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
19681–19704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 2020
Arthrex Eclipse Shoulder Prosthesis System
K201542 · PKC
Arthrex, Inc.
Orthopedic · 29d
Cleared Jul 08, 2020
Intraosseous Fixation System
K201556 · HWC
Extremity Medical, LLC
Orthopedic · 28d
Cleared Jul 08, 2020
ACTIV.A.C. Negative Pressure Wound Therapy System
K201571 · OMP
Kci USA, Inc.
General & Plastic Surgery · 27d
Cleared Jul 08, 2020
CMDR 2C (Multiple Models)
K201575 · IZL
Minxray, Inc.
Radiology · 27d
Cleared Jul 08, 2020
Looking Glass 4K Integrated Visualization System
K201593 · GCJ
Conmed Corporation
General & Plastic Surgery · 26d
Cleared Jul 07, 2020
REXSIN
K200392 · GAM
Sm Eng Co., Ltd.
General & Plastic Surgery · 140d
Cleared Jul 06, 2020
MIS Ti-base Abutment
K191152 · NHA
Dentsply Sirona
Dental · 432d
Cleared Jul 06, 2020
Deep Recon
K193073 · JAK
Shanghai United Imaging Healthcare...
Radiology · 245d
Cleared Jul 06, 2020
RC-Prime Root Canal Preparation Cream
K200330 · KJJ
Pac-Dent, Inc.
Dental · 147d
Cleared Jul 06, 2020
Lollipop BiteBlock
K200652 · IYE
Radtec Medical Devices, Inc.
Radiology · 116d
Cleared Jul 06, 2020
Fujifilm Ultrasonic Processor
K200850 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 97d
Cleared Jul 06, 2020
Arthrex MaxForce MTP Compression Plates and Screws
K201235 · HRS
Arthrex, Inc.
Orthopedic · 60d
Cleared Jul 06, 2020
uMR570
K201540 · LNH
Shanghai United Imaging Healthcare...
Radiology · 27d
Cleared Jul 03, 2020
Oxxiom
K200537 · DQA
True Wearables, Inc.
Anesthesiology · 122d
Cleared Jul 03, 2020
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command...
K200795 · MXD
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jul 02, 2020
IC-WHCD100 (Inspire)
K183471 · NBL
Good Doctors Co., Ltd.
Dental · 566d
Cleared Jul 02, 2020
ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor,...
K192385 · PMS
Ivwatch, LLC
General Hospital · 303d
Cleared Jul 02, 2020
Psoria-Shield AURORA
K192411 · FTC
Psoria-Shield
General & Plastic Surgery · 302d
Cleared Jul 02, 2020
ulrichINJECT CT Motion
K192872 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 268d
Cleared Jul 02, 2020
InferRead Lung CT.AI
K192880 · OEB
Beijing Infervision Technology Co., Ltd.
Radiology · 267d
Cleared Jul 02, 2020
Luna XD Ti Interbody Fusion System
K193172 · MAX
Benvenue Medical, Inc.
Orthopedic · 230d
Cleared Jul 02, 2020
Contour ProtegeAI
K193252 · QKB
Mim Software, Inc.
Radiology · 220d
Cleared Jul 02, 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K193259 · DXQ
Little Doctor Electronic...
Cardiovascular · 219d
Cleared Jul 02, 2020
GC Fuji Triage EP
K193484 · EMA
GC America, Inc.
Dental · 198d