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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2023 | B. Braun Medical, Inc. AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use. Open, Classified |
KYG | K981116 |
| Aug 13, 2010 | Insight Instruments, Inc. BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411).
Manufactured Terminated |
KYG | None listed |
| Aug 13, 2010 | Insight Instruments, Inc. CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY.
Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA.
REF 60010.000, QTY 14 - This pa Terminated |
KYG | None listed |
| Jun 27, 2007 | Oasis Medical Inc Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals Irrigation/Aspiration Set 21 Gauge, Dual Port; Item #1721-A - Disposable Bimanual Aspiration Handpiece 2 Terminated |
KYG | None listed |
| Jun 27, 2007 | Oasis Medical Inc Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable Bimanuals Irrigation/Aspiration Set 20 Gauge, Dual Port; Item #1720-A - Disposable Bimanual Aspiration Handpiece 20g Terminated |
KYG | None listed |
| Jun 27, 2007 | Oasis Medical Inc Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A - Disposable Bimanual Aspiration Handpiece 19 Terminated |
KYG | None listed |
| Mar 29, 2007 | Becton Dickinson and Company BD Visitec Irrigating Cytosome, for use in cataract surgery.
Ref 581618 Terminated |
KYG | None listed |
| Oct 1, 2005 | Oasis Medical Inc OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri)
The -B4036V-NS cannula is placed into a vacuum formed plastic tray a Terminated |
KYG | None listed |
| Oct 1, 2005 | Oasis Medical Inc OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification MK-036V, LASIK Flap Irrigator (Vidaurri)
The MK-03V cannula is placed into a vacuum formed plastic tray and a bl Terminated |
KYG | None listed |
| Oct 1, 2005 | Oasis Medical Inc OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Ty Terminated |
KYG | None listed |
| Oct 1, 2005 | Oasis Medical Inc OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eig Terminated |
KYG | None listed |
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