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
33457–33480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2015
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
K151378 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 186d
Cleared CT Nov 24, 2015
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens...
K152046 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 124d
Cleared Nov 24, 2015
OsteoCool V-3 RF Ablation System
K152057 · GEI
Baylis Medical Company, Inc.
General & Plastic Surgery · 123d
Cleared Nov 24, 2015
Edwards eSheath Introducer Set
K152225 · DYB
Edwards Lifesciences
Cardiovascular · 109d
Cleared Nov 24, 2015
G3¿ Active Plate® Large Fragment System
K152242 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 106d
Cleared Nov 24, 2015
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
K152838 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Nov 24, 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841 · HWC
Zimmer, Inc.
Orthopedic · 56d
Cleared Nov 24, 2015
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
K152846 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Nov 24, 2015
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
K153150 · PIV
Inova Diagnostics, Inc.
Immunology · 22d
Cleared Nov 23, 2015
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini...
K143669 · MQF
Medgyn Products, Inc.
Obstetrics & Gynecology · 334d
Cleared Nov 23, 2015
Advanced Air System
K143704 · EFB
W&H Dentalwerk Buermoos GmbH
Dental · 329d
Cleared Nov 23, 2015
Revision Femoral Stem
K151739 · LZO
Lima Corporate S.P.A.
Orthopedic · 150d
Cleared Nov 23, 2015
YAMAHACHI PMMA DISKS
K151764 · EBG
Yamahachi Dental Products USA, Inc.
Dental · 146d
Cleared Nov 23, 2015
Ceramax Skin Barrier Cream
K152055 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 122d
Cleared Nov 23, 2015
Ponto bone anchored hearing system
K152067 · MAH
Oticon Medical AB
Ear, Nose, Throat · 122d
Cleared Nov 23, 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
K152272 · FOZ
Arrow International, Inc. (Subsidiary...
General Hospital · 103d
Cleared Nov 23, 2015
Star+ VPS Scannable Impression Material
K152349 · ELW
Danville Materials, LLC
Dental · 95d
Cleared Nov 23, 2015
Wondfo Propoxyphene Urine Test
K152495 · JXN
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 83d
Cleared Nov 23, 2015
Fogarty Occlusion Catheter
K152762 · MJN
Edwards Lifesciences, LLC
Cardiovascular · 60d
Cleared Nov 23, 2015
QuadraSphere Microspheres
K153102 · KRD
Biosphere Medical, S.A.
Neurology · 28d
Cleared Nov 23, 2015
Arthrex Univers Apex, Size 5 Stem
K153115 · KWS
Arthrex, Inc.
Orthopedic · 26d
Cleared Nov 21, 2015
PainKARE
K151034 · NUH
Triowave Technologies
Neurology · 218d
Cleared Nov 20, 2015
ArcCHECK
K142617 · IYE
Sun Nuclear Corporation
Radiology · 430d
Cleared Nov 20, 2015
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
K150514 · LJT
C.R. Bard, Inc.
General Hospital · 266d