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
11785–11808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2022
TorchTM Software
K220630 · LLZ
Voximetry, Incorporated
Radiology · 269d
Cleared Nov 28, 2022
pNOVUS 21 Microcatheter
K221279 · DQO
Phenox, Ltd.
Neurology · 209d
Cleared Nov 28, 2022
T-Line Hernia Mesh
K221556 · FTL
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 181d
Cleared Nov 28, 2022
Aevumed PHANTOM™-LP Suture Anchors
K222363 · MBI
Aevumed, Inc.
Orthopedic · 116d
Cleared Nov 28, 2022
Male Latex Condoms
K222611 · HIS
Suzhou Colour-Way New Material Co., Ltd.
Obstetrics & Gynecology · 90d
Cleared Nov 28, 2022
Aneroid Sphygmomanometer
K222652 · DXQ
Cardicare Company, Ltd.
Cardiovascular · 88d
Cleared Nov 28, 2022
da Vinci E-200 Electrosurgical Generator
K223039 · GEI
Intuitive Surgical
General & Plastic Surgery · 60d
Cleared Nov 28, 2022
Facet Manatee Reusable Lancing Base
K223099 · QRL
Facet Technologies, LLC
General & Plastic Surgery · 59d
Cleared Nov 28, 2022
Momentum® MIS Posterior Spinal Fixation System
K223274 · NKB
Ulrich Medical USA
Orthopedic · 35d
Cleared Nov 27, 2022
Wireless/Wired X-Ray Flat Panel Detectors
K223009 · MQB
Allengers Medical Systems Limited
Radiology · 59d
Cleared Nov 25, 2022
VSI HoloMedicine
K213215 · LLZ
Apoqlar GmbH
Radiology · 422d
Cleared Nov 25, 2022
Powder-Free Latex examination gloves
K222612 · LYY
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 87d
Cleared Nov 25, 2022
DentCare Aligners
K222918 · NXC
Dentcare Dental Lab Pvt , Ltd.
Dental · 60d
Cleared Nov 23, 2022
Closed System Transfer Device
K201460 · ONB
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 904d
Cleared Nov 23, 2022
Glenoid Reconstruction System
K213459 · PHX
Medacta International S.A.
Orthopedic · 392d
Cleared Nov 23, 2022
CuringPen Dental Curing Light
K221152 · EBZ
Changzhou Sifary Medical Technology...
Dental · 217d
Cleared Nov 23, 2022
PainShield MD PLUS
K221210 · PFW
Nanovibronix, Inc.
Physical Medicine · 210d
Cleared Nov 23, 2022
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De)
K221815 · GEI
Baisheng Medical Co., Ltd.
General & Plastic Surgery · 154d
Cleared Nov 23, 2022
Disposable Automatically Retractable Safety Syringes (with detachable needle)
K222452 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 100d
Cleared Nov 23, 2022
EchoGo Heart Failure
K222463 · QUO
Ultromics Limited
Cardiovascular · 100d
Cleared Nov 23, 2022
Nitrile Patient Examination Glove
K222534 · LZA
Jiangxi Jiangxi Zhonghong Pulin...
General Hospital · 93d
Cleared Nov 23, 2022
Ai Ray Dental X-Ray Device
K222569 · EHD
Guilin Woodpecker Medical Instrument...
Radiology · 91d
Cleared Nov 23, 2022
LDE4 Lancing Device
K222656 · QRL
I-Sens, Inc.
General & Plastic Surgery · 82d
Cleared Nov 23, 2022
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics...
K222967 · HWC
Avanti Orthopaedics, Inc.
Orthopedic · 57d