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
7993–8016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2023
Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen...
K232736 · DJG
Chemtron Biotech, Inc.
Toxicology · 104d
Cleared Dec 20, 2023
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy...
K232444 · KGO
Grand Work Plastic Products Co., Ltd.
General Hospital · 128d
Cleared Dec 20, 2023
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
K232286 · PGI
Quidel Corporation
Microbiology · 141d
Cleared Dec 20, 2023
Cogent™ Hemodynamic Monitoring System
K232048 · DXG
Icu Medical
Cardiovascular · 163d
Cleared Dec 20, 2023
ARK Methotrexate II Assay
K232017 · LAO
ARK Diagnostics, Inc.
Toxicology · 166d
Cleared Dec 20, 2023
Tactoset® Injectable Bone Substitute
K231968 · MQV
Anika Therapeutics, Inc.
Orthopedic · 170d
Cleared Dec 20, 2023
Perifit Care+
K231780 · HIR
X6 Innovations
Gastroenterology & Urology · 187d
Cleared Dec 20, 2023
Digital image scanner of dental
K231660 · MUH
Jiangsu Dynamic Medical Technology...
Radiology · 196d
Cleared Dec 20, 2023
SPECTRUM® GV Bone Cement
K231556 · LOD
Osteoremedies, LLC
Orthopedic · 204d
Cleared Dec 20, 2023
INNO SLA Submerged Hybrid Ti-Base System
K231411 · NHA
Cowellmedi Co., Ltd.
Dental · 218d
Cleared Dec 20, 2023
HP PTA Balloon Dilatation Catheter
K231402 · LIT
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 219d
Cleared Dec 20, 2023
Pocket Ultrasound System (C10)
K231354 · IYN
Beijing Konted Medical Technology...
Radiology · 224d
Cleared Dec 20, 2023
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
K231227 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 236d
Cleared Dec 20, 2023
syngo Application Software
K230955 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 260d
Cleared Dec 20, 2023
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
K230855 · JKA
Becton, Dickinson and Company
Chemistry · 267d
Cleared Dec 20, 2023
United Orthopedic Knee Patient Specific Instrumentation
K230850 · OOG
Enhatch, Inc.
Orthopedic · 267d
Cleared Dec 20, 2023
MagnetOs Putty
K230736 · MQV
Kuros Biosciences B.V
Orthopedic · 278d
Cleared Dec 20, 2023
Inessa System
K230545 · QFG
Triple Jump Israel , Ltd.
Chemistry · 295d
Cleared Dec 20, 2023
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens...
K223585 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 384d
Cleared Dec 19, 2023
GORE® ACUSEAL Vascular Graft
K233551 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 46d
Cleared Dec 19, 2023
DEKA LILY
K233470 · NGX
El.En S.P.A.
Physical Medicine · 55d
Cleared Dec 19, 2023
Bactiseal EVD Catheter Sets
K233448 · JXG
Integra Lifesciences Production...
Neurology · 60d
Cleared Dec 19, 2023
ZENEX Implant System_Short
K233163 · DZE
Izenimplant Co., Ltd.
Dental · 83d
Cleared Dec 19, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
K233132 · FLE
Primus Sterilizer Company, LLC
General Hospital · 83d