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
19897–19920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2020
NemoCast
K193003 · PNN
Software Nemotec S.L.
Dental · 221d
Cleared Jun 05, 2020
Latex Examination Powder Free Glove, Aloe Vera
K193150 · LZA
Top Glove Sdn. Bhd.
General Hospital · 205d
Cleared Jun 05, 2020
epoc Blood Analysis System
K200107 · CHL
Epocal, Inc.
Chemistry · 140d
Cleared Jun 05, 2020
AxSOS 3 AF System and AxSOS 3 Ti System
K200398 · HRS
Stryker GmbH
Orthopedic · 108d
Cleared Jun 05, 2020
UroLift Advanced Tissue Control (ATC) System
K200441 · PEW
Neotract, Inc.
Gastroenterology & Urology · 102d
Cleared Jun 05, 2020
Signature ONE System
K200615 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 88d
Cleared Jun 05, 2020
Hummingbird Tympanostomy Tube System
K200952 · ETD
Preceptis Medical, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 05, 2020
Voyant Open Fusion Device
K201212 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 31d
Cleared Jun 04, 2020
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K193555 · LZC
Ever Global (Vietnam) Enterprise Corp
General Hospital · 167d
Cleared Jun 04, 2020
bioli lOL Delivery System
K200057 · MSS
Ast Products, Inc.
Ophthalmic · 143d
Cleared Jun 04, 2020
Oxylight
K200104 · GEX
Raja Trading Company, Inc.
General & Plastic Surgery · 139d
Cleared Jun 04, 2020
Journey II XR Knee Instrument
K200227 · JWH
Smith & Nephew, Inc.
Orthopedic · 126d
Cleared Jun 04, 2020
Livongo Blood Glucose Monitoring System (BG1000)
K200277 · NBW
Livongo Health, Inc.
Chemistry · 121d
Cleared Jun 04, 2020
CarboClear® Cervical Plate System
K200883 · KWQ
CarboFix Orthopedics , Ltd.
Orthopedic · 63d
Cleared Jun 04, 2020
HEALIX ADVANCE Anchor with DYNATAPE Suture
K200949 · MBI
Medos International SARL
Orthopedic · 56d
Cleared Jun 04, 2020
t:slim X2 Insulin Pump with Interoperable Technology
K201214 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 30d
Cleared Jun 04, 2020
LZI Tramadol Enzyme Immunoassay
K201223 · DJG
Lin-Zhi International, Inc.
Toxicology · 29d
Cleared Jun 03, 2020
Flap Fixator, Burr Hole Cover
K192310 · GXR
Ossaware Biotech Co., Ltd.
Neurology · 282d
Cleared Jun 03, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K193021 · LNH
Canon Medical Systems Corporation
Radiology · 217d
Cleared Jun 03, 2020
AltiVate Anatomic Canal-Sparing (CS) Shoulder
K193226 · PKC
Encore Medical, L.P.
Orthopedic · 194d
Cleared Jun 03, 2020
Halo™ Single-Loop Snare Kit
K200268 · MMX
Argon Medical Devices, Inc.
Cardiovascular · 121d
Cleared Jun 03, 2020
pREBOA-PRO Catheter
K200459 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 99d
Cleared Jun 03, 2020
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
K200506 · QFO
Chembio Diagnostic Systems
Microbiology · 93d
Cleared Jun 03, 2020
Cardioblate Gemini-s Surgical Ablation Device
K200514 · OCL
Medtronic
Cardiovascular · 93d