510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843295Substantially Equivalent

Med. Dynamics High Resolution Solid St

MEDLINE INDUSTRIES, LP - Northfield, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843295 is the FDA 510(k) clearance record for MED. DYNAMICS HIGH RESOLUTION SOLID ST, a class I device, cleared for Medline Industries, Inc. on under FDA product code KQM (Camera, Surgical And Accessories). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K843295.

Clearance record

Decision date
Received
(113 days to decision)
Product code
KQM Camera, Surgical And Accessories
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medline Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KQM

Trailing 12 months

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

FDA records show no clearances under product code KQM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQM, 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