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Medispec, Ltd.

FDA Regulatory Profile

Medispec, Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Medispec, Ltd." and its spelling variant "Medispec". Records filed under related names are not included; see Related names.

Latest inspection: Nov 25, 2010 · NAI
Latest 510(k): Jan 27, 2023

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	4	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Medispec, Ltd. above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Medi-Spec	Same company group	0	8	0	0	—

Recent FDA inspections

1 inspection on Nov 25, 2010.

Date	Site	Product	Classification	FEI
Nov 25, 2010	Yehud, Israel	Devices	No Action Indicated (NAI)	3002807616

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Medispec, Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 12, 2010.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002807616	Yehud, Israel	1	Nov 25, 2010

Recent 510(k) clearances

4 510(k) clearances from Mar 12, 1998 to Jan 27, 2023.

K-Number	Device	Date
K210166	Omnispec ED1000	Jan 27, 2023
K063504	ECONOLITH EM1000	Mar 9, 2007
K040461	ECONOLITH E3000, MODEL 3000 (SW-6)	May 25, 2004
K974796	LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER	Mar 12, 1998

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