FDA.reportPublic FDA data

BIONIX, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15268541526854BIONIX, LLC1Y2026-01-011670 Indianwood Circle Maumee OH US 43537

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00714646000736OtoClear SprayWash System, Single Use Sample - 27291+1(800)551-7096Bionix@bionix.com
00714646001153Clearlook Lighted Variety Pack - Clearlook Lighted Variety Pack, 50 curettes+1(800)551-7096Bionix@bionix.com
00714646001344ClearLook Lighted Variety Pack, Refill - ClearLook Lighted Variety Pack, 50ct Refill+1(800)551-7096Bionix@bionix.com
00714646001368ClearLook Lighted Variety Pack with Rechargeable Light Source - 3645+1(800)551-7096Bionix@bionix.com
00714646001375Rechargeable Light Source - Rechargeable Light Source with Magnification Lens+1(800)551-7096Bionix@bionix.com
00714646001627Lighted Magnetic Foreign Body Removal Tool - Lighted Magnetic Foreign Body Remover - 1ct+1(800)551-7096Bionix@bionix.com
10714646001532Lighted Magnetic Foreign Body Removal Tool - Lighted Magnetic Foreign Body Remover - 5ct+1(800)551-7096Bionix@bionix.com
10859911004792Tabletop Waterpik Adapter Wands - 27210+1(800)551-7096Bionix@bionix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
319581214571502K905164TUBE DECLOGGERKNT1991-02-13
319581315169488K180605GastroFlushKNT2018-10-24
319582040420134K153270TruGuard Custom Tongue and Jaw PositionerIYE2016-03-08
319581644850378K123411LITTLE ANGELS SWADDLING BLANKETPDH2013-03-07
319581697732765K120335EMBRACE THERMOPLASTICIYE2012-05-03
319581768101202K040773PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEMIYE2004-04-09
319581002996502
319581089961473
319581203543261
319581728811115
319581738136016
319581915659457
319581023390113
319581094130206
319581125524793
319581148877541
319581290526944
319581307213155
319581466245351
319581532202039
319581600834014
319581787433246
319581878852580
319581917768119
319581961396827
319581999344086
319582053801619

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE32016-03-08
KNT22018-10-24
PDH12013-03-07

PMN#

GUDID#

190 records. Showing 1-40. Next