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
4129–4152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2025
Amulet™ Steerable Delivery Sheath
K250426 · DQY
Abbott Medical
Cardiovascular · 70d
Cleared Apr 25, 2025
Intracavitary/Interstitial System
K250289 · JAQ
Varian Medical Systems
Radiology · 84d
Cleared Apr 25, 2025
Neu Platform
K250153 · GYD
Neuhealth Digital , Ltd.
Neurology · 94d
Cleared Apr 25, 2025
Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611,...
K250046 · IRP
Shenzhen Urion Technology Co., Ltd.
Physical Medicine · 105d
Cleared Apr 25, 2025
PAL 7020 Console
K244026 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 116d
Cleared Apr 25, 2025
DCX Disposable Cassette (DCX)
K243998 · KDN
Institut Geroges Lopez
Gastroenterology & Urology · 120d
Cleared Apr 25, 2025
VERIFY STEAM Integrating Indicator
K243876 · JOJ
STERIS Corporation
General Hospital · 128d
Cleared Apr 25, 2025
butterflyBVM
K243861 · BTM
Compact Medical, Inc.
Anesthesiology · 130d
Cleared Apr 25, 2025
BD Alaris Infusion System with Guardrails Suite MX
K243855 · FRN
Carefusion 303, Inc.
General Hospital · 130d
Cleared Apr 25, 2025
i-Cut
K243821 · HET
A.M.I. Agency For Medical Innovations...
Obstetrics & Gynecology · 134d
Cleared Apr 25, 2025
Self Sealing Sterilization Pouches
K243721 · FRG
Wellmed Dental Medical Supply Co., Ltd.
General Hospital · 143d
Cleared Apr 25, 2025
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
K243570 · JLW
Siemens Healthcare Diagnostics
Chemistry · 158d
Cleared Apr 25, 2025
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
K243406 · QOF
Roche Molecular Systems, Inc.
Microbiology · 175d
Cleared Apr 25, 2025
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
K243400 · QOF
Roche Molecular Systems, Inc.
Microbiology · 176d
Cleared Apr 25, 2025
DHF 0.2 Hemoconcentrator (DHF 02)
K243264 · KDI
Sorin Group Italia S.R.L.
Gastroenterology & Urology · 192d
Cleared Apr 25, 2025
Infrared Thermometer
K243082 · FLL
Guangzhou Daxin Health Technology...
General Hospital · 207d
Cleared Apr 25, 2025
contact forte Alpha
K243041 · LXB
Bhm-Tech Produktionsgesellschaft Mbh
Ear, Nose, Throat · 210d
Cleared Apr 25, 2025
RFMagik Lite
K242469 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 248d
Cleared Apr 25, 2025
Kosmos
K242321 · IYN
EchoNous, Inc.
Radiology · 262d
Cleared Apr 24, 2025
GO-PEN®
K250262 · FMF
Go-Pen Aps
General Hospital · 85d
Cleared Apr 24, 2025
Diode laser system (Night Universe
K250206 · GEX
Ivylaser (Beijing) Technology Co.,Ltd
General & Plastic Surgery · 90d
Cleared Apr 24, 2025
CO2 Laser System (CO2 Laser SST-L23)
K250183 · GEX
Zhuozhou Summer Star Technologies...
General & Plastic Surgery · 92d
Cleared Apr 24, 2025
Arm Blood Pressure Monitor (ARM-30H)
K250116 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 98d
Cleared Apr 24, 2025
Smart Check O2 (MA0236)
K250002 · CCL
Life Spark Medical, LLC
Anesthesiology · 112d