510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Tambrands Inc.

Auburn, ME, US

TAMBRANDS INC. appears in FDA device records in Auburn, ME. FDA records list 70 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
70
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 70

FDA records hold 70 510(k) clearances for Tambrands Inc. between 1984 and 1996. The busiest year on record is 1987, with 20. The most recent is 1996, with 2.

Clearances by year, as a table
510(k) clearance decisions for Tambrands Inc., by decision year
YearClearances
19849
19852
198616
198720
19888
19899
19932
19941
19951
19962
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K962476UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATORHEBSubstantially Equivalent
K960341TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUSHEBSubstantially Equivalent
K952344SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUSHILSubstantially Equivalent
K944834UNSCENTED MENSTRUAL TAMPONSHEBSubstantially Equivalent
K924303TAMPAX TAMPON, REGULAR ABSORBENCYHEBSubstantially Equivalent
K923932TAMPAX TAMPONS, SUPER ABSORBENCYHEBSubstantially Equivalent
K896989TAMPAX TAMPONHEBSubstantially Equivalent
K896115TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPERHILSubstantially Equivalent
K896114TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.HEBSubstantially Equivalent
K896113TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUSHEBSubstantially Equivalent
K896112TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUSHEBSubstantially Equivalent
K891474TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATIONHHDSubstantially Equivalent
K891473TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIOHHLSubstantially Equivalent
K884951TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANTHHLSubstantially Equivalent
K884950TAMPAX ULTRAFIT PANTY SHIELDSHHDSubstantially Equivalent
K884446MAXITHINS SUPER PADS, DEODORANTHHLSubstantially Equivalent
K883530FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TESTCEPSubstantially Equivalent
K884445MAXITHINS PANTY SHIELDS, DEODORANTHHLSubstantially Equivalent
K884444MAXITHINS REGULAR PADS, DEODORANTHHLSubstantially Equivalent
K874823FIRST RESPONSE 5 MINUTE PREGNANCY TESTLCXSubstantially Equivalent
K880024TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUSHILSubstantially Equivalent
K880023TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPONHILSubstantially Equivalent
K880022TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPONHILSubstantially Equivalent
K872261TAMPAX DEODORANT TAMPON, SUPERHILSubstantially Equivalent
K872260TAMPAX DEODORANT TAMPON, SLENDER REGULARHILSubstantially Equivalent
K872259TAMPAX PETAL SOFT DEODORANT TAMPON, SUPERHILSubstantially Equivalent
K872258TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUSHILSubstantially Equivalent
K872257TAMPAX PETAL SOFT DEODORANT TAMPON, REGULARHILSubstantially Equivalent
K872256TAMPAX DEODORANT TAMPON, ORIGINAL REGULARHILSubstantially Equivalent
K872255TAMPAX DEODORANT TAMPON, SUPER PLUSHILSubstantially Equivalent
K871715ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONSHEBSubstantially Equivalent
K871716ULTRA MAXITHINS PADSHHDSubstantially Equivalent
K871642TAMPAX TAMPON, REGULARHEBSubstantially Equivalent
K864859SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONSHEBSubstantially Equivalent
K864652SUPER PLUS TAMPONSHEBSubstantially Equivalent
K864651SUPER TAMPONSHEBSubstantially Equivalent
K864650SLENDER REGULAR TAMPONSHEBSubstantially Equivalent
K864649REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONSHEBSubstantially Equivalent
K864648SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONSHEBSubstantially Equivalent
K870361TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU.HEBSubstantially Equivalent
K870360TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER PLUSHEBSubstantially Equivalent
K870359TAMPAX CLOSED-END FLUSHABLE TAMPON, ORIG. REGULARHEBSubstantially Equivalent
K870358TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPERHEBSubstantially Equivalent
K863464TAMPAX SUPER TAMPONSHEBSubstantially Equivalent
K862675MODIFIED DEODORANT MAXITHINS PANTY SHIELDSHHLSubstantially Equivalent
K862680MODIFIED REGULAR MAXITHINS PADS, UNSCENTEDHHDSubstantially Equivalent
K862679MODIFIED SUPER MAXITHINS PADS, UNSCENTEDHHDSubstantially Equivalent
K862678MODIFIED REGULAR DEODORANT MAXITHINS PADSHHLSubstantially Equivalent
K862677MODIFIED MAXITHINS PANTY SHIELDS UNSCENTEDHHDSubstantially Equivalent
K862676MODIFIED SUPER DEODORANT MAXITHINS PADSHHLSubstantially Equivalent

Registered establishments

FDA registered establishments for Tambrands Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12191091219109TAMBRANDS INC.2879 Hotel Rd, AUBURN, ME 04210 US2026

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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