FDA.reportPublic FDA data

MEDINOL LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97102843003084171MEDINOL LTD.1N2026-01-01KIRYAT ATIDIM, BLDG. 8 TEL-AVIV Tel Aviv IL 6158101
30109278483010927848MEDINOL USA INC.1Y2026-01-011845 Vine Cliff Hts Co Spgs CO US 80921

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
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R12US(800) 327-7714GMB-CORDIS-CUSTOMER-SUPPORT@ca
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R12US(800) 327-7714GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R12US(720) 386 5585customerservice@medinol.com
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R15US(800) 327-7714GMB-CORDIS-CUSTOMER-SUPPORT@ca
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R15US(800) 327-7714GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R15US(720) 386 5585customerservice@medinol.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
172931242808008P170008EluNIR™ Ridaforolimus Eluting Coronary Stent SystemNIQ2017-11-28
172931682316884P110004PRESILLION PLUS COCR CORONARY STENT RX SYSTEMMAF2012-04-12
172931554837835K173581Gallant PTCA Dilatation CatheterLOX2018-01-25
172931715143544K162434NC Gallant PTCA CatheterLOX2017-01-19
172932014441856K081956MEDINOL X-SUIT NIR BILIARY METALLIC STENTFGE2009-01-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX22018-01-25
NIQ12017-11-28
MAF12012-04-12
FGE12009-01-09

PMA#

EluNIR™ Ridaforolimus Eluting Coronary Stent System

2022-04-20

Medinol, Ltd.kiryat Atidim, Bldg. 8pob 58165tel Aviv 61581 PMA NumberP170008 Supplement NumberS039 Date Received03/22/2022 Decision Date04/20/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

EluNIR Ridaforolimus Eluting Coronary Stent System

2022-04-19

Medinol, Ltd.kiryat Atidim, Bldg. 8pob 58165tel Aviv 61581 PMA NumberP170008 Supplement NumberS041 Date Received03/22/2022 Decision Date04/19/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

EluNIR TM Ridaforolimus Eluting Coronary Stent System

2022-04-14

Medinol, Ltd.kiryat Atidim, Bldg. 8pob 58165tel Aviv 61581 PMA NumberP170008 Supplement NumberS040 Date Received03/22/2022 Decision Date04/14/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

65 records. Showing 1-40. Next

PMN#

GUDID#

200 records. Showing 1-40. Next