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
63097–63120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2006
HEMOSIL SYNTHASIL
K060688 · GFO
Instrumentation Laboratory CO
Hematology · 29d
Cleared Apr 13, 2006
MODIFICATION TO XIA 4.5 SPINAL SYSTEM
K060748 · NKB
Stryker Spine
Orthopedic · 23d
Cleared Apr 13, 2006
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
K060777 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 22d
Cleared Apr 13, 2006
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
K060878 · KHJ
Curamedical, BV
Ear, Nose, Throat · 13d
Cleared Apr 13, 2006
S2 RECON NAIL SYSTEM
K060921 · HSB
Howmedica Osteonics Corp.
Orthopedic · 9d
Cleared Apr 12, 2006
PROACT WITH GEL OR PROACT 1
K052243 · JOW
Proact, Inc.
Cardiovascular · 238d
Cleared Apr 12, 2006
NEUROPROBES
K052527 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 212d
Cleared Apr 12, 2006
MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT
K052641 · MQP
Quantum Orthopedics, Inc.
Orthopedic · 198d
Cleared Apr 12, 2006
OMNILINK .035 BILIARY STENT SYSTEM
K053459 · FGE
Guidant Corporation
Gastroenterology & Urology · 120d
Cleared Apr 12, 2006
INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
K060039 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 96d
Cleared Apr 12, 2006
MCKINLEY SATURATION CATHETER
K060119 · FRN
Mckinley Medical, LLC
General Hospital · 85d
Cleared Apr 12, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND...
K060217 · LON
Becton, Dickinson & CO
Microbiology · 75d
Cleared Apr 12, 2006
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K060223 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 72d
Cleared Apr 12, 2006
NUVASIVE SPHERX SYSTEM
K060225 · MNH
Nuvasive, Inc.
Orthopedic · 72d
Cleared Apr 12, 2006
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
K060327 · DQY
Vascular Solutions, Inc.
Cardiovascular · 62d
Cleared Apr 12, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN),...
K060444 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Apr 12, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
K060470 · NBW
Bayer Healthcare
Chemistry · 48d
Cleared Apr 12, 2006
CIDEX ACTIVATED DIALDEHYDE SOLUTION
K060618 · MED
Johnson & Johnson Co.
General Hospital · 35d
Cleared Apr 12, 2006
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
K060729 · DXN
Health & Life Co., Ltd.
Cardiovascular · 26d
Cleared Apr 12, 2006
VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE
K060782 · FQH
Smith & Nephew Wound Management
General Hospital · 21d
Cleared Apr 12, 2006
STRYKER PLATING SYSTEM
K060798 · HRS
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Apr 12, 2006
SYMMETRY BALLOON DILATATION CATHETER
K060959 · LIT
Boston Scientific Corporation
Cardiovascular · 5d
Cleared Apr 12, 2006
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
K060960 · LIT
Boston Scientific Corporation
Cardiovascular · 5d
Cleared Apr 11, 2006
EPICERAM
K052643 · FRO
Ceragenix Corporation
General & Plastic Surgery · 197d