Panels › Obstetrics/Gynecology › Product code HEB · Class 2
Tampon, Menstrual, Unscented
Regulation 884.5470
2510(k)s in 12 months (189 all time)
1recalls in 12 months (36 all time)
7recalls that name a 510(k)
Top companies in HEB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2026 | GOLD STAR DISTRIBUTION INC Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT,
ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER Open, Classified |
HEB | K081555 |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 3 Month Heavy Flow Bundle;
Model Number: FG-BNDL-PC-MM-IBHF; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 3 Month Regular Flow Bundle;
Model Number: FG-BNDL-PC-MM-IBRF; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 3 Month All in One Bundle;
Model Number: FG-BNDL-PC-MM-IBAIO; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 3 Month Trial Tampon Box;
Model Number: FG-TMP-MM-IB09090909; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 18 Coated Super and 18 Nude Super Tampons;
Model Number: FG-TMP-MM-IB00180018; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 18 Coated Regular and 18 Nude Regular Tampons;
Model Number: FG-TMP-MM-IB18001800; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 18 Coated Regular and 18 Coated Super Tampons;
Model Number: FG-TMP-MM-IB18180000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 36 Coated Super Tampons;
Model Number: FG-TMP-MM-IB00360000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Initiation 36 Coated Regular Tampons;
Model Number: FG-TMP-MM-IB36000000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 3 Month Heavy Flow Bundle;
Model Number: FG-BNDL-PC-MM-REFHF; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 3 Month Regular Flow Bundle;
Model Number: FG-BNDL-PC-MM-REFRF; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 3 Month All in One Bundle;
Model Number: FG-BNDL-PC-MM-REFAIO; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 3 Month Trial Tampon Box;
Model Number: FG-TMP-MM-REF09090909; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 18 Coated Super and 18 Nude Super Tampons;
Model Number: FG-TMP-MM-REF00180018; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 18 Coated Regular and 18 Nude Regular Tampons;
Model Number: FG-TMP-MM-REF18001800; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 18 Coated Regular and 18 Coated Super Tampons;
Model Number: FG-TMP-MM-REF18180000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 36 Coated Super Tampons;
Model Number: FG-TMP-MM-REF00360000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Refill 36 Coated Regular Tampons;
Model Number: FG-TMP-MM-REF36000000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Heavy Flow Bundle;
Model Number: FG-BNDL-PC-REFHF; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Regular Flow Bundle;
Model Number: FG-BNDL-PC-REFRF; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) All in One Bundle;
Model Number: FG-BNDL-PC-REFAIO; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) Trial Tampon Box;
Model Number: FG-TMP-REF04050504; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) 9 Coated Super and 9 Nude Super Tampons;
Model Number: FG-TMP-REF00090009; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) 9 Coated Regular and 9 Nude Regular Tampons;
Model Number: FG-TMP-REF09000900; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) 9 Coated Regular and 9 Coated Super Tampons;
Model Number: FG-TMP-REF09090000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) 18 Coated Super Tampons;
Model Number: FG-TMP-REF00180000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) 18 Coated Regular Tampons;
Model Number: FG-TMP-REF18000000; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) 9 Coated Regular Tampons and 9 Nude Regular Tampons;
Model Number: FG-TMP-RET09000900; Open, Classified |
HEB | None listed |
| Oct 28, 2025 | DAYE (ANNE'S DAY LTD) 9 Coated Super Tampons and 9 Nude Super Tampons;
Model Number: FG-TMP-RET00090009; Open, Classified |
HEB | None listed |
| Dec 11, 2018 | Kimberly-Clark Corporation U by Kotex Sleek, Regular Tampons, 3 Count Terminated |
HEB | K112635 |
| Dec 11, 2018 | Kimberly-Clark Corporation U by Kotex Sleek, Regular/Super Tampons, 34 Count Multipack Terminated |
HEB | K112635 |
| Dec 11, 2018 | Kimberly-Clark Corporation U by Kotex Sleek, Regular Tampons, 34 Count Terminated |
HEB | K112635 |
| Dec 11, 2018 | Kimberly-Clark Corporation U by Kotex Sleek, Regular Tampons, 18 Count Terminated |
HEB | K112635 |
| Jan 11, 2012 | Kimberly-Clark Corporation Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neen Terminated |
HEB | K896994 |
| Sep 22, 2010 | First Quality Hygienic Inc Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons Terminated |
HEB | K023479 |
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