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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13489–13512 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2022
Powder Free Nitrile Examination Gloves, Orange
K220229 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 58d
Cleared Mar 25, 2022
Infusion Sets for Single Use
K202437 · FPA
Jiangsu Suyun Medical Materials Co.,...
General Hospital · 577d
Cleared Mar 25, 2022
Pluski Safe 1 Safety IV Catheter
K210037 · FOZ
Mediplus (India) Limited
General Hospital · 443d
Cleared Mar 25, 2022
Biobeat Platform, BB-613WP Patch
K212153 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 259d
Cleared Mar 25, 2022
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210...
K212231 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 252d
Cleared Mar 25, 2022
Luna G3 BPAP System
K212263 · BZD
3B Medical, Inc.
Anesthesiology · 248d
Cleared Mar 25, 2022
Nebulizer
K212395 · CAF
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 235d
Cleared Mar 25, 2022
Toro-L Interbody Fusion System
K213355 · MAX
Integrity Implants, Inc.
Orthopedic · 164d
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