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
48769–48792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2010
IBED WIRELESS WITH IBED AWARENESS
K103536 · FNL
Stryker Corporation
General Hospital · 15d
Cleared Dec 15, 2010
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL...
K100060 · KHS
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 338d
Cleared Dec 15, 2010
SPECIALTY ASSAYED CONTROL-2
K100103 · GGC
Helena Laboratories
Hematology · 336d
Cleared Dec 15, 2010
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2,...
K100525 · CGA
Seppim S.A.S.
Chemistry · 294d
Cleared Dec 15, 2010
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01
K100999 · DHB
Phadia AB
Immunology · 247d
Cleared Dec 15, 2010
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
K101012 · DQA
Taidoc Technology Corporation
Anesthesiology · 247d
Cleared Dec 15, 2010
ACTIVON TULLE
K101118 · FRO
Calidad Solutions, Inc.
General & Plastic Surgery · 238d
Cleared Dec 15, 2010
DEPUY GLOBAL UNITE SHOULDER SYSTEM
K101996 · PHX
Depuy(Ireland)
Orthopedic · 153d
Cleared Dec 15, 2010
CONTOURS LAPIDUS PLATING SYSTEM
K102201 · HRS
Orthofix, Inc.
Orthopedic · 133d
Cleared Dec 15, 2010
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
K102796 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 79d
Cleared Dec 15, 2010
V.A.C. GRANUFOAM SILVER SMALL DRESSING
K102956 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 72d
Cleared Dec 14, 2010
SAFECT MODEL VER 1.0
K100372 · LLZ
Medic Vision Brain Technologies, Ltd.
Radiology · 305d
Cleared Dec 14, 2010
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
K100780 · NEW
Unilene Sac
General & Plastic Surgery · 270d
Cleared Dec 14, 2010
COMFORT STANDING WHEELCHAIR, HERO SERIES
K102734 · IPL
Comfort Orthopedic Co., Ltd.
Physical Medicine · 83d
Cleared Dec 14, 2010
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
K102907 · OUR
Zyga Technology, Inc.
Orthopedic · 74d
Cleared Dec 14, 2010
INBONE TOTAL ANKLE SYSTEM MODEL 200347902
K103374 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Dec 13, 2010
FRONTIER DEVICES NEURO SYSTEM
K100205 · GWO
Folsom Metal Products, Inc.
Neurology · 322d
Cleared Dec 13, 2010
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
K100700 · FPD
Benlan, Inc.
Gastroenterology & Urology · 276d
Cleared Dec 13, 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
K100779 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 269d
Cleared Dec 13, 2010
STRAUMANN CARES BRIDGE
K101465 · NHA
Institut Straumann AG
Dental · 201d
Cleared Dec 13, 2010
TREVAIR CHAIR ADULT
K102061 · IOR
Patmont Motor Werks, Inc.
Physical Medicine · 144d
Cleared Dec 13, 2010
BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS
K102660 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 89d
Cleared Dec 13, 2010
DIGITAL THERMOMETER
K102718 · FLL
International Regulatory Consultants,...
General Hospital · 83d
Cleared Dec 13, 2010
TRABECULAR METAL TIBIAL CONE AUGMENTS
K102896 · MBH
Zimmer Trabecular Metal Technology
Orthopedic · 74d