FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
14473–14496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2022
Breast BI Coil Set 0.55T
K220144 · MOS
Noras Mri Products GmbH
Radiology · 79d
Cleared Apr 08, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K220192 · LNH
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 08, 2022
ImaCor Zura Handheld ZHH-010
K220490 · IYN
Imacor, Inc.
Radiology · 45d
Cleared Apr 08, 2022
Prestige Coil System
K220699 · KRD
Bait USA, LLC
Cardiovascular · 29d
Cleared Apr 08, 2022
CD Horizon™ Spinal System and PASS LP™ Spinal System
K220724 · NKB
Medicrea International
Orthopedic · 25d
Cleared Apr 08, 2022
Drive Rail System
K220809 · KTT
OrthoPediatrics Corp.
Orthopedic · 18d
Cleared Apr 07, 2022
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
K210860 · FXX
Gri-Alleset, Inc.
General Hospital · 380d
Cleared Apr 07, 2022
Green OR Reprocessed Aquamantys Bipolar Sealer
K211203 · NUJ
Green Or, LLC
General & Plastic Surgery · 350d
Cleared Apr 07, 2022
Corin MetaFix™ Hip Stem
K212069 · LZO
Corin U.S.A. Limited
Orthopedic · 279d
Cleared Apr 07, 2022
Dong Hai Xiang Surgical Mask
K212203 · FXX
Taizhou Donghaixiang Protective...
General Hospital · 267d
Cleared Apr 07, 2022
Electrocardiograph
K212278 · DPS
Edan Instruments, Inc.
Cardiovascular · 261d
Cleared Apr 07, 2022
Invisalign System
K220287 · NXC
Align Technology, Inc.
Dental · 65d
Cleared Apr 06, 2022
Plasmage System
K202106 · GEI
Brera Medical, Inc.
General & Plastic Surgery · 616d
Cleared Apr 06, 2022
MTM301 Blood Glucose and Ketone Monitoring System
K202534 · NBW
Apex BioTechnology Corp.
Chemistry · 582d
Cleared Apr 06, 2022
ClariPulmo
K203783 · LLZ
Claripi, Inc.
Radiology · 464d
Cleared CT Apr 06, 2022
Onera Sleep Test System (Onera STS)
K210593 · MNR
Onera B.V.
Neurology · 401d
Cleared Apr 06, 2022
Extended Reservoir
K210714 · LZG
Medtronic Minimed, Inc.
Chemistry · 392d
Cleared Apr 06, 2022
NB 1 SA Implant System
K213506 · DZE
Arum Dentistry Co., Ltd.
Dental · 156d
Cleared Apr 06, 2022
Balloon Dilatation Catheter
K213578 · FDF
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 147d
Cleared Apr 06, 2022
3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid...
K213809 · FRC
3M Company
General Hospital · 121d
Cleared Apr 06, 2022
Disposable Medical Mask
K214085 · FXX
Hubei Wanli Protective Products Co.,...
General Hospital · 100d
Cleared Apr 06, 2022
Prodigy Thrombectomy System
K214114 · QEW
Truvic Medical, Inc.
Cardiovascular · 97d
Cleared Apr 06, 2022
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K220625 · OBP
Remed Co., Ltd.
Neurology · 34d
Cleared Apr 06, 2022
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
K220654 · NTE
Cordis Corporation
Cardiovascular · 30d