Pad, Eye
FDA product code HMP · Class I (low risk) · 21 CFR 878.4440 · General, Plastic Surgery
17510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Keeler Instruments, Inc. 2
- Nice-Pak Products, Inc. 1
- Medi-Spec 1
- Pollak (Intl.), Ltd. 1
- Secol Co. 1
- Conphar, Inc. 1
- Visitec Co. 1
- M.S.G. Health Systems, Inc. 1
- Rockway Enterprises, Inc. 1
- Xanmed Corp. 1
- Pantheon Products, Inc. 1
- Precision Therapeutics, Inc. 1
- Consolidated Industries of Greater Syracuse, Inc. 1
- Ulti-Med Intl., Inc. 1
- DeRoyal Industries Inc 1
- Certified Safety Mfg., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940333 | Eye PadHMP · Traditional | Certified Safety Mfg., Inc. | 03/07/1994SE |
| K921349 | Sterile,Disposable Eye DressingHMP · Traditional | Deroyal Industries, Inc. | 05/29/1992SE |
| K904896 | Eye PadHMP · Traditional | Ulti-Med Intl., Inc. | 12/05/1990SE |
| K883822 | First Aid Kit, Eye Dressing NSN6545-00-853-6309HMP · Traditional | Consolidated Industries of Greater Syracuse, Inc. | 11/22/1988SESD |
| K874411 | Donaldson Natural Eyepatch 'Patient Pak'HMP · Traditional | Keeler Instruments, Inc. | 01/27/1988SE |
| K864810 | LidsplintHMP · Traditional | Precision Therapeutics, Inc. | 01/20/1987SE |
| K861456 | Sheets Lyophilized Collagen HeyedratorHMP · Traditional | Pantheon Products, Inc. | 07/25/1986SN |
| K860979 | Donaldson Natural EyepatchHMP · Traditional | Keeler Instruments, Inc. | 04/04/1986SE |
| K851906 | Surgical Eye PackHMP · Traditional | Xanmed Corp. | 05/21/1985SE |
| K850099 | Visoprotect: Occular ShieldHMP · Traditional | Rockway Enterprises, Inc. | 03/20/1985SE |
| K850005 | Visoprotect Occular ShieldHMP · Traditional | M.S.G. Health Systems, Inc. | 03/20/1985SE |
| K843197 | Visitec Eye ShieldHMP · Traditional | Visitec Co. | 10/05/1984SE |
| K803145 | Conphar Eye ProtectorHMP · Traditional | Conphar, Inc. | 02/05/1981SE |
| K802799 | Eye PadsHMP · Traditional | Secol Co. | 12/17/1980SE |
| K801995 | Eye Pads CAT.#581-599HMP · Traditional | Pollak (Intl.), Ltd. | 09/09/1980SE |
| K800404 | Medspec Operative Opthalmic KitHMP · Traditional | Medi-Spec | 04/24/1980SE |
| K781539 | Iso-Care KitHMP · Traditional | Nice-Pak Products, Inc. | 11/03/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1131-2024 Class I | Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-1741-2017 Class II | Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists…Product sterility is compromised due to breach of sterile barrier | Covidien LLC | 03/03/2017Terminated |
| Z-1740-2017 Class II | Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841…Product sterility is compromised due to breach of sterile barrier | Covidien LLC | 03/03/2017Terminated |
| Z-1739-2017 Class II | Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists…Product sterility is compromised due to breach of sterile barrier | Covidien LLC | 03/03/2017Terminated |