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
39745–39768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2013
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
K131377 · KWD
Arthrosurface, Inc.
Orthopedic · 189d
Cleared Nov 19, 2013
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · DZE
Zimmer Dental, Inc.
Dental · 123d
Cleared Nov 19, 2013
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
K132712 · KFM
Medtronic, Inc.
Cardiovascular · 82d
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
K132750 · PFS
Illumina, Inc.
Pathology · 77d
Cleared Nov 19, 2013
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
K132779 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 75d
Cleared Nov 19, 2013
A.L.P.S. CALCANEAL PLATING SYSTEM
K132898 · HRS
Biomet Manufacturing Corp
Orthopedic · 64d
Cleared Nov 19, 2013
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING,...
K133276 · OMP
Kci USA, Inc.
General & Plastic Surgery · 26d
Cleared Nov 18, 2013
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
K131782 · HRS
Aap Implantate AG
Orthopedic · 154d
Cleared Nov 18, 2013
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
K132261 · IZF
Ge Medical Systems, LLC
Radiology · 122d
Cleared Nov 18, 2013
INTEGRITY SPINE CORE SYSTEM
K132718 · ODP
Integrity Spine
Orthopedic · 80d
Cleared Nov 18, 2013
INTEGRA FACET FIXATION SYSTEM
K132859 · MRW
Seaspine, Inc.
Orthopedic · 67d
Cleared Nov 18, 2013
UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
K132968 · PEK
Stryker Spine
Orthopedic · 56d
Cleared Nov 18, 2013
FLOWER ANKLE PLATING SET
K133102 · HRS
Flower Orthopedics Corporation
Orthopedic · 49d
Cleared Nov 15, 2013
SPM-300
K130322 · BZG
Bionet Co., Ltd.
Anesthesiology · 280d
Cleared Nov 15, 2013
AUTOLITH TOUCH
K130368 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 274d
Cleared Nov 15, 2013
ND NABIL DIB INFUSION CATHETER
K130569 · KRA
Translational Research Institute
Cardiovascular · 256d
Cleared Nov 15, 2013
SYMPHONY RF GENERATOR
K130689 · GEI
Thermigen, Inc.
General & Plastic Surgery · 247d
Cleared Nov 15, 2013
NEOVEIL
K130997 · OXC
Gunze Limited
General & Plastic Surgery · 219d
Cleared Nov 15, 2013
MICROCYN SCAR MANAGEMENT HYDROGEL
K131672 · PFP
Oculus Innovative Sciences
General & Plastic Surgery · 162d
Cleared Nov 15, 2013
TENSYN BAND
K131850 · HTN
Dallen Medical, Inc.
Orthopedic · 147d
Cleared Nov 15, 2013
ELECTRONIC PULSE STIMULATOR
K131921 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 142d
Cleared Nov 15, 2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA...
K132376 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 108d
Cleared Nov 15, 2013
VITEK 2 AST ST MEROPENEM
K132507 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared Nov 15, 2013
TRANSGATE GUIDE CATHETER
K132542 · DQY
Stryker Neurovascular
Cardiovascular · 94d