Ash Medical Systems, Inc. FDA Record

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

Ash Medical Systems, Inc. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ash Medical Systems, Inc." is on file.

What these totals cover: FDA records filed under the name "Ash Medical Systems, Inc." and its spelling variant "Ash Medical Systems".

Latest 510(k)
Apr 8, 1988

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

3 510(k) clearances from Dec 11, 1986 to Apr 8, 1988.

K-NumberDeviceDate
K874137MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CARApr 8, 1988
K870270MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.Feb 25, 1987
K864179BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTRDec 11, 1986

Ash Medical Systems, Inc. and the FDA: common questions

Has Ash Medical Systems, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Ash Medical Systems, Inc." 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 Ash Medical Systems, Inc. received an FDA Form 483?

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

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