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
57817–57840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2007
FLASHLITE REBEL*
K073518 · EBZ
Discus Dental, Inc.
Dental · 6d
Cleared Dec 19, 2007
AMSURE BLADDER IRRIGATION SET
K070873 · LJH
Amsino Intl., Inc.
Gastroenterology & Urology · 265d
Cleared Dec 19, 2007
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
K071210 · LKO
Biomedical Diagnostics (Bmd) SA
Immunology · 232d
Cleared Dec 19, 2007
ARC SURGICAL BIOTRAK PIN SYSTEM
K071616 · HTY
Arc Surgical, LLC
Orthopedic · 189d
Cleared Dec 19, 2007
DUAL SHOT ALPHA
K071691 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 182d
Cleared Dec 19, 2007
PF4 IGG
K071781 · LCO
Genetic Testing Institute
Hematology · 170d
Cleared Dec 19, 2007
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
K072078 · JZG
Biokit, S.A.
Immunology · 142d
Cleared Dec 19, 2007
OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
K072168 · NGX
Well-Life Healthcare Limited
Physical Medicine · 135d
Cleared Dec 19, 2007
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT),...
K072466 · FLE
Scican , Ltd.
General Hospital · 106d
Cleared Dec 19, 2007
BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD
K072478 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 106d
Cleared Dec 19, 2007
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
K072547 · OEH
Idaho Technology, Inc.
Microbiology · 100d
Cleared Dec 19, 2007
PERFORMAX TOTAL FACE MASK
K072592 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 96d
Cleared Dec 19, 2007
PATIENT CONTOURED MESH-PEEK (PCM-P)
K072707 · GXN
KLS-Martin L.P.
Neurology · 85d
Cleared Dec 19, 2007
NON-IV ADAPTER FOR INFANT NG TUBE
K072756 · KNT
Promedic, Inc.
Gastroenterology & Urology · 83d
Cleared Dec 19, 2007
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
K072810 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 79d
Cleared Dec 19, 2007
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
K072951 · OTP
Sofradim Production
Obstetrics & Gynecology · 62d
Cleared Dec 19, 2007
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
K072961 · JDX
Sra Developments, Ltd.
Orthopedic · 61d
Cleared Dec 19, 2007
NEOMED URINARY CATHETER
K072997 · EZD
Neomed, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 19, 2007
ECLIPSE TREATMENT PLANNING SYSTEM
K073020 · MUJ
Varian Medical Systems, Inc.
Radiology · 54d
Cleared Dec 19, 2007
DENTIN DESENSITIZER AGENT
K073117 · LBH
Dentsply Intl., Inc.
Dental · 44d
Cleared Dec 19, 2007
MASTER-VU
K073196 · IYO
Sonomed, Inc.
Radiology · 36d
Cleared Dec 19, 2007
NIO 5MP, MODEL MDNG-5121
K073205 · LLZ
Barcoview, Medical Imaging Systems
Radiology · 36d
Cleared Dec 19, 2007
THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT
K073220 · OBR
Prestige Brands, Inc.
Dental · 34d
Cleared Dec 19, 2007
COLOR LCD MONITOR, FLEXSCAN MX300W
K073340 · LLZ
Eizo Nanao Corporation
Radiology · 21d