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
59833–59856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2007
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND...
K060915 · HCH
Kirwan Surgical Products, Inc.
Neurology · 378d
Cleared Apr 17, 2007
KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138
K062453 · IPF
Kingly Star Intl. Technology Co., Ltd.
Physical Medicine · 238d
Cleared Apr 17, 2007
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL...
K063306 · LCP
Alfa Wassermann, Inc.
Chemistry · 167d
Cleared Apr 17, 2007
LINDE INTEGRATED VALVE (LIV)
K063354 · ECX
Linde Gas Therapeutics
Anesthesiology · 162d
Cleared Apr 17, 2007
CYRTINA SYSTEM
K063842 · EIH
Oratio B.V.
Dental · 112d
Cleared Apr 17, 2007
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K070172 · LSL
Roche Diagnostics Corporation
Microbiology · 89d
Cleared Apr 17, 2007
ULTRAPRO PLUG
K070224 · FTL
Ethicon, Inc.
General & Plastic Surgery · 83d
Cleared Apr 17, 2007
SUTRALENE POLYPROPYLENE SUTURES
K070243 · GAW
Visionary Medical Supplies, Inc.
General & Plastic Surgery · 82d
Cleared Apr 17, 2007
SPI VECTODRILL CERAMIC DRILLS
K070290 · NDP
Thommen Medical AG
Dental · 77d
Cleared Apr 17, 2007
XPERT MRSA
K070462 · NQX
Cepheid
Microbiology · 60d
Cleared Apr 17, 2007
REVOLIX DUO LASER SYSTEM
K070466 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 60d
Cleared Apr 17, 2007
HEALTH MASK
K070467 · OBN
Polar Wrap, LLC
Anesthesiology · 60d
Cleared Apr 17, 2007
INTERSON USB ULTRASOUND PROBE SYSTEM
K070907 · IYO
Regulatory Management Services
Radiology · 15d
Cleared Apr 16, 2007
ODONCER
K062102 · LYC
Teknimed, S.A.
Dental · 266d
Cleared Apr 16, 2007
MEISINGER BENEX, MODEL BE001
K062130 · EMG
Hager& Meisinger GmbH
Dental · 264d
Cleared Apr 16, 2007
MICROBLADE SHAVER AND ACCESSORIES
K063231 · HAE
Baxano, Inc.
Neurology · 173d
Cleared Apr 16, 2007
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED...
K063271 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 168d
Cleared Apr 16, 2007
ABBOTT ARCHITECT HAVAB-M
K063329 · LOL
Abbott Laboratories
Microbiology · 164d
Cleared Apr 16, 2007
INQU
K063359 · MQV
Isto Technologies, Inc.
Orthopedic · 160d
Cleared Apr 16, 2007
DYE MANAGEMENT SYSTEM
K063784 · DQO
Icu Medical, Inc.
Cardiovascular · 116d
Cleared Apr 16, 2007
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K063790 · JEY
Synthes (Usa)
Dental · 115d
Cleared Apr 16, 2007
COLLEAGUE GUARDIAN CONFIGURATION TOOL
K070125 · FRN
Baxter Healthcare Corp
General Hospital · 90d
Cleared Apr 16, 2007
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K070174 · MKZ
Roche Diagnostics Corporation
Microbiology · 88d
Cleared Apr 16, 2007
OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
K070227 · MBI
Arthrocare Corp.
Orthopedic · 82d