510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851654Substantially Equivalent

Omnimed Clamp

Omni Intl., Inc., Palm Springs CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851654 is the FDA 510(k) clearance record for OMNIMED CLAMP, a class I device, cleared for Omni Intl., Inc. on under FDA product code HXD (Clamp). FDA records list 12 510(k) clearances for Omni Intl., Inc., from to . As of , FDA records show no recalls naming K851654.

Clearance record

Decision date
Received
(39 days to decision)
Product code
HXD Clamp
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Omni Intl., Inc. 870 Research Dr., Palm Springs CA
Third party review
No

Clearances, product code HXD

Trailing 12 months

FDA records hold no clearances under product code HXD in the trailing twelve months.

FDA records show no clearances under product code HXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HXD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260