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
9001–9024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2023
Standard Staple-Line Reinforcement (SSLR23)
K231603 · OXC
Standard Bariatrics, Inc.
General & Plastic Surgery · 127d
Cleared Oct 06, 2023
Nutricair Enteral Syringe with ENFit
K231300 · PNR
Cair Lgl
Gastroenterology & Urology · 155d
Cleared Oct 06, 2023
EARP Nerve Cuff Electrode
K230853 · ETN
Nvision Biomedical Technologies, Inc.
Neurology · 192d
Cleared Oct 06, 2023
Patient Examination Gloves
K230777 · LZA
3A Glove Sdn. Bhd.
General Hospital · 199d
Cleared Oct 06, 2023
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
K230265 · DSI
Infobionic, Inc.
Cardiovascular · 248d
Cleared Oct 06, 2023
Denti.AI Detect
K230144 · MYN
Denti.Ai Technology, Inc.
Radiology · 261d
Cleared Oct 06, 2023
THE Cover
K230091 · NPL
Purgo Biologics, Inc.
Dental · 267d
Cleared Oct 06, 2023
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
K223926 · FAJ
Medimaging Integrated Solution, Inc...
Gastroenterology & Urology · 280d
Cleared Oct 06, 2023
Vivio® LVEDP System
K223905 · QUO
Avicena, LLC
Cardiovascular · 282d
Cleared Oct 06, 2023
accufit
K223802 · IPF
Mettler Electronics Corporation
Physical Medicine · 291d
Cleared Oct 06, 2023
Disposable Sterile Syringe
K221777 · FMF
Weihai Shengjie Medical Technology...
General Hospital · 472d
Cleared Oct 05, 2023
Tandem Mobi insulin pump with interoperable technology
K233044 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 10d
Cleared Oct 05, 2023
Clarius Ultrasound Scanner
K232704 · IYN
Clarius Mobile Health Corp.
Radiology · 30d
Cleared Oct 05, 2023
Heating Tens, FT-615
K232675 · NUH
Hivox Biotek, Inc.
Neurology · 34d
Cleared Oct 05, 2023
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
K232395 · JWY
Biom?rieux
Microbiology · 57d
Cleared Oct 05, 2023
cmAngio® V1.0
K232367 · QIH
Curemetrix, Inc.
Radiology · 58d
Cleared Oct 05, 2023
LifeStyles NRL Textured Condom
K232279 · HIS
Suretex Limited
Obstetrics & Gynecology · 66d
Cleared Oct 05, 2023
All-Suture Anchor
K231078 · MBI
Riverpoint Medical, LLC
Orthopedic · 171d
Cleared Oct 05, 2023
DeepTek CXR Analyzer v1.0
K231001 · MYN
Deeptek Medical Imaging Pvt, Ltd.
Radiology · 181d
Cleared Oct 05, 2023
MFG-05
K230780 · KPI
Zimmer Medizinsysteme GmbH
Gastroenterology & Urology · 197d
Cleared Oct 05, 2023
OsteoCentric Dental Implant System
K230242 · DZE
OsteoCentric Technologies
Dental · 248d
Cleared Oct 05, 2023
MESORAM® Hypodermic Needle (710301)
K230070 · FMI
Promamedical, Inc.
General Hospital · 268d
Cleared Oct 05, 2023
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
K223740 · CAW
Jiangsu Konsung Bio-Medical Science...
Anesthesiology · 295d
Cleared Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex
K221550 · DJG
Randox Laboratories Limited
Toxicology · 492d