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
77209–77232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2002
ENDOANCHOR AND OPENANCHOR
K013749 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 90d
Cleared Feb 11, 2002
DC-3300 LASER DIODE PHOTOCOAGULATOR
K013760 · HQF
Nidek, Inc.
Ophthalmic · 90d
Cleared Feb 11, 2002
SPIROLAB II, MODEL 29
K013812 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 88d
Cleared Feb 11, 2002
JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
K013944 · DWF
Jostra AG
Cardiovascular · 74d
Cleared Feb 11, 2002
CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS
K014048 · GEX
Clinicon Corp.
General & Plastic Surgery · 66d
Cleared Feb 11, 2002
MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K014301 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 42d
Cleared Feb 11, 2002
BRACE EZE
K020009 · EGD
Udent, Inc.
Dental · 40d
Cleared Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · FGE
Cordis Corp.
Gastroenterology & Urology · 34d
Cleared Feb 11, 2002
MODIFICATION TO TRANSSEPTAL INTRODUCER SET
K020090 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 32d
Cleared Feb 11, 2002
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST...
K020138 · KHG
Gds Technology
Hematology · 26d
Cleared Feb 11, 2002
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
K020170 · LPH
Encore Orthopedics, Inc.
Orthopedic · 25d
Cleared Feb 11, 2002
MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
K020281 · NHK
Ventlab Corp.
Anesthesiology · 14d
Cleared Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · DQX
Boston Scientific Corp
Cardiovascular · 14d
Cleared Feb 08, 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 184d
Cleared Feb 08, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · HAW
Smith & Nephew, Inc.
Neurology · 161d
Cleared Feb 08, 2002
OMEGATRAC, MODEL Z105
K013307 · ITI
Teftec Corp.
Physical Medicine · 127d
Cleared Feb 08, 2002
CONCERT RADIOPAQUE BONE CEMENT
K013755 · LOD
Immedica, Inc.
Orthopedic · 87d
Cleared Feb 08, 2002
UROVYSION BLADDER CANCER RECURRENCE KIT
K013785 · MMW
Vysis
Immunology · 86d
Cleared Feb 08, 2002
SYNTHES METALLIC SPIKED WASHERS
K013806 · HTN
Synthes (Usa)
Orthopedic · 85d
Cleared Feb 08, 2002
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
K013864 · GEX
Nidek, Inc.
General & Plastic Surgery · 79d
Cleared Feb 08, 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · LBS
Olympus America, Inc.
Chemistry · 65d
Cleared Feb 08, 2002
CARESIDE APTT
K014028 · GFO
Careside Hemotology, Inc.
Hematology · 64d
Cleared Feb 08, 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS...
K014032 · LBS
Olympus America, Inc.
Chemistry · 64d
Cleared Feb 08, 2002
PYLORITEK VP TEST KIT 5140VP
K014038 · LYR
Serim Research Corp.
Microbiology · 63d