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
5449–5472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2024
EMS Sculpt Machine
K232982 · NGX
Shandong Huamei Technology Co., Ltd.
Physical Medicine · 430d
Cleared Nov 25, 2024
Aluna 2
K232588 · BZH
Knox Medical Diagnostics
Anesthesiology · 458d
Cleared Nov 22, 2024
Nooro Body & Foot Stimulator (SM9141, SM9142)
K243334 · NUH
Xf Agencija Limited
Neurology · 29d
Cleared Nov 22, 2024
Giftlife® Single-Step Medium Plus
K242968 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 57d
Cleared Nov 22, 2024
Suction Irrigation Tubing Set
K242927 · GCJ
Advamedix, GmbH
General & Plastic Surgery · 59d
Cleared Nov 22, 2024
Jasmate® Toothpaste
K242913 · LBH
Jasberry Healthcare Private Limited
Dental · 59d
Cleared Nov 22, 2024
Additively Manufactured Denture Resin
K242884 · EBI
Aidite (Qinhuangdao) Technology Co.,...
Dental · 60d
Cleared Nov 22, 2024
Manual Wheelchair (MASY23)
K242722 · IOR
Sichuan Ast Medical Equipment Co., Ltd.
Physical Medicine · 73d
Cleared Nov 22, 2024
Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
K242543 · MBH
Zimmer, Inc.
Orthopedic · 88d
Cleared Nov 22, 2024
Cala kIQ
K242259 · QBC
Cala Health, Inc.
Neurology · 114d
Cleared Nov 22, 2024
BriefCase-Quantification
K242203 · QIH
Aidoc Medical , Ltd.
Radiology · 119d
Cleared Nov 22, 2024
Dreem 3S
K242094 · OLZ
Beacon Biosignals, Inc.
Neurology · 128d
Cleared Nov 22, 2024
FemVue MINI Saline-Air Device
K242002 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 136d
Cleared Nov 22, 2024
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
K241953 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 142d
Cleared Nov 22, 2024
Powered Wheelchair (NXN20-209)
K241529 · ITI
Zhejiang Nysin Medical Co., Ltd.
Physical Medicine · 176d
Cleared Nov 22, 2024
Entarik NI Feeding Tube System
K241169 · KNT
Gravitas Medical, Inc.
Gastroenterology & Urology · 210d
Cleared Nov 22, 2024
Neuvotion NeuStim NN-01
K240632 · GZI
Neuvotion, Inc.
Neurology · 261d
Cleared Nov 22, 2024
OsteoCoil™ Nitinol Compression System (Multiple Component PNs)
K233567 · HWC
Flower Orthopedics Corporation Dba...
Orthopedic · 382d
Cleared Nov 22, 2024
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
K221326 · LCP
Nova Biomedical Corporation
Chemistry · 931d
Cleared Nov 21, 2024
Xpert vanA
K243405 · NIJ
Cepheid
Microbiology · 20d
Cleared Nov 21, 2024
GMReis Ankle Plating System
K242998 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 56d
Cleared Nov 21, 2024
Gating Reflector Block
K242874 · JAK
Varian Medical Systems, Inc.
Radiology · 59d
Cleared Nov 21, 2024
ATTUNE™ Revision Hinge Knee
K242871 · KRO
Depuy Ireland UC
Orthopedic · 59d
Cleared Nov 21, 2024
PliaFX Flo
K242799 · MBP
Lifenet Health
Orthopedic · 65d