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
7249–7272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2024
Modius Stress
K232253 · QJQ
Neurovalens Limited
Neurology · 243d
Cleared Mar 27, 2024
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
K231425 · NUH
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 315d
Cleared Mar 27, 2024
LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial...
K223360 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 510d
Cleared Mar 27, 2024
ARX Liquid Amies Collection & Transport System
K222613 · LIO
Arx Sciences, Inc.
Microbiology · 575d
Cleared Mar 26, 2024
Grappler Suture Anchor R3FLEX IOL System
K240594 · MBI
Paragon 28, Inc.
Orthopedic · 22d
Cleared Mar 26, 2024
SyMRI
K233733 · LNH
Syntheticmr AB (Publ.)
Radiology · 126d
Cleared Mar 26, 2024
SOMATOM go.Up
K233650 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Mar 26, 2024
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control...
K233611 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 134d
Cleared Mar 26, 2024
PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound...
K233151 · FRO
Medline Industries, LP
General & Plastic Surgery · 181d
Cleared Mar 26, 2024
Removal System Large Bore 60 cc Syringe
K233069 · PUR
Inari Medical, Inc.
General Hospital · 182d
Cleared Mar 26, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
K232954 · QOF
Biofire Diagnostics, LLC
Microbiology · 187d
Cleared Mar 26, 2024
Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
K231984 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 265d
Cleared Mar 26, 2024
RODIN 3D Resin SPLINT, Hard/Flex
K231793 · MQC
Belport Company, Inc., Gingi-Pak
Dental · 280d
Cleared Mar 26, 2024
J & P Click Attachments
K231132 · NHA
J & P Dental Technologies
Dental · 340d
Cleared Mar 25, 2024
Cube Navigator
K240620 · LLZ
Medical Templates AG
Radiology · 20d
Cleared Mar 25, 2024
Micropuncture Introducer Sets
K240589 · DYB
Cook, Medical
Cardiovascular · 24d
Cleared Mar 25, 2024
Electric wheelchair (YHW001-C
K240329 · ITI
Yongkang Youha Electric Appliance...
Physical Medicine · 49d
Cleared Mar 25, 2024
Transcutaneous Electrical Nerve Stimulator (9029SCM)
K240292 · NUH
Hong Kong Etech Groups Limited
Neurology · 53d
Cleared Mar 25, 2024
LUNE™ PureHygiene
K234085 · GEX
Enamel Pure
Dental · 94d
Cleared Mar 25, 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K234080 · GWF
Soterix Medical, Inc.
Neurology · 94d
Cleared Mar 25, 2024
VariAx 2 Distal Radius System
K233919 · HRS
Stryker GmbH
Orthopedic · 103d
Cleared Mar 25, 2024
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard)
K233275 · FGB
Gyrus Acmi, Inc.
Gastroenterology & Urology · 178d
Cleared Mar 25, 2024
LW Implant System – Abutment
K233167 · NHA
Ossvis Co., Ltd.
Dental · 180d
Cleared Mar 25, 2024
STERI-OSS Implant System
K232268 · DZE
Zeros Co., Ltd.
Dental · 238d