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
7513–7536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2024
Advanta VXT Vascular Graft, Flixene Vascular Graft
K231972 · DSY
Atrium Medical Corporation
Cardiovascular · 269d
Cleared Mar 27, 2024
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )
K240389 · NEW
Hyundae Meditech Co., Ltd.
General & Plastic Surgery · 48d
Cleared Mar 27, 2024
QStat Cartridge
K240045 · QFR
Hemosonics, LLC
Hematology · 82d
Cleared Mar 27, 2024
Lucent® XP
K234150 · MAX
Spinal Elements
Orthopedic · 89d
Cleared Mar 27, 2024
i-STAT TBI Cartridge with the i-STAT Alinity System
K234143 · QAT
Abbott Point of Care
Immunology · 89d
Cleared Mar 27, 2024
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested...
K234097 · LZA
Ever Growth (Vietnam) Corporation...
General Hospital · 92d
Cleared Mar 27, 2024
CarboClear® Posterior Cervical Screw System
K233989 · NKG
CarboFix Orthopedics , Ltd.
Orthopedic · 100d
Cleared Mar 27, 2024
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
K233951 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
Cleared Mar 27, 2024
MAMMOMAT B.brilliant
K233539 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 145d
Cleared Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201 · QJP
Penumbra, Inc.
Neurology · 181d
Cleared Mar 27, 2024
CARPL (CARPL)
K232891 · LLZ
Carpl Ai, Inc.
Radiology · 191d
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