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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143089–143112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1986
HEMOFILTRATION SYSTEM 10
K862716 · FII
Gambro, Inc.
Gastroenterology & Urology · 54d
Cleared Sep 09, 1986
VERSA STIM
K862718 · GXY
Conmedcorp
Neurology · 54d
Cleared Sep 09, 1986
RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
K862909 · BTO
Intl. Medical Devices , Ltd.
Anesthesiology · 40d
Cleared Sep 09, 1986
ALP S.C.E.
K863051 · CJE
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
ALPHA AMYLASE
K863052 · CJA
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
BILIFAST
K863055 · CIG
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CLOROFAST
K863061 · CHJ
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CHOLESTEROL-E FAST (TOTAL)
K863063 · CHH
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
PHOSPHOLIPIDS-E
K863071 · CEQ
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
FOSFOROMETER
K863072 · CEO
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
TOTAL LIPIDS
K863073 · CFD
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
TOTAL PROTEINS
K863074 · CEK
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
UREAFAST
K863076 · CDL
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CREATININE-E
K863078 · JFY
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
URICMETER
K863113 · KNK
J. D. Assoc.
Chemistry · 27d
Cleared Sep 09, 1986
PERITONEAL DIALYSIS CATHETERS
K863128 · FJS
Thermedics, Inc.
Gastroenterology & Urology · 25d
Cleared Sep 09, 1986
MODEL AS-72 ADMINISTRATION SET
K863169 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 22d
Cleared Sep 09, 1986
BLOOD UREA NITROGEN(BUN) PROCEDURE
K863260 · CDQ
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Sep 09, 1986
SURGI-TEK TUBE POSITIONER
K863279
Dermacare Products, Inc.
General & Plastic Surgery · 15d
Cleared Sep 09, 1986
DERMAMARKER
K863280 · FZZ
Dermacare Products, Inc.
General & Plastic Surgery · 15d
Cleared Sep 09, 1986
DISPOSABLE SUCTION CANNULA NO. 902008-000
K863293 · GEA
Lifestream Int'L, Inc.
General & Plastic Surgery · 15d
Cleared Sep 09, 1986
MODIFIED Q50 MEDICAL TREADMILL
K863299 · IOL
Quinton, Inc.
Physical Medicine · 15d
Cleared Sep 09, 1986
GRIP STRENGTH DEVICE (GSD)
K863313 · IKK
Devcom, Inc.
Physical Medicine · 14d
Cleared Sep 08, 1986
TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD
K860830 · LIZ
Technicon Instruments Corp.
Hematology · 187d