Micromedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
29
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1817-2017Class IINordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized usiOctober 20, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K241739Endoscopic Applicator, 41 cmJuly 15, 2024
K123847MALLEABLE TIP ENDOSCOPIC APPLICATORJanuary 8, 2013
K122526360 GAS ASSISTED ENDOSCOPIC APPLICATORNovember 16, 2012
K120608ENDOSCOPIC APPLICATORMarch 15, 2012
K102563SINGLE CANNULA EXTENDED APPLICATORMarch 15, 2011
K100754GRAFT DELIVERY SYSTEM MODEL SA-6115June 9, 2010
K073401EARPOPPER, MODEL EP-2000, EP-2100, EP-3000March 14, 2008
K061092BAXTER DUPLOSPRAY MIS APPLICATORSeptember 13, 2006
K051157INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSSeptember 1, 2005
K050340MICROMEDICS SPHENOID SINUS STENTApril 27, 2005
K042834MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATORFebruary 11, 2005
K033589BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOROctober 4, 2004
K012868MICROMEDICS FIBRIJET AEROSOL APPLICATOROctober 29, 2001
K993234MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESISNovember 10, 1999
K991670SILVERSTEIN MICROWICKAugust 26, 1999
K992138MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIESAugust 9, 1999
K982667MICROMEDICS NASAL SEPTAL BUTTONNovember 24, 1998
K940371SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIPApril 6, 1994
K912418SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBEDecember 20, 1991
K911785RHINO-GUARDOctober 7, 1991