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
139249–139272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1987
KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE
K871984 · LMD
Eastman Kodak Company
Radiology · 82d
Cleared Aug 12, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871992 · DXY
Telectronics, Inc.
Cardiovascular · 78d
Cleared Aug 12, 1987
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
K871994 · LLL
Behring Diagnostics, Inc.
Immunology · 78d
Cleared Aug 12, 1987
K AND D HOME TRACT
K872121 · HST
Joseph A. Kott, M.D.
Neurology · 77d
Cleared Aug 12, 1987
I.S.G. 3DMV WORKSTATION
K872150 · JAK
I.S.G. Technologies, Inc.
Radiology · 69d
Cleared Aug 12, 1987
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · DWF
Shiley, Inc.
Cardiovascular · 69d
Cleared Aug 12, 1987
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161 · DTL
Shiley, Inc.
Cardiovascular · 69d
Cleared Aug 12, 1987
DOUBLE LUMEN CATHETER
K872248 · DQO
Cordis Corp.
Cardiovascular · 61d
Cleared Aug 12, 1987
DS-7 NUCLEAR MEDICINE GAMMA CAMERA
K872297 · IYX
Sopha Medical Systems, Inc.
Radiology · 57d
Cleared Aug 12, 1987
BC 1400 HAND POSITIONER
K872316 · KPR
Instrumentation Industries, Inc.
Radiology · 56d
Cleared Aug 12, 1987
BC 1800 FINGER POSITIONER
K872317 · KPR
Instrumentation Industries, Inc.
Radiology · 56d
Cleared Aug 12, 1987
GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT
K872325 · JTW
Technology Management & Marketing, Inc.
Microbiology · 56d
Cleared Aug 12, 1987
POWER-AID INDEPENDENT X-RAY POWER SOURCE
K872445 · IZO
Advanced Instrument Development, Inc.
Radiology · 50d
Cleared Aug 12, 1987
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
K872485 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 51d
Cleared Aug 12, 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800 · DEW
Abbott Laboratories
Immunology · 28d
Cleared Aug 12, 1987
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
K872834 · CZJ
Helena Laboratories
Immunology · 26d
Cleared Aug 12, 1987
ACCULITE
K872841 · IWE
Medical Alignment Systems
Radiology · 23d
Cleared Aug 12, 1987
A2J MZ 44 LASER LIGHT FOR POSITIONING
K872894 · IWE
Prometex, Inc.
Radiology · 20d
Cleared Aug 12, 1987
IMMUNO/SLE
K872910 · DHC
Immunostics Co., Inc.
Immunology · 19d
Cleared Aug 11, 1987
AMEBIASIS ELISA TEST KIT
K870318 · KHW
Lmd Laboratories
Microbiology · 195d
Cleared Aug 11, 1987
QUANTASCOPE
K870442 · DXR
Vital Science Corp.
Cardiovascular · 189d
Cleared Aug 11, 1987
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
K871869 · EGJ
Life-Tech Intl., Inc.
Physical Medicine · 90d
Cleared Aug 11, 1987
PLAYTONE AUDIOMETER
K872042 · EWO
Sensory Aids Corp.
Ear, Nose, Throat · 76d
Cleared Aug 11, 1987
SIEMENS SILICONE IMPRESSION MATERIAL
K872152 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 68d