FDA.reportPublic FDA data

IZI MEDICAL PRODUCTS LLC

Matched from indexed company URL: IZI MEDICAL PRODUCTS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11231691000123143IZI MEDICAL PRODUCTS LLC1Y2026-01-015 Easter Ct Ste J Owings Mills MD US 21117

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
EBI2150070X-Seed - 1.15mm x 5mm X-SEED Single Pack Loose9014327202visicoil@iba-group.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
836651608064725K991319RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALSIYE1999-09-21
836651676768644K973565QUICK-CARE BIOPSY NEEDLEKNW1997-11-03
836651404360608K964972SHADOWFORMKPQ1997-05-05
836651921656056K200763Osteo-site Vertebral BalloonHRX2020-08-12
836651284184521K191012Navigated Pedicle Access KitOLO2019-08-07
836651461191345K170008Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle SetKNW2017-02-28
836651387949908K162265CushionCast Moldable CushionsIYE2016-11-15
836651144775167K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)IYE2017-04-28
836651931071147K143241MDT Navigable Brain Biopsy CannulaHAW2015-04-13
836651642407007K142344DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation SystemHAW2015-03-20
836651498158178K141141KIVA VCF TREATMENT SYSTEMNDN2014-08-14
836651252118975K140705NAVIGABLE BRAIN BIOPSY CANNULA SETHAW2014-12-05
836651646183417K132124KLARITY VACUUM BAG, KLARITY MOLD CUSHIONIYE2013-11-01
836651249977086K120859PRE-LOADED GOLD VISICOIL CK MARKERKXK2012-04-19
836651994164774K103449BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERSKXK2011-02-25
836651912891248K103433F20NDN2011-01-03
836651813221978K080873OPACITY + BONE CEMENTNDN2008-08-28
836651902302267K070305PRE-LOADED VISICOILIYE2007-03-07
836651276778902K070293BENVENUE VCF OSTEO COIL SYSTEMOCJ2007-07-10
836651415007225K043593SPINE-FIX BIOMIMETIC BONE CEMENTNDN2006-03-17
836651548859923K042691VERTEFIX VERTEBROPLASTY PROCEDURE SETNDN2005-11-08
836651071815222K022708KLARITYIYE2002-11-12
836651797582064K022074SPHERZHAW2002-08-13
836651813805891K014022MRI LINE MARKERIYE2002-03-04
836651079363426
836651274972369
836651519962911
836651599773216
836651845746757

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE72017-04-28
NDN52014-08-14
HAW42015-04-13
KNW22017-02-28
KXK22012-04-19
HRX12020-08-12
OLO12019-08-07
OCJ12007-07-10
KPQ11997-05-05

PMN#

EMBRACE

2010-09-15

IZI MEDICAL PRODUCTS INC.

GUDID#

80 records. Showing 1-40. Next