FDA.reportPublic FDA data

BIOMERICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30089982563008998256BIOMERICS1N2026-01-016030 W Harold Gatty Drive Salt Lake City UT US 84116

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1484581167143075K191538Resectr Tissue Resection DeviceHIH2020-01-16
1484581855909851K182443Pristine Hemodialysis CatheterMSD2019-05-31
1484582038065327K1819045 FR Dual Lumen Piper PICCLJS2018-09-25
1484581103810524K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterPND2018-11-02
1484581837645293K173956Biowy PlCC CatheterLJS2018-05-21
1484581427399476K172899Vygon PICCsLJS2018-02-26
1484581721627082K142347Amedica Valeo II Interbody Fusion DeviceMAX2014-11-18
1484581578049785K142229Laparoscopic FMsealerGEI2015-01-02
1484581876196859K141484OPEN FMSEALERGEI2014-07-30
1484581253766021K130873VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07MPFH2013-09-13
1484581063649912K110439DOMAIN SURGICAL SYSTEMGEI2011-07-18
1484581445920703K033028ANEFIN, MODEL 100CBN2005-07-22
1484581381425365
1484581080698892
1484581081075037
1484581104092854
1484581106539308
1484581137229133
1484581156065671
1484581215031201
1484581220023159
1484581265185468
1484581293123235
1484581308395146
1484581346904928
1484581422601570
1484581495940352
1484581557689768
1484581601806446
1484581654280298
1484581677313621
1484581785291312
1484581983453043

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJS32018-09-25
GEI32015-01-02
HIH12020-01-16
MSD12019-05-31
PND12018-11-02
MAX12014-11-18
PFH12013-09-13
CBN12005-07-22

PMN#