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
8713–8736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2023
Freedom60 Infusion Pump
K231918 · FRN
Koru Medical Systems
General Hospital · 127d
Cleared Nov 03, 2023
Endophys Blood Pressure Monitor model BPM-30
K231586 · DSK
Endophys Technologies, LLC
Cardiovascular · 156d
Cleared Nov 03, 2023
ManaFlexx 2 (model: MF002-RX, MF002-OTC)
K231569 · NUH
Manamed, Inc.
Neurology · 156d
Cleared Nov 03, 2023
Combo Electrotherapy Device
K231440 · IPF
Shenzhen Roundwhale Technology Co. ,...
Physical Medicine · 169d
Cleared Nov 03, 2023
GripTract-GI Endoscopic Tissue Manipulator
K231254 · FDF
Actuated Medical, Inc.
Gastroenterology & Urology · 186d
Cleared Nov 03, 2023
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature...
K231182 · NZE
Zoll Circulation, Inc.
Cardiovascular · 191d
Cleared Nov 03, 2023
Evenflo Premium Double Electric Breast Pump (Model 4018)
K230481 · HGX
Evenflo Feeding, Inc.
Obstetrics & Gynecology · 254d
Cleared Nov 03, 2023
Medical Video Endoscope System
K230475 · FGB
Huger Medical Instrument Co., Ltd.
Gastroenterology & Urology · 254d
Cleared Nov 03, 2023
ProSeal™ Closed System Administration Set
K230343 · FPA
Epic Medical Pte. , Ltd.
General Hospital · 268d
Cleared Nov 03, 2023
SCIZER (SC1-M410)
K230100 · OHV
Classys, Inc.
General & Plastic Surgery · 294d
Cleared Nov 03, 2023
TRAX® CR Total Knee System
K230078 · JWH
Amplitude
Orthopedic · 297d
Cleared Nov 02, 2023
BASE290 LED Curing Light
K233518 · EBZ
Handpiece Headquarters
Dental · 1d
Cleared Nov 02, 2023
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
K233407 · PZX
AtriCure, Inc.
Cardiovascular · 28d
Cleared Nov 02, 2023
BioSieveTM Multi-Drug Urine Test Panel
K233062 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 37d
Cleared Nov 02, 2023
EpiZact
K233056 · FMF
Guidestar Medical Devices
Anesthesiology · 38d
Cleared Nov 02, 2023
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
K232725 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 57d
Cleared Nov 02, 2023
Nd:Yag Laser Therapy Systems
K232532 · GEX
Beijing Unt Technology Co., Ltd.
General & Plastic Surgery · 73d
Cleared Nov 02, 2023
ATEC Posterior Navigated Disc Prep Instruments
K232345 · OLO
Alphatec Spine, Inc.
Orthopedic · 90d
Cleared Nov 02, 2023
STELLAR Knee
K232176 · SBF
Polarisar, Inc.
Orthopedic · 104d
Cleared Nov 02, 2023
Fibercure
K232076 · QNF
Lumendo AG
Dental · 112d
Cleared Nov 02, 2023
VersaWrap Nerve Protector
K232029 · JXI
Alafair Biosciences, Inc.
Neurology · 118d
Cleared Nov 02, 2023
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F...
K230800 · KPR
GEMSS HEALTHCARE CO., LTD.
Radiology · 224d
Cleared Nov 02, 2023
ENFit to ENFit Extension Sets
K230326 · PIF
Vesco Medical
Gastroenterology & Urology · 269d
Cleared Nov 01, 2023
TERA HARZ II
K233502 · EBF
Graphy, Inc.
Dental · 1d