Citation Medical Corp. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · Aug 21, 2009
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 12 Latest Jul 14, 1995

Citation Medical Corp. has 0 FDA recalls, 1 inspection, 12 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Citation Medical Corp." is on file.

What these totals cover: FDA records filed under the name "Citation Medical Corp." and its spelling variant "Citation Medical".

Latest inspection
Aug 21, 2009 · NAI
Latest 510(k)
Jul 14, 1995

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances12Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Aug 21, 2009.

DateSiteProductClassificationFEI
Aug 21, 2009Reno, NVDevicesNo Action Indicated (NAI)1000123986
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1000123986Reno, NV1Aug 21, 2009

Recent 510(k) clearances

12 510(k) clearances from May 13, 1991 to Jul 14, 1995.

K-NumberDeviceDate
K951941CITATION MULTIPLE USE DELTA SCOPEJul 14, 1995
K945390CITATION DELTA SCOPEJun 23, 1995
K946290CITATION POWER TOOLJun 15, 1995
K951249CITATION SINUSCOPEApr 10, 1995
K944976BRONCHOSCOPE,NON-RIGIDDec 21, 1994
K940847ENDOSCOPIC PLANTAR FASCIA KITOct 11, 1994
K941563THE BIOPSY TOOLSep 26, 1994
K924494CITSCOPE, BENDABLE -- MODIFICATIONMay 26, 1993
K922144CITSCOPE (MODEL EXTENSIONS)Aug 5, 1992
K921692INTEGRATED VIDEO SYSTEMJul 1, 1992
K912490CITATION MEDICAL SCOPE PROCEDURE PACKAug 16, 1991
K910587MINISCOPEMay 13, 1991

Citation Medical Corp. and the FDA: common questions

Has Citation Medical Corp. received an FDA warning letter?

No FDA warning letter addressed to the name "Citation Medical Corp." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Citation Medical Corp. received an FDA Form 483?

FDA has not published a Form 483 for "Citation Medical Corp." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Citation Medical Corp.?

The most recent FDA inspection on file ended Aug 21, 2009 at Reno, NV and was classified NAI. FDA has 1 inspection of Citation Medical Corp. on file.

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