FDA.reportPublic FDA data

EPIMED INTERNATIONAL, INC.

Matched from indexed company URL: Epimed International

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13162971316297EPIMED INTERNATIONAL, INC.1N2026-01-01141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK JOHNSTOWN NY US 12095
16430591643059Epimed International, Inc.1Y2026-01-0113958 Diplomat Drive Dallas TX US 75234

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
00818788021014Epimed - E-Kath 19g x 12"+1(800)866-3342customerservice@epimed.com
00818788023223Epimed - RF Cobra Injector Cannula 22g 5cm w/ 5mm Coudé® Active Tip+1(800)866-3342customerservice@epimed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1704141715384198K981329FETH-R-KATHBSO1998-08-26
19261715384198K981329FETH-R-KATHBSO1998-08-26
1704141677255350K954584RACZ EPIDURAL CATHETERBSO1996-10-08
19261677255350K954584RACZ EPIDURAL CATHETERBSO1996-10-08
1704141130683999K854334PAINBLOCKER WA5000GXH1986-04-30
19261130683999K854334PAINBLOCKER WA5000GXH1986-04-30
19261963835321K232632Racz Neurostat RF GeneratorGXD2024-05-24
1704141963835321K232632Racz Neurostat RF GeneratorGXD2024-05-24
19261977524451K200624Percutaneous IntroducerBSO2020-04-27
1704141977524451K200624Percutaneous IntroducerBSO2020-04-27
19261278537001K190256Rulo Radiofrequency Lesion ProbeGXI2019-03-08
1704141278537001K190256Rulo Radiofrequency Lesion ProbeGXI2019-03-08
19261240282683K133316SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)BSO2014-05-28
1704141240282683K133316SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)BSO2014-05-28
19261778671705K072005RK EPIDURAL NEEDLEBSP2008-02-07
1704141778671705K072005RK EPIDURAL NEEDLEBSP2008-02-07
1704141716921680K053318RX EPIDURAL NEEDLEBSP2006-02-17
19261716921680K053318RX EPIDURAL NEEDLEBSP2006-02-17
19262042254995K051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837MIA2005-08-22
1704142042254995K051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837MIA2005-08-22
19261350723606K051171STINGRAY EPIDURAL CATHETER CONNECTORCAZ2005-08-26
1704141350723606K051171STINGRAY EPIDURAL CATHETER CONNECTORCAZ2005-08-26
1704141251954503K043467FLEXIBLE SPINAL NEEDLEBSP2005-03-31
19261251954503K043467FLEXIBLE SPINAL NEEDLEBSP2005-03-31
19261668403651K041843PENCIL POINT NEEDLEBSP2004-08-24
1704141668403651K041843PENCIL POINT NEEDLEBSP2004-08-24
1704141354828105K041021RF INTRODUCTION CANNULAGXI2004-09-16
19261354828105K041021RF INTRODUCTION CANNULAGXI2004-09-16
1704141451087578K030562TUOHY EPIDURAL NEEDLEBSP2003-04-03
19261451087578K030562TUOHY EPIDURAL NEEDLEBSP2003-04-03
1704141490349307K023140VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124BSO2003-08-15
19261490349307K023140VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124BSO2003-08-15
19261205918489K022029QUINCKE SPINAL NEEDLEBSP2002-07-30
1704141205918489K022029QUINCKE SPINAL NEEDLEBSP2002-07-30
1704141490767766K020926EXTENSION SET, MODELS 1911-512FPA2002-07-12
19261490767766K020926EXTENSION SET, MODELS 1911-512FPA2002-07-12
19261599468338
1704141752842263
19261752842263
19261791048381

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BSP122008-02-07
BSO102020-04-27
GXI42019-03-08
GXD22024-05-24
CAZ22005-08-26
MIA22005-08-22
FPA22002-07-12
GXH21986-04-30

PMN#

GUDID#

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