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
22993–23016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2019
Bladder Scanner (Models: M2, M2-W, M1, M1-W)
K190769 · IYO
Suzhou Lischka Medtech Co., Ltd.
Radiology · 57d
Cleared May 22, 2019
Erbe ESU Model VIO 3 with Accessories
K190823 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 51d
Cleared May 22, 2019
RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter...
K190902 · DXQ
Wenzhou Renhua Instruments Co., Ltd.
Cardiovascular · 44d
Cleared May 22, 2019
Ambu aScope 4 RhinoLaryngo Slim
K191080 · EOB
Ambu A/S
Ear, Nose, Throat · 28d
Cleared May 21, 2019
IntraLock Lapidus System
K182342 · HWC
Fusion Orthopedics, LLC
Orthopedic · 266d
Cleared May 21, 2019
Solax Powered Wheelchair
K182576 · ITI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 244d
Cleared May 21, 2019
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
K182711 · GWO
Kelyniam Global, Inc.
Neurology · 236d
Cleared May 21, 2019
MAKO 7
K182975 · HIH
Boston Scientific Corporation
Obstetrics & Gynecology · 208d
Cleared May 21, 2019
ET IV SA Dental Implants
K183242 · DZE
Hiossen, Inc.
Dental · 181d
Cleared May 21, 2019
Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen...
K183646 · QAQ
Edwards Lifeciences, LLC
Cardiovascular · 146d
Cleared May 21, 2019
Smith & Nephew Tablet Application
K190367 · QGY
Smith & Nephew
General & Plastic Surgery · 95d
Cleared May 20, 2019
OnSite Waste Sharps Container
K182235 · MMK
Bluestone Medical, Inc.
General Hospital · 276d
Cleared May 20, 2019
VersaCross Transseptal Sheath
K183655 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 144d
Cleared May 20, 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
K190134 · DXN
Health & Life Co., Ltd.
Cardiovascular · 112d
Cleared May 20, 2019
Aperio AT2 DX System
K190332 · PSY
Leica Biosystems Imaging, Inc.
Pathology · 95d
Cleared May 19, 2019
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire,...
K190125 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 111d
Cleared May 18, 2019
QIAstat-Dx Respiratory Panel
K183597 · OCC
QIAGEN GmbH
Microbiology · 148d
Cleared May 17, 2019
SD Abutment
K173570 · NHA
Surgident Co., Ltd.
Dental · 543d
Cleared May 17, 2019
Cook Unimpregnated Central Venous Catheter
K182252 · FOZ
Cook Incorporated
General Hospital · 270d
Cleared May 17, 2019
CardioGard Emboli Protection Cannula
K182302 · DWF
Cardiogard Medical, Ltd.
Cardiovascular · 266d
Cleared May 17, 2019
WiZARD 310/320 Series CPAP Mask
K182394 · BZD
Apex Medical Corp.
Anesthesiology · 255d
Cleared May 17, 2019
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part...
K183035 · LJE
Cook Incorporated
Gastroenterology & Urology · 197d
Cleared May 17, 2019
Delta Xtend Reverse Shoulder System
K183077 · PHX
Depuy(Ireland)
Orthopedic · 193d
Cleared May 17, 2019
Navigation Enabled Instruments
K183381 · OLO
Stryker
Orthopedic · 162d