Panels › General, Plastic Surgery › Product code KOY · Class 1
Degreaser, Skin, Surgical
Regulation 878.4730
0510(k)s in 12 months (0 all time)
0recalls in 12 months (20 all time)
4recalls that name a 510(k)
Top companies in KOY
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien LLC | 0 | 10 |
| Carroll-Baccari, Inc. | 0 | 6 |
| Bio-Signal Group Corp. | 0 | 2 |
| Del Mar Reynolds Medical, Ltd. | 0 | 1 |
| Neuronetrix Solutions, LLC dba Cognision | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2019 | Carroll-Baccari, Inc. Wave Prep Tubes (1710-03) and single use cups (17--00-24) Terminated |
KOY | None listed |
| Dec 23, 2019 | Carroll-Baccari, Inc. MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24 Terminated |
KOY | None listed |
| Dec 23, 2019 | Carroll-Baccari, Inc. PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP) Terminated |
KOY | None listed |
| Dec 23, 2019 | Carroll-Baccari, Inc. LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) Terminated |
KOY | None listed |
| Dec 18, 2019 | Bio-Signal Group Corp. HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact b Terminated |
KOY | K970694 |
| Dec 18, 2019 | Bio-Signal Group Corp. HydroDot brand:
Wave Prep 4 oz. tubes-Product 1710-03.
An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to re Terminated |
KOY | K970694 |
| Nov 7, 2019 | Neuronetrix Solutions, LLC dba Cognision Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes.
Order No. D5000, Part No. PN-1720 - Product Usa Terminated |
KOY | K970694 |
| Sep 5, 2019 | Carroll-Baccari, Inc. Pedia Prep:
MD0033T - 4 oz tubes
MD0033--SUP - Single Use Cups
Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.) Terminated |
KOY | None listed |
| Sep 5, 2019 | Carroll-Baccari, Inc. Lemon Prep:
MD0019T - 4 oz tubes
MD0019--SUP - Single Use Cups
Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.) Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE
Item Code: P4P16CSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PREM U/M 14FR SIL FLY
Item Code: P4P14SD P400
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover KIT/STERILE PRESERVE CULT
Item Code: 8000SA
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | K030813 K063442 +1 |
| Mar 21, 2016 | Covidien LLC Covidien Dover MIDSTREAM KIT RING CASTILE
Item Code: 4090SA
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover MIDSTREAM KIT CASTILE SOAP
Item Code: 2090SA
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover MIDSTREAM KIT CASTILE SOAP
Item Code: 2040SA
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover EASY CATCH MIDSTREAM KT W/CAST
Item Code: 25015
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP
Item Code: 24035
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL
Item Code: 24015
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover CATCH KIT SOAP
Item Code: 5205
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Nov 21, 2011 | Del Mar Reynolds Medical, Ltd. PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads .
Ho Terminated |
KOY | None listed |
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