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
163153–163176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1981
FOAM WEDGE
K812482 · LDQ
Maddak, Inc.
General & Plastic Surgery · 24d
Cleared Sep 24, 1981
BOSCH HEARING INSTRUMENTS
K812503 · CCQ
Retlif, Inc.
Anesthesiology · 23d
Cleared Sep 24, 1981
THE ARTHROFILE
K812506 · HTR
Dyonics, Inc.
General & Plastic Surgery · 23d
Cleared Sep 24, 1981
CORDIA IM
K812540 · KTN
Cordis Corp.
Immunology · 20d
Cleared Sep 24, 1981
TOMAC STERILE DISP. LAP SPONGE
K812554 · GDY
American Convertors Div., American...
General & Plastic Surgery · 16d
Cleared Sep 24, 1981
HDL CHOLESTEROL REAGENT
K812574 · LBR
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Sep 24, 1981
BOVINE CHEMISTRY CONTROL I.X. & II.X.
K812583 · JJY
American Dade
Chemistry · 14d
Cleared Sep 24, 1981
ULTRA CHEM E-TRIG #65024
K812589 · CDT
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
ULTRA ZYME PLUS LDH #64950, 65038 & 39
K812590 · CFJ
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
ULTRA ZYME PLUS GPT, #64956, 65035 & 36
K812591 · CKA
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
ULTRA ZYME PLUS GOT #64953, 65033 & 34
K812592 · CIT
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
DELTA-A.V. FISTULA CANNULATION SET
K812621 · FIE
Amisco Trading Corp.
Gastroenterology & Urology · 9d
Cleared Sep 24, 1981
HEMODIALYSIS VENOUS & ARTERIAL SET
K812622 · FKH
Amisco Trading Corp.
Gastroenterology & Urology · 9d
Cleared Sep 23, 1981
CYBERLITH IX IMPLANTABLE PULSE GENERATOR
K801337 · DXY
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
TELEMETRY DECODER
K801339 · DXY
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
BLOOD FREEZING BAG
K810500 · KSR
Delmed, Inc.
Hematology · 211d
Cleared Sep 23, 1981
ALPHA PLASTIC PLASMA BOTTLE
K810897 · KSR
Alpha Therapeutic Corp.
Hematology · 173d
Cleared Sep 23, 1981
MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY
K811464 · DXH
Intermedics, Inc.
Cardiovascular · 120d
Cleared Sep 23, 1981
CYTOMEGELISA TEST KIT
K812123
M.A. Bioproducts
Microbiology · 58d
Cleared Sep 23, 1981
EM-X
K812222 · KSG
Biological Corp. of America
Immunology · 47d
Cleared Sep 23, 1981
SKIN ADHESIVE-50XX
K812249 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 43d
Cleared Sep 23, 1981
PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY
K812338 · CBT
Terumo Medical Corp.
Anesthesiology · 36d
Cleared Sep 23, 1981
TITERTEK MICROPLATE INCUBATOR
K812340 · JTQ
Flow Laboratories, Inc.
Chemistry · 36d
Cleared Sep 23, 1981
BECKMAN R.PR CONTROL SERUM SET
K812425 · GMP
Beckman Instruments, Inc.
Hematology · 30d