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
52393–52416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2009
MICROFUSE DUAL RATE INFUSER
K091386 · FRN
Numia Medical Technology, LLC
General Hospital · 144d
Cleared Oct 02, 2009
LEFORTE SYSTEM BONE PLATE
K091679 · JEY
Jeil Medical Corporation
Dental · 115d
Cleared Oct 02, 2009
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
K091721 · GEH
New Medical Technologies GmbH
General & Plastic Surgery · 113d
Cleared Oct 02, 2009
SUPER-FINE PEN NEEDLE
K092016 · FMI
Stat Medical Devices, Inc.
General Hospital · 88d
Cleared Oct 02, 2009
EASYCARE TX, TX LINK
K092026 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Oct 02, 2009
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
K092037 · DRT
Hoana Medical, Inc.
Cardiovascular · 88d
Cleared Oct 02, 2009
STELLAR FIDUCIAL MARKER, MODEL GFMIA
K092041 · IYE
Stellar Medical, LLC
Radiology · 87d
Cleared Oct 02, 2009
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K092058 · IYN
Sonosite,Inc.
Radiology · 86d
Cleared Oct 02, 2009
SYNERGY CANNULATED SCREW SYSTEM
K092082 · HWC
Synergy Surgical Technologies, LLC
Orthopedic · 85d
Cleared Oct 02, 2009
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC...
K092111 · EWO
Entomed AB
Ear, Nose, Throat · 80d
Cleared Oct 02, 2009
MODEL SENTINELLA 102
K092471 · IYX
General Equipment For Medical...
Radiology · 52d
Cleared Oct 02, 2009
TSRH SPINAL SYSTEM
K092676 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 31d
Cleared Oct 02, 2009
BAXANO NEURO CHECK DEVICE
K092729 · ETN
Baxano, Inc.
Ear, Nose, Throat · 28d
Cleared Oct 01, 2009
WATERLASE MD
K083927 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 274d
Cleared Oct 01, 2009
CARTO RMT EP NAVIGATION SYSTEM V8
K091789 · DQK
Biosense Webster, Inc.
Cardiovascular · 106d
Cleared Oct 01, 2009
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · JGJ
Abaxis, Inc.
Chemistry · 98d
Cleared Oct 01, 2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
K092056 · HKI
Optomed OY
Ophthalmic · 86d
Cleared Oct 01, 2009
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K092195 · NUV
Cutera, Inc.
General & Plastic Surgery · 72d
Cleared Oct 01, 2009
DYNESYS TOP-LOADING SPINAL SYSTEM
K092234 · NQP
Zimmer Spine, Inc.
Orthopedic · 70d
Cleared Oct 01, 2009
SEAMFREE
K092539 · EBF
Apex Dental Materials, Inc.
Dental · 43d
Cleared Oct 01, 2009
EVISION DATA MANAGEMENT SOFTWARE
K092678 · DQA
Nonin Medical, Inc.
Anesthesiology · 30d
Cleared Oct 01, 2009
GUARDIAN II HEMOSTASIS VALVE
K092711 · DTL
Zerusa Limited
Cardiovascular · 28d
Cleared Oct 01, 2009
IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT
K092867 · ELW
Kettenbach GmbH & Co. KG
Dental · 13d
Cleared Sep 30, 2009
PARCUS PPEK CF INTERFERENCE SCREW
K091093 · HWC
Parcus Medical, LLC
Orthopedic · 167d