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
14593–14616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2022
DTX Studio Clinic 3.0
K213562 · LLZ
Nobel Biocare AB
Radiology · 136d
Cleared Mar 25, 2022
BALTEUM - ONE™ Lumbar Plate System
K213820 · KWQ
Huvexel Co. , Ltd.
Orthopedic · 107d
Cleared Mar 25, 2022
Medical nitrile examination gloves (Model: JL001)
K213848 · LZA
Guangdong Jiali Pharmaceutical Co.,Ltd
General Hospital · 105d
Cleared Mar 25, 2022
Medical Surgical Mask (Model: JM92, JM92B)
K220187 · FXX
Guangdong Jia Mei Biological...
General Hospital · 60d
Cleared Mar 25, 2022
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10...
K220242 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared Mar 25, 2022
LE-12CH
K220362 · DPS
Caf Medical Solutions, Inc.
Cardiovascular · 45d
Cleared Mar 25, 2022
Artix Thrombectomy Device
K220600 · QEW
Inari Medical
Cardiovascular · 23d
Cleared Mar 25, 2022
3 Ply Medical Grade Single Use Procedural Disposable Face Mask
K220637 · FXX
Kdi Med Supply
General Hospital · 21d
Cleared Mar 24, 2022
Surgical Face Mask
K202903 · FXX
Rizhao Sanqi Medical & Health...
General Hospital · 541d
Cleared Mar 24, 2022
Alio Medical Remote Monitoring System
K211365 · DRG
Graftworx, Inc. Dba Alio
Cardiovascular · 324d
Cleared Mar 24, 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K212916 · LZA
Rimba Glove Sdn Bhd
General Hospital · 192d
Cleared Mar 24, 2022
AviClear Laser System
K213461 · GEX
Cutera, Inc.
General & Plastic Surgery · 148d
Cleared Mar 24, 2022
Dib UltraNav Transseptal Catheter System
K213492 · DYB
Dib Ultranav Medical, LLC
Cardiovascular · 143d
Cleared Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
K213589 · QJP
Asahi Intecc Co., Ltd.
Neurology · 132d
Cleared Mar 24, 2022
Steth IO Spot
K220196 · DQD
Stratoscientific
Cardiovascular · 59d
Cleared Mar 24, 2022
Mobility Scooter
K220206 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 58d
Cleared Mar 24, 2022
Mobility Scooter, Model W3468
K220207 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 58d
Cleared Mar 24, 2022
Disposable Medical Synthetic Nitrile Examination Gloves
K220354 · LZA
Niujian Technology Co., Ltd.
General Hospital · 44d
Cleared Mar 24, 2022
FlareHawk Interbody Fusion System
K220453 · MAX
Integrity Implants, Inc.
Orthopedic · 35d
Cleared Mar 24, 2022
Erchonia Zerona Z-Bed
K220519 · OLI
Erchonia Corporation
General & Plastic Surgery · 29d
Cleared Mar 24, 2022
Emerge Monorail PTCA Dilatation Catheter
K220629 · LOX
Boston Scientific
Cardiovascular · 20d
Cleared Mar 24, 2022
X-Pac Expandable Lumbar Cage System
K220655 · MAX
Expanding Innovations, Inc.
Orthopedic · 17d
Cleared Mar 23, 2022
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial...
K210718 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 378d
Cleared Mar 23, 2022
PathBuilder Transseptal Needle
K212625 · DRC
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 217d