIT Mid Laboratories, Inc. | KYG |
| Apr 9, 1982 | K820680 | DISPOSABLE TUBING SETS Innovative Surgical Products, Inc. | KYG |
| Dec 22, 1980 | K802332 | INTRAJECT General Medical Engineering Corp. | KYG |
| Sep 30, 1980 | K801822 | NU-VISION DISP. OPHTHALMIC DRESSING TRAY Summit Optics, Inc. | KYG |
| Oct 20, 1976 | K760820 | NALGENE EMERGENCY EYE WASH Nagle Co. | KYG |
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