Conkin Surgical Instruments , Ltd. FDA Record

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

  • Latest inspection VAI · Nov 4, 2015
  • Last warning letter 2015
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Jan 12, 2015
510(k) clearances 1 Latest Jul 9, 1998

Conkin Surgical Instruments , Ltd. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Conkin Surgical Instruments , Ltd., the most recent on Jan 12, 2015.

What these totals cover: FDA records filed under the name "Conkin Surgical Instruments , Ltd." and its spelling variant "Conkin Surgical Instruments".

Latest inspection
Nov 4, 2015 · VAI
Latest 510(k)
Jul 9, 1998

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Reviewing Conkin Surgical Instruments , Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Conkin Surgical Instruments , Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Conkin Surgical Instruments , Ltd. FDA Warning Letters

1 warning letter on Jan 12, 2015.

IssuedSubjectIssuing officeClose-out letter
Jan 12, 2015 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Sep 11, 2014 to Nov 4, 2015.

DateSiteProductClassificationFEI
Nov 4, 2015Vancouver, CanadaDevicesVoluntary Action Indicated (VAI)3006049570
Sep 11, 2014Vancouver, CanadaDevicesOfficial Action Indicated (OAI)3006049570
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 Conkin Surgical Instruments , Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 12, 2015.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other 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.

FacilityLocationInspectionsLatest
FEI 3006049570Vancouver, Canada2Nov 4, 2015

Recent 510(k) clearances

1 510(k) clearance on Jul 9, 1998.

K-NumberDeviceDate
K974801SINGLE CHANNEL BALLOON CANNULAJul 9, 1998

Conkin Surgical Instruments , Ltd. and the FDA: common questions

Has Conkin Surgical Instruments , Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Conkin Surgical Instruments , Ltd.. The most recent is dated Jan 12, 2015.

Has Conkin Surgical Instruments , Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Conkin Surgical Instruments , Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Conkin Surgical Instruments , Ltd.?

The most recent FDA inspection on file ended Nov 4, 2015 at Vancouver, Canada and was classified VAI. FDA has 2 inspections of Conkin Surgical Instruments , Ltd. on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Conkin Surgical Instruments , Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.

Get a free API key

Prefer a PDF? Request a free supplier snapshot.

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.