Scott Bednar

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30034460423003446042Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30064411643006441164Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30073537603007353760Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30112245553011224555Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30126443273012644327Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30140151473014015147Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30169655643016965564Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30220998143022099814Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30276926243027692624Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30299069683029906968Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30303872923030387292Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30304906783030490678Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30310819593031081959Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009
30436039993043603999Scott Bednar1N2026-01-013335 Tuscarawas Rd Beaver PA US 15009

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2903711178578241K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)JXI2025-04-02
199591203536383K231053Unicare (K-UNICARE-USA)NUH2023-08-18
199591594750332K230983Unicare (K-UNICARE-USA)KPI2023-10-20
199591759427098K230926Ova+ (K-OVAP-USA)NUH2023-12-15
952571731617730K221873NeoGen PSR SystemGEI2023-01-12
3238961584659483K221123WISE Cortical Strip (WCS)GYC2022-11-22
246991683698082K213009Transcranial Doppler Ultrasound SystemIYN2022-07-08
199591884735349K210448Adhesive ElectrodeGXY2021-08-31
2903711731509159K201241Striate+™NPL2021-01-11
199591897366750K200694Perfect EMSNUH2021-06-04
199591852381073K192640Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast PumpHGX2020-03-30
199591688643265K191312Perfect PFEKPI2019-11-01
246991626045796K190228Transcranial Doppler Ultrasound SystemIYN2019-06-13
246991540639739K173801Transcranial Doppler Ultrasound SystemIYN2018-07-11
199591217593417K171721Electrodes with silver conductiveGXY2018-01-05
199591952968551K151284Electric Double Breast PumpsHGX2015-12-21
199591700000695K142506TensCare KegelFitKPI2015-04-20
199591302042635K140168EASYSTIM TN28_OTCNUH2014-08-28
952571218775336K132754NEOGEN PSR SYSTEMGEI2013-12-12
199591277410517K132588ADHESIVE ELECTRODESGXY2013-11-22
246991123474600K122710TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBANDIYN2013-02-15
199591740997078K122476LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANTNUC2013-03-07
199591322462634K103698TENSCARE ITOUCH SURE MODEL ITSKPI2011-06-21
246991611932616K092164TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UAOQQ2010-05-13
952571183753693K083748IPULSE, MODEL: I150GEX2009-02-02
952571139141104K082825ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEMGEX2009-02-06
199591398911517K082377TENSCARE ITOUCH MODEL(S) EASY AND PLUSGZJ2009-02-09
952571194924199K082197RHYTEC, INC., PORTRAIT PSRGEI2008-08-22
952571041321959K080406IPULSE, MODEL I400GEX2008-03-10
952571342631949K073111PORTRAIT PSR, MODEL 745915GEI2008-03-27
952571447475238K072394PORTRAIT STAND-OFFGEI2007-09-12
952571163220803K071883IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2GEX2008-01-23
952571315776357K071786PORTRAIT PSRGEI2007-07-26
952571207123346K060948PORTRAIT PSR3GEI2006-09-05
952572021249032K060216ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEMGEX2006-03-16
246991219591220K060112NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEMIYN2006-05-05
952571374564389K050165MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100GEX2005-04-19
952571571737275K041999GYRUS PLASMA SKIN RESURFACING SYSTEMGEI2005-03-02
952571511234511K040156IFL PROFESSIONAL SYSTEM, MODEL C100GEX2004-03-24
952571585932965K023111GYRUS PLASMA SKIN RESURFACING SYSTEMGEI2003-03-13
1743621012239366
1743621271522033
1743621707255764
1743621976322994
3267271101312923
3257211341328894
3478461386863471
3257211394568085
3238961551049089
199591554168746
3267271554186179
3478461646080412
3297691790677736
3267271793841782
3267271807982706
1924671864634538
3208421918516292
3297691984331989
3271102032363668
3297782032363668

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI92023-01-12
IYN82022-07-08
GEX72009-02-06
NUH42023-12-15
KPI42023-10-20
GXY32021-08-31
HGX22020-03-30
JXI12025-04-02
GYC12022-11-22
NPL12021-01-11
NUC12013-03-07
OQQ12010-05-13
GZJ12009-02-09