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
162481–162504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1981
A-1 IN-HOME PREGNANCY TEST
K813272 · LCX
C.F. Medical, Inc.
Chemistry · 27d
Cleared Dec 17, 1981
NEIA TRANSFERRIN ENZYMEIMMUNOASSAY
K813288 · DDG
New England Immunology Assoc.
Immunology · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL I
K813293 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL II
K813294 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL III
K813295 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
RA-80 POSITIVE CONTROL
K813309 · DHR
Sun-Kit
Immunology · 23d
Cleared Dec 17, 1981
NO-HOIL COMBOSTAT II KIT
K813310 · CDD
Ria Products, Inc.
Chemistry · 23d
Cleared Dec 17, 1981
MINI-SHAKER
K813318 · JRQ
Dynatech Corp.
Chemistry · 23d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL I
K813321 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
K813322 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Dec 14, 1981
RADIATION STERILIZATION FOR NEEDLE CNTR
K812444 · GAB
Devon Industries, Inc.
Radiology · 108d
Cleared Dec 14, 1981
TERUMO HOLLOW OXYGENATOR CIRCUIT
K812659 · DTM
Terumo Medical Corp.
Cardiovascular · 87d
Cleared Dec 14, 1981
TERUMO HOLLOW FIBER OXYGENATOR
K812660 · DTZ
Terumo Medical Corp.
Cardiovascular · 87d
Cleared Dec 14, 1981
HYGIENTIST
K812909 · ELC
Fibra Sonics, Inc.
Dental · 56d
Cleared Dec 14, 1981
BLOOD PRESSURE MONITOR
K812936 · DXN
Amertek
Cardiovascular · 55d
Cleared Dec 14, 1981
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
K813009 · GWJ
Teca, Inc.
Neurology · 48d
Cleared Dec 14, 1981
BOMED-NCCOM
K813020 · DXG
Bomed Medical Mfr., Ltd.
Cardiovascular · 48d
Cleared Dec 14, 1981
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36
K813021 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 48d
Cleared Dec 14, 1981
VALVED SURGICAL ASPIRATORS
K813029 · GCX
Imedix
General Hospital · 47d
Cleared Dec 14, 1981
FLOWGUARD CATHETERS & CANNALAE
K813037 · DWF
Advocacy International, Ltd.
Cardiovascular · 47d
Cleared Dec 14, 1981
VASCULAR PAWS
K813062 · DXC
Sil-Med Corp.
Cardiovascular · 45d
Cleared Dec 14, 1981
DESERET NEOLON SURGICAL GLOVES
K813088 · KGO
Warner-Lambert Co.
General Hospital · 42d
Cleared Dec 14, 1981
PRESSURE INFUSION PUMP
K813105 · KZD
Calbio, Inc.
General Hospital · 41d
Cleared Dec 14, 1981
MICRO TRANSDUCER CATHETERS
K813125 · DRE
Honeywell, Inc.
Cardiovascular · 40d