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NEOMED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30128657993012865799NEOMED CO., LTD.1N2026-01-0120, Jangnim-ro 196beon-gil Saha-gu Busan KR 49475
30139196533013919653NEOMEDLIGHT1N2026-01-01PARC EMMANUELLE LENNE 88 RUE FREDERIC FAYS VILLEURBANNE Auvergne-Rhone-Alpes FR 69100
30427084593042708459NEOMEDICO, LLC1Y2026-01-011408 E 13th Street Cheyenne WY US 82001
20325693003698071NEOMEDIX CORPORATION1N2020-04-2515042 Parkway Loop Suite A TUSTIN CA US 92780
30065207773006520777NeoMed, Inc.1Y2020-04-25100 Londonderry Ct Suite 112 Woodstock GA US 30188

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3471791533795386P980044SUPARTZ FXMOZ2001-01-24
3471791845450744P950027HYALGAN(R)MOZ1997-05-28
3471791642868079P940015SYNVISC ONEMOZ1997-08-08
3471791926842789P170007DUROLANEMOZ2017-08-29
3471791184434150P170002RHA 2, RHA 3, RHA 4LMH2017-10-19
3471791702021325P150010HYMOVISMOZ2015-08-28
3471791167352912P140029Restylane Refyne, Restylane DefyneLMH2016-12-09
3471791427076468P110033JUVEDERM VOLUMA XCLMH2013-10-22
3471791651212572P090031MONOVISCMOZ2014-02-25
3471791928883945P090016BELOTERO BALANCELMH2011-11-14
3471791381474420P050052RADIESSE INJECTABLE IMPLANTLMH2006-12-22
3471791111927659P050047JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTSLMH2006-06-02
3471791985971172P050037RADIESSE 1.3CC AND 0.3CCLMH2006-12-22
3471791897496856P040024RESTYLANE INJECTABLE GELLMH2005-03-25
3471791473445348P030050SCULPTRA AND SCULPTRA AESTHETICLMH2004-08-03
3471791262493418P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONANMOZ2004-02-04
3471791690964541P010029EUFLEXXA (1% SODIUM HYALURONATE)MOZ2004-12-03
710491204498520K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)PNR2019-04-30
2112551401570865K163526Bilicocoon™ Phototherapy SystemLBI2017-10-06
710491291801507K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)PNR2016-06-17
710491312299350K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsPNR2015-12-17
710491863124690K122373NEOMED ORAL/ENTERAL SYRINGEFMF2012-09-20
710491134930822K120182NEOMED GASTROINTESTINAL TUBE AND ACCESSORIESKNT2012-04-19
710491059222383K100288NEOMED ENTERAL ONLY EXTENSION SETKNT2010-08-03
710491892560396K082238NEOMED POLYURETHANE FEEDING TUBEFPD2008-10-01
710491449893713K072997NEOMED URINARY CATHETEREZD2007-12-19
710491939169306K072881NEOMED Enteral FEEDING TUBEFPD2008-01-09
604811190579028K061258TRABECTOME HIGH FREQUENCY GENERATOR/LPGEI2006-05-18
604811584533065K050322MICROTEK EQUIPMENT DRAPESKKX2005-05-17
604811138086257K040584NMX-1000GEI2004-04-22
604811606901989K040239SUPRAFLOW CONSOLEBTA2004-02-17
604811036042148
710491198686485
604811694880447
710491946368971
710491981847326
710492056306782
2005151022068062
2005151029126925
2005151073972566
2005151150176908
2005151154052052
2005151187247519
2005151392751501
2005151412838713
2005151565679764
2005151716857163
2005151747038673
2005151761969068
2005151764450871
2005151836748371
2005151966462147
2005152025565323

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LMH92017-10-19
MOZ82017-08-29
PNR32019-04-30
LBI22017-10-06
KNT22012-04-19
FPD22008-10-01
GEI22006-05-18
FMF12012-09-20
EZD12007-12-19
KKX12005-05-17
BTA12004-02-17

PMN#

KIM

2011-12-20

NEOMEDIC INTERNATIONAL S.L.

GUDID#

Goniotome +I/A Handpiece - The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plastic outer shell (~1.5 cm diameter and ~13 cm length), a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber), irrigation and aspiration tubing extruded from DEHP-free PVC (~15 cm length) terminated with polycarbonate luer connectors. The diameter of the probe insertable into the eye is ~1.1 mm. The tip of the probe features a pointed footplate tip and dual sharpened edges fabricated of stainless steel.The Handpiece is intended to be used in ophthalmic surgery to manually cut Trabecular Meshwork (TM) in adult and infantile patients.The Handpiece can be connected to a suitable ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration of balanced salt solution (BSS) while the procedure is being performed.

NEOMEDIX CORPORATION

2019-07-17

Goniotome Handpiece - The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plastic outer shell (~1.5 cm diameter and ~13 cm length), and a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber). The diameter of the probe insertable into the eye is ~1.1 mm. The tip of the probe features a pointed footplate tip and dual sharpened edges fabricated of stainless steel.The Handpiece is intended to be used in ophthalmic surgery to manually cut Trabecular Meshwork (TM) in adult and infantile patients.

NEOMEDIX CORPORATION

2019-07-17

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