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
26209–26232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2018
Trans-anal Introducer
K171208 · FED
Visionsense, Ltd.
Gastroenterology & Urology · 286d
Cleared Feb 05, 2018
BETTERCARE PLATFORM - ADVANCED WEB CLIENT
K171361 · MWI
Better Care, S.L.
Cardiovascular · 272d
Cleared Feb 05, 2018
Flip Lube
K171516 · NUC
Imquest Biosciences, Inc.
Obstetrics & Gynecology · 257d
Cleared Feb 05, 2018
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First...
K171695 · NFT
W.H.P.M., Inc.
Toxicology · 243d
Cleared Feb 05, 2018
Aquilex Fluid Control System AQL-100S
K172040 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 215d
Cleared Feb 05, 2018
RS85 Diagnostic Ultrasound System
K173204 · IYN
Samsung Medison Co., Ltd.
Radiology · 126d
Cleared Feb 05, 2018
ProxiDiagnost N90
K173433 · OWB
Philips Medical Systems Dmc GmbH
Radiology · 95d
Cleared Feb 05, 2018
MFI-Cardiac
K173512 · LLZ
Multifunctional Imaging, LLC
Radiology · 84d
Cleared Feb 05, 2018
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
K173672 · QEW
Inari Medical
Cardiovascular · 67d
Cleared Feb 05, 2018
DRX-Revolution Nano Mobile X-ray System
K173924 · IZL
Carestream Health, Inc.
Radiology · 41d
Cleared Feb 02, 2018
IMD's Lumbar Puncture Needle
K170112 · BSP
International Medical Development,...
Anesthesiology · 386d
Cleared Feb 02, 2018
KARL STORZ Slim Nasopharyngolaryngoscope
K171402 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 266d
Cleared Feb 02, 2018
OralTox Oral Fluid Drug Test
K171403 · DJC
Premier Biotech, Inc.
Toxicology · 266d
Cleared Feb 02, 2018
Glooko Mobile Insulin Dosing System
K171450 · NDC
Glooko, Inc.
General Hospital · 261d
Cleared Feb 02, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K172005 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 214d
Cleared Feb 02, 2018
The Plateau-LO Spacer System
K172105 · MAX
Life Spine, Inc.
Orthopedic · 205d
Cleared Feb 02, 2018
Bicera Resorbable Bone Substitute
K172237 · MQV
Wiltrom Corporation Limited
Orthopedic · 192d
Cleared Feb 02, 2018
ACRO HCG Pregnancy Rapid Test
K172512 · LCX
Acro Biotech, Inc.
Chemistry · 165d
Cleared Feb 02, 2018
Materialise TKA Guide System
K173445 · JWH
Materialise NV
Orthopedic · 88d
Cleared Feb 02, 2018
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
K173800 · MQP
Camber Spine Technologies
Orthopedic · 50d
Cleared Feb 02, 2018
Triathlon Total Knee System
K173849 · MBH
Stryker Orthopaedics
Orthopedic · 45d
Cleared Feb 02, 2018
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic...
K173981 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 35d
Cleared Feb 02, 2018
SMAXEL CO2 Surgical Laser System
K180036 · ONG
Ids, Ltd.
General & Plastic Surgery · 28d
Cleared Feb 02, 2018
SpeediCath Flex Coude Pro
K180070 · GBM
Coloplast
Gastroenterology & Urology · 24d