Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158761–158784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1983
ENZYMATIC CHOLESTEROL (COLORIMETRIC
K823784 · CHH
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
ALKALINE PHOSPHATASE
K823786 · CJE
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
ABC BRAND
K823793
Beiersdorf, Inc.
Physical Medicine · 29d
Cleared Jan 14, 1983
CONTROL TM 8
K823794 · GLQ
General Diagnostics
Hematology · 29d
Cleared Jan 14, 1983
AMES TDA ETHOSUXIMIDE TEST
K823801 · DLF
Miles Laboratories, Inc.
Chemistry · 28d
Cleared Jan 14, 1983
DIRECT CREATININE PROCEDURE
K823806 · CGX
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
VARIOUS ARM SLING
K823808 · ILI
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
CLAVICAL STRAP
K823809 · IQJ
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
A.C. SPLINT
K823810 · ILI
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
OVERHEAD ARM SLINGS
K823811 · ILE
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
VARIOUS SUPPORTS AND SPLINTS
K823812 · IQI
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
TRACTION ACCESSORIES
K823813 · HST
Danek Medical, Inc.
Neurology · 28d
Cleared Jan 14, 1983
HOT/COLD PACK HOLDERS
K823814 · IME
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
WHEELCHAIR PATIENT RESTRAINTS
K823816 · KNO
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
CAST TOE COVER
K823819 · LGF
Danek Medical, Inc.
Orthopedic · 28d
Cleared Jan 14, 1983
ABDUCTION PILLOW
K823820 · IOZ
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
ANKLE WEIGHTS
K823822 · IOD
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
LUMBOSACRAL SUPPORT
K823823 · IPY
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jan 14, 1983
MEDCARE WOUND CLOSURE TRAY
K823853 · FSM
Medcare Products
General & Plastic Surgery · 23d
Cleared Jan 14, 1983
MEDCARE INCISION & DRAINAGE TRAY
K823855 · FSM
Medcare Products
General & Plastic Surgery · 23d
Cleared Jan 14, 1983
MEDCARE GENERAL PURPOSE TRAY
K823856 · FSM
Medcare Products
General & Plastic Surgery · 23d
Cleared Jan 14, 1983
ADVANCE SYS. EMIT-CAD LIDOCAINE CONTROL
K823865 · LAX
Syva Co.
Chemistry · 22d
Cleared Jan 14, 1983
CHAIN SILENCER
K823873 · KNN
Berkeley Electric Wheelchair Co.
Physical Medicine · 17d
Cleared Jan 14, 1983
BERKELEY BRAKE
K823874 · KNN
Berkeley Electric Wheelchair Co.
Physical Medicine · 17d