FDA.reportPublic FDA data

BIONIX, LLC

Matched from indexed company URL: Bionix Corp.

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
0071464600074327245 - Portable Ear Irrigation System (110 v)+1(800)551-7096Bionix@bionix.com
0071464600075027275 - OtoClear Aquabot Sample+1(800)551-7096Bionix@bionix.com
0071464600098927247 - Sample, OtoClear® Ear Irrigation System (220V)+1(800)551-7096Bionix@bionix.com
00714646001528Lighted Articulating Ear Curettes - Refill - 2512+1(800)551-7096Bionix@bionix.com
00714646001535Lighted Magnetic Foreign Body Removal Tool - Lighted Magnetic Foreign Body Remover - 5ct+1(800)551-7096Bionix@bionix.com
00714646001559Rechargeable Light Source - Rechargeable Light Source - with wall adapter+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

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#

80 records. Showing 1-40. Next