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
11665–11688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2022
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
K221355 · LTK
Ortho-Clinical Diagnostics
Immunology · 216d
Cleared Dec 12, 2022
SIRIUS Endoscope System
K221642 · HET
Precision Robotics (Hong Kong) Limited
General & Plastic Surgery · 189d
Cleared Dec 12, 2022
Hive™ Standalone Cervical System
K223190 · OVE
NanoHive Medical, LLC
Orthopedic · 60d
Cleared Dec 12, 2022
Matrix HA Fusion Porous Cervical IBF System
K223510 · ODP
Innovasis, Inc.
Orthopedic · 20d
Cleared Dec 11, 2022
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
K222733 · LZA
Inner Mongolia Boming Medical...
General Hospital · 93d
Cleared Dec 09, 2022
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054 · FMF
Medline Industries, Inc.
General Hospital · 443d
Cleared Dec 09, 2022
RobPath® Total Hip Application
K220774 · OLO
Hangzhou Lancet Robotics Co., Ltd.
Orthopedic · 268d
Cleared Dec 09, 2022
3D-SHAPER
K220822 · KGI
3D-Shaper Medical S.L
Radiology · 263d
Cleared Dec 09, 2022
PMT Facet Fixation System (PMT FFS)
K220951 · MRW
Providence Medical Technology, Inc.
Orthopedic · 252d
Cleared Dec 09, 2022
Vesseal
K221280 · GAW
Lydus Medical , Ltd.
General & Plastic Surgery · 220d
Cleared Dec 09, 2022
Wearable breast pump
K221598 · HGX
Mayborn (Uk) Limited
Obstetrics & Gynecology · 190d
Cleared Dec 09, 2022
Inogen Rove 4 Portable Oxygen Concentrator
K222086 · CAW
Inogen
Anesthesiology · 147d
Cleared Dec 09, 2022
Swang-Ganz IQ pulmonary artery catheter
K222117 · DYG
Edwards Lifesiences, LLC
Cardiovascular · 144d
Cleared Dec 09, 2022
FloPatch FP120
K222242 · DPW
Flosonics Medical
Cardiovascular · 136d
Cleared Dec 09, 2022
120V Neptune S Rover (0711-001-000)
K222552 · JCX
Stryker Instruments
General & Plastic Surgery · 108d
Cleared Dec 09, 2022
Stryker Cutomized Mandible Recon Plate
K222650 · JEY
Stryker Craniomaxillofacial (Cmf)
Dental · 99d
Cleared Dec 09, 2022
SeaSpine 7D Navigation Instruments
K222753 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 88d
Cleared Dec 09, 2022
US 450 Diode Laser Equipment
K222916 · GEX
Beijing Globalipl Development Co., Ltd.
General & Plastic Surgery · 74d
Cleared Dec 09, 2022
AIROS 8P Sequential Compression Device
K223193 · JOW
Airos Medical, Inc.
Cardiovascular · 57d
Cleared Dec 09, 2022
AIROS 6P Sequential Compression Device
K223195 · JOW
Airos Medical, Inc.
Cardiovascular · 57d
Cleared Dec 09, 2022
CELLO II Balloon Guide Catheter
K223275 · QJP
Fuji Systems Corporation
Neurology · 46d
Cleared Dec 09, 2022
HemosIL von Willebrand Factor Antigen
K223402 · GGP
Instrumentation Laboratory CO
Hematology · 30d
Cleared Dec 09, 2022
LIAISON Anti-HAV
K223403 · LOL
DiaSorin, Inc.
Microbiology · 30d
Cleared Dec 08, 2022
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer,...
K211800 · LGZ
Quality IN Flow , Ltd.
General Hospital · 546d