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
20881–20904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2019
Revitalair 430F
K171899 · CBF
Oxavita Srl
Anesthesiology · 879d
Cleared Nov 22, 2019
Applied Medical Laparoscopic Linear Cutter
K190331 · GDW
Applied Medical Resources Corporation
General & Plastic Surgery · 281d
Cleared Nov 22, 2019
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
K190512 · FDI
Intelligent Endoscopy
Gastroenterology & Urology · 266d
Cleared Nov 22, 2019
Color Liquid, Vita Liquid
K190518 · EIH
Zirkonzahn Srl
Dental · 263d
Cleared Nov 22, 2019
PREVENA PLUS Incision Management System (No Ag)
K190697 · OMP
Kci USA, Inc.
General & Plastic Surgery · 249d
Cleared Nov 22, 2019
Navina Smart System, Navina Classic System
K190977 · KNT
Dentsply Sirona
Gastroenterology & Urology · 221d
Cleared Nov 22, 2019
KLS Martin Individual Patient Solutions
K191028 · JEY
KLS-Martin L.P.
Dental · 218d
Cleared Nov 22, 2019
Healy
K191075 · NUH
Timewaver Production GmbH
Neurology · 213d
Cleared Nov 22, 2019
Parkell Desensitizer Gel
K191103 · EJK
Parkell, Inc.
Dental · 211d
Cleared Nov 22, 2019
3M™ Attest™ Steam Chemical Integrators
K191236 · JOJ
3M Company
General Hospital · 198d
Cleared Nov 22, 2019
MatriStem UBM Pericardial Patch
K191734 · PSQ
Acell, Inc.
Cardiovascular · 147d
Cleared Nov 22, 2019
SMR TT Augmented Glenoid System
K191746 · PHX
Lima Corporate S.P.A.
Orthopedic · 144d
Cleared Nov 22, 2019
Hair Growth System
K191754 · OAP
Kunshan Bella Optical Technology Co.,...
General & Plastic Surgery · 144d
Cleared Nov 22, 2019
BruxZir GT (Gum Tissue) Color
K191903 · EIH
Prismatik Dentalcraft, Inc.
Dental · 129d
Cleared Nov 22, 2019
Trevo Trak 21 Microcatheter
K192122 · DQO
Stryker
Neurology · 108d
Cleared Nov 22, 2019
AMIStem-P Short Neck
K192126 · LZO
Medacta International S.A.
Orthopedic · 108d
Cleared Nov 22, 2019
6450 Ultrasound system
K192157 · IYN
Esaote, S.P.A.
Radiology · 105d
Cleared Nov 22, 2019
Trevo NXT ProVue Retriever
K192207 · POL
Stryker
Neurology · 100d
Cleared Nov 22, 2019
Synergy Platform, Synergy, Infinity, VersaHD
K192242 · IYE
Elekta Limited
Radiology · 95d
Cleared Nov 22, 2019
everX Flow
K192260 · EBF
GC America, Inc.
Dental · 93d
Cleared Nov 22, 2019
LEva Pelvic Digital Health System
K192270 · HIR
Renovia, Inc.
Obstetrics & Gynecology · 92d
Cleared Nov 22, 2019
Navigated Anterolateral Disc Prep Instruments
K192336 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 86d
Cleared Nov 22, 2019
Medsynapse Ris Pacs & Medsynapse VNA
K192508 · LLZ
Medsynaptic Private, Ltd.
Radiology · 71d
Cleared Nov 22, 2019
Spes Medica Subdermal Needle Electrodes
K192603 · GXZ
Spes Medica Srl
Neurology · 63d