FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
20929–20952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2019
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior...
K192281 · MRW
Medos International SARL
Orthopedic · 90d
Cleared Nov 20, 2019
FUJIFILM Endoscope Model EC-760Z-V/L
K192664 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 56d
Cleared Nov 20, 2019
uPMR 790
K192672 · OUO
Shanghai United Imaging Healthcare...
Radiology · 55d
Cleared Nov 20, 2019
TranS1 AxiaLIF Plus System
K192792 · KWQ
Trans1
Orthopedic · 51d
Cleared Nov 20, 2019
Penumbra LP Coil System
K192955 · HCG
Penumbra, Inc.
Neurology · 30d
Cleared Nov 19, 2019
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550,...
K182979 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 389d
Cleared Nov 19, 2019
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
K190816 · LHI
Avenir Performance Europeenne Medical...
General Hospital · 235d
Cleared Nov 19, 2019
RSI-MRI+
K191278 · LLZ
Multimodal Imaging Services...
Radiology · 190d
Cleared Nov 19, 2019
Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal...
K192204 · NUC
Valencia Naturals, Inc.
Obstetrics & Gynecology · 97d
Cleared Nov 19, 2019
TwinScan 808/755 Laser System
K192269 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 90d
Cleared Nov 19, 2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight...
K192292 · OWN
Stryker
General & Plastic Surgery · 88d
Cleared Nov 19, 2019
Dolphin Medical Imaging USB Ultrasound System
K192573 · IYO
Dolphin Medical Imaging, LLC
Radiology · 62d
Cleared Nov 19, 2019
Dannik Laparoscopic Suction Irrigation System
K192643 · GCJ
Dannik
General & Plastic Surgery · 56d
Cleared Nov 18, 2019
JTL-250-01
K182732 · MUU
Jointechlabs, Inc.
General & Plastic Surgery · 416d
Cleared Nov 18, 2019
FluoroCal
K182917 · LBH
Bisco, Inc.
Dental · 395d
Cleared Nov 18, 2019
Digital Thermometer
K183393 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 346d
Cleared Nov 18, 2019
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
K190797 · HIH
Reed Medical (Zhejiang) Co., Ltd.
Obstetrics & Gynecology · 235d
Cleared Nov 18, 2019
CLEARFIL MAJESTY ES Flow
K191980 · EBF
Kuraray Noritake Dental, Inc.
Dental · 117d
Cleared Nov 18, 2019
PolyLock Small Bone Plating System
K192323 · HRS
Fusion Orthopedics, LLC
Orthopedic · 83d
Cleared Nov 18, 2019
Impella CP Introducer
K192769 · DYB
Abiomed, Inc.
Cardiovascular · 49d
Cleared Nov 16, 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K192937 · JOJ
3M Company
General Hospital · 29d
Cleared Nov 15, 2019
ROSA Bracket
K182672 · NJM
Gni Co., Ltd.
Dental · 415d
Cleared Nov 15, 2019
KeyPrint KeySplint Soft
K183598 · MQC
Keystone Industries
Dental · 324d
Cleared Nov 15, 2019
Dornier Ureteral Stent
K190312 · FAD
Dornier Medtech America, Inc.
Gastroenterology & Urology · 276d