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Polymedica Industries, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K964398SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTEDOctober 24, 1997
K971045BASIS FLEXIBLE TIP DIGITAL THERMOMETERMay 2, 1997
K964701MITRAFLEX PIGMENTED WOUND DRESSINGFebruary 7, 1997
K963623SPYROFLEX PIGMENTED WOUND DRESSINGOctober 25, 1996
K962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERSeptember 12, 1996
K955383SPYROCOLLOID WOUND DRESSINGDecember 13, 1995
K953885SPYROFLEX SKIN PROTECTORNovember 29, 1995
K952756MEDI-AID BASAL THERMOMETERSeptember 25, 1995
K952159BASIS DIGITAL THERMOMETERSeptember 22, 1995
K953618SPYROFLEX WOUND DRESSINGAugust 21, 1995
K951862A GEL WOUND DRESSINGJuly 12, 1995
K952217MITRAFLEX WOUND DRESSING WET-STICKJune 22, 1995
K951730SPYROFOAM WOUND DRESSINGJune 16, 1995
K941673MEDIAID UNIVERSAL THERMOMETERAugust 25, 1994
K935783MITRAFLEX CAVITY WOUND DRESSINGFebruary 4, 1994
K932676SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)December 10, 1993