FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9985–10008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2023
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
K223329 · HGX
Guangzhou Yongyi Industrial Co., Ltd.
Obstetrics & Gynecology · 207d
Cleared May 26, 2023
Dark Star Deformity Pedicle Screw System
K223096 · NKB
Republic Spine, LLC
Orthopedic · 238d
Cleared May 26, 2023
Sweden & Martina Surgical Trays
K222640 · KCT
Sweden & Martina S.P.A.
General Hospital · 267d
Cleared May 26, 2023
V-HYADASE
K222606 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 270d
Cleared May 26, 2023
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
K213289 · KGO
Ansell Healthcare Products, LLC
General Hospital · 602d
Cleared May 26, 2023
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent...
K203599 · KTL
Immuno Concepts, N.A. , Ltd.
Immunology · 898d
Cleared May 25, 2023
S-COMP Reform® POCT Navigation Instruments
K231229 · OLO
Precision Spine, Inc.
Orthopedic · 27d
Cleared May 25, 2023
Stingray LP Catheter
K231176 · DQY
Boston Scientific
Cardiovascular · 30d
Cleared May 25, 2023
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for...
K231169 · MLR
Plasmapp Co,., Ltd.
General Hospital · 30d
Cleared May 25, 2023
Saranas Early Bird Bleed Monitoring System
K230273 · QFJ
Saranas, Inc.
Cardiovascular · 114d
Cleared May 25, 2023
Soreal Press, Soreal CAD
K230259 · EIH
Shenzhen Up3D Technology Co., Ltd.
Dental · 114d
Cleared May 25, 2023
BB 8 Sinus Dilation Kit
K230258 · LRC
Excelent, Inc.
Ear, Nose, Throat · 114d
Cleared May 25, 2023
Dentis s-Clean SQ-SL Narrow Implant System
K230246 · NHA
Dentis Co., Ltd.
Dental · 115d
Cleared May 25, 2023
Model 9160 VitaloQUB
K223818 · JEH
Vitalograph (Ireland) , Ltd.
Anesthesiology · 155d
Cleared May 25, 2023
Genesis ACTIVE Implant System
K223814 · DZE
Keystone Dental, Inc.
Dental · 156d
Cleared May 25, 2023
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care...
K223491 · QBS
Ge Medical Systems, LLC
Radiology · 185d
Cleared May 25, 2023
Dental Desensitizer
K222891 · LBH
Guangzhou Beogene Biotech Co., Ltd.
Dental · 244d
Cleared May 25, 2023
Nipro SafeTouch Needle
K222852 · FMI
Nipro Medical Corporation
General Hospital · 246d
Cleared May 25, 2023
KLS Martin LINOS Wrist System
K222624 · HRS
KLS-Martin L.P.
Orthopedic · 267d
Cleared May 25, 2023
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
K222311 · FLL
Circa Scientific, Inc.
Cardiovascular · 297d
Cleared May 25, 2023
Advanced LumFix Spinal Fixation System
K222229 · NKB
CG Bio Co., Ltd.
Orthopedic · 304d
Cleared May 25, 2023
Armis VeriCyn Wound Wash
K220759 · FQH
Armis Biopharma, Inc.
General & Plastic Surgery · 436d
Cleared May 25, 2023
ThermoTK
K213256 · PBX
Zimmer Medizinsysteme GmbH
General & Plastic Surgery · 602d
Cleared May 24, 2023
s-Clean Link Abutment Narrow
K230523 · NHA
Dentis Co., Ltd.
Dental · 86d