ClearanceBrief
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)
Get daily alerts for KOYSample briefCSV

Top companies in KOY

Company510(k)sRecalls
Covidien LLC010
Carroll-Baccari, Inc.06
Bio-Signal Group Corp.02
Del Mar Reynolds Medical, Ltd.01
Neuronetrix Solutions, LLC dba Cognision01
DateFirm and productCodeLinked 510(k)
Dec 23, 2019Carroll-Baccari, Inc.
Wave Prep Tubes (1710-03) and single use cups (17--00-24)
Terminated
KOYNone listed
Dec 23, 2019Carroll-Baccari, Inc.
MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
Terminated
KOYNone listed
Dec 23, 2019Carroll-Baccari, Inc.
PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
Terminated
KOYNone listed
Dec 23, 2019Carroll-Baccari, Inc.
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
Terminated
KOYNone listed
Dec 18, 2019Bio-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
KOYK970694
Dec 18, 2019Bio-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
KOYK970694
Nov 7, 2019Neuronetrix 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
KOYK970694
Sep 5, 2019Carroll-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
KOYNone listed
Sep 5, 2019Carroll-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
KOYNone listed
Mar 21, 2016Covidien 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
KOYNone listed
Mar 21, 2016Covidien 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
KOYNone listed
Mar 21, 2016Covidien 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
KOYK030813
K063442 +1
Mar 21, 2016Covidien 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
KOYNone listed
Mar 21, 2016Covidien 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
KOYNone listed
Mar 21, 2016Covidien 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
KOYNone listed
Mar 21, 2016Covidien 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
KOYNone listed
Mar 21, 2016Covidien 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
KOYNone listed
Mar 21, 2016Covidien 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
KOYNone listed
Mar 21, 2016Covidien 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
KOYNone listed
Nov 21, 2011Del 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
KOYNone listed

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