FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
29617–29640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2017
Flex-Thread Clavicle Pin System
K163488 · HSB
Intrafuse, LLC
Orthopedic · 98d
Cleared Mar 20, 2017
CoreCath 2.7S
K170296 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 48d
Cleared Mar 20, 2017
Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm,...
K170539 · KNW
Avitus Orthopaedics, Inc.
Gastroenterology & Urology · 25d
Cleared Mar 17, 2017
Consult Station TS
K153600 · DXN
H4D Sas
Cardiovascular · 457d
Cleared Mar 17, 2017
RnD TE and RnD SE
K161077 · KLE
Apex Dental Materials, Inc.
Dental · 333d
Cleared Mar 17, 2017
OC-FLEX Flexible IntraOral Cannula
K161250 · CCK
Venture Therapeutics, Inc.
Anesthesiology · 318d
Cleared Mar 17, 2017
Noris Medical MBI-2mm Dental Implant System
K162308 · DZE
Noris Medical , Ltd.
Dental · 212d
Cleared Mar 17, 2017
UltraCath Continuous Nerve block Catheter
K162522 · BSO
Teleflexmedical, Inc.
Anesthesiology · 189d
Cleared Mar 17, 2017
OPT-SHIELD AIR, SUPINE
K162562 · DWJ
Bcg Medical, LLC
Cardiovascular · 184d
Cleared Mar 17, 2017
Exam Vue PACS
K162868 · LLZ
Jpi Healthcare Solutions, Inc.
Radiology · 155d
Cleared Mar 17, 2017
Olecranon Plating System
K162898 · HRS
Miami Device Solutions, LLC
Orthopedic · 151d
Cleared Mar 17, 2017
SMARTmatic
K163239 · EFA
Kaltenbach & Voigt GmbH
Dental · 119d
Cleared Mar 17, 2017
Discovery MR750 3.0T
K163331 · LNH
Ge Medical Systems, LLC
Radiology · 109d
Cleared Mar 17, 2017
MAZIC Duro
K163346 · EBF
Vericom Co., Ltd.
Dental · 108d
Cleared Mar 17, 2017
Monarch Airway Clearance System
K163378 · BYI
Hill-Rom Services Pte, Ltd.
Anesthesiology · 106d
Cleared Mar 17, 2017
Elecsys CMV IgM
K163569 · LFZ
Roche Diagnostics
Microbiology · 88d
Cleared Mar 17, 2017
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
K163586 · PIF
Trovrx, Inc. Dba Trovita Health Science
Gastroenterology & Urology · 87d
Cleared Mar 17, 2017
Sparkling
K163655 · GEX
Shanghai Wonderful Opto-Electrics...
General & Plastic Surgery · 84d
Cleared Mar 17, 2017
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
K170501 · MAI
Conmed Corporation
Orthopedic · 24d
Cleared Mar 17, 2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K170583 · DTN
Medtronic, Inc.
Cardiovascular · 17d
Cleared Mar 16, 2017
Multi-unit Abutment Plus
K161416 · NHA
Nobel Biocare AB
Dental · 297d
Cleared Mar 16, 2017
U2 Total Knee System E-XPE products
K161705 · JWH
United Orthopedic Corporation
Orthopedic · 269d
Cleared Mar 16, 2017
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK®...
K161840 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 254d
Cleared Mar 16, 2017
JOINIX CANNULAR SYSTEM
K162070 · HRX
Aju Pharm Co., Ltd.
Orthopedic · 232d