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

Filters: Cleared only ×
175,820 results
25921–25944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2018
VIVIX-S 1717V
K181003 · MQB
Vieworks Co., Ltd.
Radiology · 29d
Cleared May 15, 2018
ICEfx Cryoablation System
K181153 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 14d
Cleared May 14, 2018
Dentium Implantium & SuperLine Prosthetics
K172640 · NHA
Dentium Co., Ltd.
Dental · 255d
Cleared May 14, 2018
RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
K173279 · FMI
Myco Medical Supplies, Inc.
General Hospital · 213d
Cleared May 14, 2018
Pristina Serena
K173576 · MUE
Ge Healthcare
Radiology · 175d
Cleared May 14, 2018
Disposable Biopsy Valve
K173758 · OCX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 154d
Cleared May 14, 2018
Ventripoint Medical System Plus (VMS+)
K173810 · IYN
Ventripoint Diagnostics , Ltd.
Radiology · 150d
Cleared May 14, 2018
SeaSpine Daytona Small Stature Spinal System
K180686 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 60d
Cleared May 14, 2018
Clarius Ultrasound Scanner
K180799 · IYN
Clarius Mobile Health Corp.
Radiology · 48d
Cleared May 11, 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve,...
K170663 · BTM
Foremount Enterprise Co., Ltd.
Anesthesiology · 431d
Cleared CT May 11, 2018
µCor Heart Failure and Arrhythmia Management System
K172510 · MHX
Zoll Manufacturing Corporation
Cardiovascular · 263d
Cleared May 11, 2018
SeaSpine Navigation System
K172517 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 263d
Cleared May 11, 2018
ALGS6 Ag Alginate Wound Dressing
K172570 · FRO
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery · 256d
Cleared CT May 11, 2018
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
K172625 · DQA
Nonin Medical, Inc.
Anesthesiology · 252d
Cleared May 11, 2018
HealthBeacon HB2 Sharps Bin
K172719 · MMK
Healthbeacon, Ltd.
General Hospital · 245d
Cleared May 11, 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · FRN
Baxter Healthcare Corporation
General Hospital · 224d
Cleared May 11, 2018
EmbryoScope+
K173264 · MQG
Vitrolife A/S
Obstetrics & Gynecology · 212d
Cleared May 11, 2018
GSI Corti
K180287 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 99d
Cleared May 11, 2018
Light based hair removal device
K180383 · OHT
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 88d
Cleared May 11, 2018
Infrared Body Thermometer
K180385 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 88d
Cleared May 11, 2018
HS40 Diagnostic Ultrasound System
K180409 · IYN
Samsung Medison Co., Ltd.
Radiology · 86d
Cleared May 11, 2018
Collagentex Rx-6
K180585 · NHN
Tanses Technologies, Inc.
Physical Medicine · 67d
Cleared May 11, 2018
LineUp
K180727 · JAK
Curvebeam, LLC
Radiology · 52d
Cleared May 11, 2018
Cytal Wound Particulate
K180776 · KGN
Acell, Inc.
General & Plastic Surgery · 49d