Home › Device types › KOY
Degreaser, Skin, Surgical
FDA product code KOY · Class 1 · General, Plastic Surgery
9
Registered devices
81
Adverse events
20
Recalls
0
510(k) clearances
Devices with this code
Tech Stick — SPES MEDICA SPAElectrode Skin Prep Pads — Dynarex CorporationPDI® Electrode Prep Pad — PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.Adhesive Tape Remover Pads — Sion Brands LLCSion Biotext Medical Ltd. — SION BIOTEXT MEDICAL LTDAdhesive Tape Remover Pads, For Professional and Hospital Use — Dynarex CorporationSion Biotext Medical Ltd. — SION BIOTEXT MEDICAL LTDSafePrep — SPES MEDICA SPAAdhesive Tape Remover Pads — Sion Brands LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-12-23 | Carroll-Baccari, Inc. | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated wi |
| 2019-12-23 | Carroll-Baccari, Inc. | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated wi |
| 2019-12-23 | Carroll-Baccari, Inc. | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated wi |
| 2019-12-23 | Carroll-Baccari, Inc. | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated wi |
| 2019-11-07 | Neuronetrix Solutions, LLC dba Cognision | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia |
| 2019-10-29 | Bio-Signal Group Corp. | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) |
| 2019-10-29 | Bio-Signal Group Corp. | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) |
| 2019-09-05 | Carroll-Baccari, Inc. | Product has the potential to be contaminated with Burholderia cepacia. |
| 2019-09-05 | Carroll-Baccari, Inc. | Product has the potential to be contaminated with Burholderia cepacia. |
| 2016-01-22 | Covidien LLC | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.