510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medinol Ltd.

Jerusalem, IL

MEDINOL LTD. appears in FDA device records in Jerusalem, IL. FDA records list 6 510(k) clearances between and , 96 PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
96
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 6 510(k) clearances for Medinol Ltd. between 1998 and 2018. The busiest year on record is 1998, with 1. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medinol Ltd., by decision year
YearClearances
19981
20001
20091
20161
20171
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K173581Gallant PTCA Dilatation CatheterLOXSubstantially Equivalent
K162434NC Gallant PTCA CatheterLOXSubstantially Equivalent
K150487X-Suit NIR Biliary Metallic StentFGEUnknown
K081956MEDINOL X-SUIT NIR BILIARY METALLIC STENTFGEUnknown
K002130NIR BILIARY STENTFGEUnknown
K973171NIR BILIARY STENTFGESubstantially Equivalent

Registered establishments

FDA registered establishments for Medinol Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30030841713003182398MEDINOL LTD.8 Hartom Street Beck Tech Bldg. Har Hotzvim B,, Jerusalem 9777508 IL2026
97102843003084171MEDINOL LTD.KIRYAT ATIDIM, BLDG. 8, TEL-AVIV Tel Aviv 6158101 IL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain