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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14089–14112 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2022
Cardiovascular Suite 4.2.1
K202094 · DQK
Quipu S.R.L
Cardiovascular · 532d
Cleared Jan 11, 2022
Ora-Aid
K211851 · OLR
Tbm Corporation
General & Plastic Surgery · 210d
Cleared Jan 11, 2022
Disposable Surgical Gown
K212591 · FYA
Suzhou Janee Medical Technology Co.,...
General Hospital · 148d
Cleared Jan 11, 2022
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
K212735 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 134d
Cleared Jan 11, 2022
ES1 System
K213102 · IYN
E-Scopics
Radiology · 109d
Cleared Jan 11, 2022
Medical Examination Gloves
K213168 · LZA
Shandong Huiwosheng Health Technology...
General Hospital · 105d
Cleared Jan 11, 2022
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
K213199 · HWC
Stryker GmbH
Orthopedic · 104d
Cleared Jan 11, 2022
360CAS
K213380 · OLO
Kico Knee Innovation Company Pty Limited
Orthopedic · 90d
Cleared Jan 11, 2022
High Retention Attachment System
K213391 · NHA
Zest Anchors, LLC
Dental · 88d
Cleared Jan 11, 2022
Esteya
K213942 · JAD
Nucletron B.V.
Radiology · 25d
Cleared Jan 10, 2022
Sheng Jing Tang Surgical Mask
K211260 · FXX
Liaoning Shengjingtang Biotechnology...
General Hospital · 259d
Cleared Jan 10, 2022
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
K211274 · BZD
Sleepnet Corporation
Anesthesiology · 258d
Cleared Jan 10, 2022
Gingi-Aid Gel
K211419 · MVL
Belport Company, Inc., Gingi-Pak
Dental · 248d
Cleared Jan 10, 2022
Romero Cervical Cage
K212358 · OVE
Spineup, Inc.
Orthopedic · 165d
Cleared Jan 10, 2022
DUMI ManipulatOR
K212505 · LKF
The O R Company Pty, Ltd.
Obstetrics & Gynecology · 154d
Cleared Jan 10, 2022
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
K212541 · EBI
Deltamed GmbH
Dental · 151d
Cleared Jan 10, 2022
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat...
K212688 · DTR
Qura S.R.L
Cardiovascular · 138d
Cleared Jan 10, 2022
Powered Wheelchair
K212854 · ITI
Zhejiang Qianxi Vehicle Co., Ltd.
Physical Medicine · 124d
Cleared Jan 10, 2022
G-Tech Wireless Patch System (WPS)
K212954 · MYE
G-Tech Medical
Gastroenterology & Urology · 116d
Cleared Jan 10, 2022
MagnetOs granules
K213111 · MQV
Kuros Biosciences B.V
Orthopedic · 108d
Cleared Jan 09, 2022
Powder Free Nitrile Examination Gloves, Blue Chemotest
K211666 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 222d
Cleared Jan 09, 2022
Powder free nitrile examination glove- black, non sterile
K212801 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 129d
Cleared Jan 07, 2022
EK Implants and Abutments System
K203360 · DZE
Hiossen, Inc.
Dental · 417d
Cleared Jan 07, 2022
CORE1 Implant System
K210039 · DZE
Cybermed, Inc.
Dental · 366d