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
9505–9528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2023
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
K220977 · JGS
Beckman Coulter Laboratory Systems...
Chemistry · 472d
Cleared Jul 20, 2023
Panther 5
K213098 · CBK
Origin Medical Devices
Anesthesiology · 664d
Cleared Jul 19, 2023
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
K231839 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 27d
Cleared Jul 19, 2023
Grreen X 12 (Model: PHT-75CHS)
K231796 · OAS
VATECH Co., Ltd.
Radiology · 29d
Cleared Jul 19, 2023
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
K231472 · INI
Suzhou Sweetrich Vehicle Industry...
Physical Medicine · 58d
Cleared Jul 19, 2023
TANDEM Hip System
K231448 · LZY
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Jul 19, 2023
LF900
K231437 · IRP
Daesung Maref Co., Ltd.
Physical Medicine · 63d
Cleared Jul 19, 2023
RenaPure Endotoxin Retentive Filter
K231410 · FIP
Evoqua Water Technologies, LLC
Gastroenterology & Urology · 65d
Cleared Jul 19, 2023
TAMINA 3.5mm Proximal Humerus System
K231292 · HRS
Bonebridge AG
Orthopedic · 76d
Cleared Jul 19, 2023
syngo.CT Lung CAD (Version VD30)
K231157 · OEB
Siemens Healthcare GmbH
Radiology · 86d
Cleared Jul 19, 2023
BACK 3
K230037 · PBX
Swims America Corp
General & Plastic Surgery · 194d
Cleared Jul 19, 2023
Nu-beca Transcutaneous Electrical Nerve Stimulation
K223151 · NUH
Nu-Beca & Maxcellent Co.
Neurology · 287d
Cleared Jul 19, 2023
AXINON® LDL-p Test System
K210801 · MRR
Numares AG
Chemistry · 854d
Cleared Jul 18, 2023
Forma Medical Headless Compression Screw
K230945 · HWC
Forma Medical, Inc.
Orthopedic · 105d
Cleared Jul 18, 2023
Robotic Graft Delivery Instruments
K230716 · OLO
Medtronic Sofamor Danek, Inc.
Orthopedic · 125d
Cleared Jul 18, 2023
Bone Chamber Implant
K223339 · DZE
Megagen Implant Co., Ltd.
Dental · 259d
Cleared Jul 18, 2023
Hypodermic Syringes & Needle
K222925 · FMF
Lifelong Meditech Private Limited
General Hospital · 295d
Cleared Jul 18, 2023
TRUST
K221107 · PNP
Rgorithm Korea
Dental · 459d
Cleared Jul 18, 2023
FMT Reusable Temperature Probes
K213100 · FLL
Metko Medikal VE Ttbbi Cihazlar D1s...
General Hospital · 662d
Cleared Jul 17, 2023
Avitus® DragonWing Large Volume Autograft Delivery System
K231456 · FMF
Avitus Orthopaedics, Inc.
Orthopedic · 59d
Cleared Jul 17, 2023
ARIX Ankle System
K231441 · HRS
Jeil Medical Corporation
Orthopedic · 60d
Cleared Jul 17, 2023
iTotal Identity Knee Replacement System
K230846 · JWH
Conformis, Inc.
Orthopedic · 111d
Cleared Jul 17, 2023
Revital-Ox PAA High Level Disinfectant Chemical Indicator
K230558 · JOJ
STERIS Corporation
General Hospital · 139d
Cleared Jul 17, 2023
OPTIX H2 Patient Specific Instrument System
K230462 · HSN
Vilex, LLC
Orthopedic · 146d