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
13441–13464 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2022
Wireless Digital Flat Panel Detector
K220668 · MQB
Iray Technology Taicang , Ltd.
Radiology · 25d
Cleared Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · NBC
Roche Diagnostics
Chemistry · 399d
Cleared Mar 31, 2022
Alexis Contained Extraction System
K211043 · GCJ
Applied Medical Resources Corporation
Obstetrics & Gynecology · 357d
Cleared Mar 31, 2022
ERIC Retrieval Device
K211120 · NRY
MicroVention, Inc.
Neurology · 350d
Cleared Mar 31, 2022
Golnit Nylon Monofilament Suture
K212888 · GAR
Antarma, LLC Dba Golnit Sutures
General & Plastic Surgery · 202d
Cleared Mar 31, 2022
PhasTIPP
K212894 · DWQ
LeMaitre Vascular, Inc.
Cardiovascular · 202d
Cleared Mar 31, 2022
Medical Face Mask
K213736 · FXX
Hangzhou Runheng Medical Co., Ltd.
General Hospital · 122d
Cleared Mar 31, 2022
Air Compression Therapy Device, model: ST-502
K213745 · IRP
Shenzhen Future Electronic Co., Ltd.
Physical Medicine · 122d
Cleared Mar 31, 2022
Nitrile Examination Gloves
K213843 · LZA
Dong Tai City Huayi Gloves Co., Ltd.
General Hospital · 112d
Cleared Mar 31, 2022
STATIM 6000B Vacuum Autoclave
K214057 · FLE
Scican , Ltd.
General Hospital · 94d
Cleared Mar 31, 2022
ARx® Spinal System
K220025 · NKB
Life Spine, Inc.
Orthopedic · 85d
Cleared Mar 31, 2022
PediGuard Threaded
K220160 · PDQ
Spineguard S.A.
Neurology · 71d
Cleared Mar 31, 2022
Uterine ElevatOR PRO with OccludOR Balloon
K220202 · LKF
The O R Company Pty, Ltd.
Obstetrics & Gynecology · 66d
Cleared Mar 31, 2022
Vinyl Co-Polymer Powder-free Examination Gloves, Black
K220240 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 62d
Cleared Mar 31, 2022
Hercules Syndesmosis Implant System
K220260 · HTN
In2bones USA, LLC
Orthopedic · 59d
Cleared Mar 31, 2022
NEXXT SPINE NAVIGATION System
K220291 · OLO
Nexxt Spine, LLC
Orthopedic · 58d
Cleared Mar 31, 2022
Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy...
K220353 · LZC
Niujian Technology Co., Ltd.
General Hospital · 51d
Cleared Mar 31, 2022
BD Cathena Safety IV Catheter
K220584 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 30d
Cleared Mar 31, 2022
TargetCool
K220674 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 23d
Cleared Mar 31, 2022
APX-24 Portable X-ray System
K220678 · IZL
Aspenstate, Inc.
Radiology · 23d
Cleared Mar 30, 2022
INTAI Surgical Mask (non-sterile)
K210422 · FXX
Intai Technology Corp.
General Hospital · 412d
Cleared Mar 30, 2022
EON
K211681 · PKT
Dominion Aesthetic Technologies, Inc.
General & Plastic Surgery · 302d
Cleared Mar 30, 2022
Shield System
K212159 · OWB
Radiaction , Ltd.
Radiology · 261d
Cleared Mar 30, 2022
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
K212464 · QPC
Dukal Corporation
General Hospital · 236d