510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Daye (Anne's Day Ltd)

London London, City of, GB

DAYE (ANNE'S DAY LTD) appears in FDA device records in London London, City of, GB. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
29
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Daye (Anne's Day Ltd), with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30366797303036679730DAYE (ANNE'S DAY LTD)4th Floor, London London, City of SE1 9HF GB2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 29
Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0407-2026Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0406-2026Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0405-2026Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0404-2026Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0403-2026Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0402-2026Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0401-2026Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0400-2026Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0399-2026Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0398-2026Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0397-2026Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0396-2026Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0395-2026Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0394-2026Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0393-2026Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0392-2026Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0391-2026Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0390-2026Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0389-2026Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0388-2026Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0387-2026All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0386-2026Trial Tampon Box; Model Number: FG-TMP-REF04050504;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0385-20269 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0384-20269 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;Product lacks 510(k) clearance.Class IIOpen, Classified
Z-0383-20269 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;Product lacks 510(k) clearance.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain