FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161641–161664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 14, 1981
KODAK INTENSIFYING SCREEN 80-175
K813147 · EAM
Eastman Kodak Company
Radiology · 38d
Cleared Dec 14, 1981
ULTRA-WIDE SAFETY SPECTACLE FRAME
K813156 · HQZ
Zee Medical Products Co., Inc.
Ophthalmic · 38d
Cleared Dec 14, 1981
INTERAD WHOLE BODY CT SCANNER
K813162 · JAK
Interad Systems, Inc.
Radiology · 34d
Cleared Dec 14, 1981
VRT TABLE W/INTEGRATING TUBE STAND/ELEV
K813173 · KPR
General Electric Co.
Radiology · 28d
Cleared Dec 14, 1981
TOURNIQUET
K813231 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 27d
Cleared Dec 14, 1981
UNSCENTED MENSTRUAL PADS-MAXI PADS
K813251 · HHD
I.C.D. Industries, Inc.
Obstetrics & Gynecology · 25d