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
70585–70608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2003
BAYER SPECIAL CHEMISTRY CALIBRATORS
K033380 · JIX
Bayer Diagnostics Corp.
Chemistry · 55d
Cleared Dec 16, 2003
EVOLVE
K033551 · DYH
Reliance Orthodontic Products, Inc.
Dental · 36d
Cleared Dec 16, 2003
INSORB ABSORBABLE STAPLE, MODEL SP-B20
K033602 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 32d
Cleared Dec 16, 2003
CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
K033793 · MCW
Rex Medical
Cardiovascular · 11d
Cleared Dec 15, 2003
ACCUSOFT
K032171 · IYE
Direx Systems Corp.
Radiology · 152d
Cleared Dec 15, 2003
EUSOL-C
K032422 · LYX
Al.Chi.Mi.A
Ophthalmic · 132d
Cleared Dec 15, 2003
AEQUALIS SHOULDER FRACTURE SYSTEM
K032679 · KWS
Tornier
Orthopedic · 108d
Cleared Dec 15, 2003
SUBTALAR ARTHRORISIS IMPLANT
K032902 · HWC
Nexa Orthopedics, Inc.
Orthopedic · 89d
Cleared Dec 15, 2003
AUTOMOVE, MODEL AM800
K032955 · IPF
Danmeter A/S
Physical Medicine · 84d
Cleared Dec 15, 2003
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · DKB
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · MNH
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Dec 15, 2003
ZILVER 518 BILIARY STENT
K033348 · FGE
Cook, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 15, 2003
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
K033604 · IYO
Pie Medical
Radiology · 28d
Cleared Dec 15, 2003
PACS SOFTWARE SOLUTION 2003
K033624 · LLZ
Canon USA, Inc.
Radiology · 27d
Cleared Dec 15, 2003
MODIFICATION TO COATEST FACTOR VIII
K033631 · GGP
Instrumentation Laboratory CO
Hematology · 26d
Cleared Dec 15, 2003
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY...
K033701 · MVN
Ciba Vision Corporation
Ophthalmic · 20d
Cleared Dec 15, 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 17d
Cleared Dec 15, 2003
TRIDENT RESECTION ABLATOR
K033748 · GEI
Linvatec Corp.
General & Plastic Surgery · 14d
Cleared Dec 12, 2003
MOTILITY VISUALIZATION SYSTEM
K031169 · FFX
Sierra Scientific Instruments, Inc.
Gastroenterology & Urology · 242d
Cleared Dec 12, 2003
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K031812 · DXC
Vascular Control Systems, Inc.
Radiology · 183d
Cleared Dec 12, 2003
VERTELINK KOBRA SPINAL FIXATION SYSTEM
K032102 · KWQ
Vertelink Corporation
Orthopedic · 157d
Cleared Dec 12, 2003
AMNIOLENS
K032104 · NQB
Bio-Tissue, Inc.
Ophthalmic · 157d
Cleared Dec 12, 2003
CLARITY PET
K032866 · KPS
Shared P.E.T. Imaging, LLC
Radiology · 88d
Cleared Dec 12, 2003
AIACT KIT
K032952 · JBP
Sienco, Inc.
Hematology · 81d