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: 2026–2026 ×
1,922 results
841–864 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 04, 2026
Q-Switched Nd: YAG Laser Systems
K260256 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 96d
Cleared May 04, 2026
ArteraAI Breast
K254115 · SHW
Artera, Inc.
Pathology · 136d
Cleared May 04, 2026
Wound Geni NPWT System
K254019 · OMP
Bechtel Medical, Inc.
General & Plastic Surgery · 140d
Cleared May 04, 2026
Leaseir MHR Xcell (console) (MHR-100b)
K253251 · GEX
Leaseir Technologies, Slu
General & Plastic Surgery · 217d
Cleared May 04, 2026
MammoSightAI
K252954 · QFM
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 230d
Cleared May 04, 2026
Male Latex Condom HA
K252622 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 258d
Cleared May 04, 2026
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P,...
K252543 · FPA
Amsino International, Inc.
General Hospital · 265d
Cleared May 01, 2026
BIOMONITOR IV (471155)
K261074 · MXD
Biotronik, Inc.
Cardiovascular · 30d
Cleared May 01, 2026
Verifine Safety Lancets
K261045 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 31d
Cleared May 01, 2026
EndoTool IV Cloud 1.0
K260910 · NDC
Glooko, Inc.
Chemistry · 43d
Cleared May 01, 2026
Any-Com Seal
K260819 · EBC
Mediclus Co., Ltd.
Dental · 49d
Cleared May 01, 2026
Ancora-SB
K260314 · FDA
Aspero Medical, Inc.
Gastroenterology & Urology · 91d
Cleared May 01, 2026
Phototherapy System (DUV-COMBO)
K254234 · FTC
Choyang Medics Co., Ltd.
General & Plastic Surgery · 123d
Cleared May 01, 2026
FX V135 EASYTECH® Shoulder System
K254154 · PKC
FX Shoulder Solutions, Inc.
Orthopedic · 130d
Cleared May 01, 2026
BioCode® Respiratory Pathogen Panel (RPP)
K254139 · OCC
Applied BioCode, Inc.
Microbiology · 130d
Cleared May 01, 2026
OSSIOfiber® Threaded Trimmable Fixation Nail
K254077 · HWC
OSSIO , Ltd.
Orthopedic · 134d
Cleared May 01, 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · NKB
Spineart SA
Orthopedic · 141d
Cleared May 01, 2026
Nasal Alar SpO2 Sensor (989803205381)
K253887 · DQA
Philips Medizin Systeme
Anesthesiology · 148d
Cleared May 01, 2026
Zeta Navigation System
K253663 · HAW
Zeta Surgical, Inc.
Neurology · 162d
Cleared May 01, 2026
Oxiplex
K253326 · QVL
Fziomed, Inc.
Orthopedic · 213d
Cleared May 01, 2026
Capnostream™35 Portable Respiratory Monitor (PM35MN)
K253030 · CCK
Covidien, LLC
Anesthesiology · 224d
Cleared May 01, 2026
ArthroTAK Tendon Anchor Kit
K252635 · MBI
ArthroTAK, LLC
Orthopedic · 254d
Cleared May 01, 2026
ABL90 FLEX PLUS System
K252488 · CGA
Radiometer Medicals Aps
Chemistry · 266d
Cleared May 01, 2026
ABL90 FLEX PLUS System
K252475 · JGS
Radiometer Medicals Aps
Chemistry · 267d