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
2977–3000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 28, 2025
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 28, 2025
NUVENTUS NV.C™ Prosthetic Components
K251220 · NHA
Infinitum Eta, Ltd.
Dental · 98d
Cleared Jul 28, 2025
3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
K251187 · NUH
Changsha Anxiang Medical Technology...
Physical Medicine · 102d
Cleared Jul 28, 2025
NAEOTOM Alpha.Peak/NAEOTOM Alpha
K251061 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 115d
Cleared Jul 28, 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
K250652 · QYE
Anumana, Inc.
Cardiovascular · 146d
Cleared Jul 28, 2025
Alinity m EBV (09N43-095)
K243489 · QLX
Abbott Molecular, Inc.
Microbiology · 258d
Cleared Jul 28, 2025
ISO Abutment
K241183 · NHA
Seum Medi Co., Ltd.
Dental · 455d
Cleared Jul 25, 2025
InbellaMAX System
K252215 · GEI
Inbella Medical , Ltd.
General & Plastic Surgery · 10d
Cleared Jul 25, 2025
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
K252033 · FMF
CMT Health PTE., Ltd.
General Hospital · 25d
Cleared Jul 25, 2025
Triathlon® Hinge Knee System
K251665 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Jul 25, 2025
A.L.P.S. Proximal Humerus Plating System
K251620 · HRS
Zimmer Biomet
Orthopedic · 59d
Cleared Jul 25, 2025
Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02,...
K251339 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 86d
Cleared Jul 25, 2025
Venue
K251322 · IYN
GE Medical Systems Ultrasound and...
Radiology · 87d
Cleared Jul 25, 2025
Stryker and Serf hip devices
K250989 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 116d
Cleared Jul 25, 2025
Marie
K250970 · JAK
Leo Cancer Care
Radiology · 116d
Cleared Jul 25, 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K250859 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 126d
Cleared Jul 25, 2025
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K250552 · DQX
Abbott Medical
Cardiovascular · 150d
Cleared Jul 25, 2025
Fusion Craniofacial Implant
K250334 · GWO
Kelyniam Global, Inc.
Neurology · 170d
Cleared Jul 25, 2025
Compression Therapy Device (LGT-2210DS)
K250244 · IRP
Guangzhou Longest Medical Technology...
Physical Medicine · 179d
Cleared Jul 25, 2025
Vathin® Video Bronchoscope System
K250232 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 179d
Cleared Jul 25, 2025
BD Nexiva™ Closed IV Catheter System
K243403 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 267d
Cleared Jul 25, 2025
Heated Breathing Tube
K243244 · BZE
Guangdong Eda Technology Co., Ltd.
Anesthesiology · 287d
Cleared Jul 24, 2025
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
K252056 · OCL
AtriCure, Inc.
Cardiovascular · 23d