FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
28801–28824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2017
Cure™ Lumbar Plate System
K171538 · KWQ
Meditech Spine, LLC
Orthopedic · 21d
Cleared Jun 15, 2017
Axiom PX
K161177 · DZE
Anthogyr Sas
Dental · 415d
Cleared Jun 15, 2017
AccuPoint Electrode
K162459 · GZL
Microprobes For Life Science, Inc....
Neurology · 286d
Cleared Jun 15, 2017
Aptima Herpes Simplex Viruses 1 & 2 Assay
K162673 · OQO
Hologic, Inc.
Microbiology · 262d
Cleared Jun 15, 2017
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
K162749 · FDS
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 258d
Cleared Jun 15, 2017
Encore Neutral
K162826 · FPA
Rymed Technologies, LLC
General Hospital · 251d
Cleared Jun 15, 2017
Merit Coronary Control Syringe
K163084 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 224d
Cleared Jun 15, 2017
Katalyst Cyclophotocoagulation Probe
K163632 · LQJ
Katalyst Surgical, LLC
Ophthalmic · 175d
Cleared Jun 15, 2017
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves,...
K170198 · KGO
Cardinal Health, Inc.
General Hospital · 143d
Cleared Jun 15, 2017
AcuNav Diagnostic Ultrasound Catheter 8F,10F
K170263 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 139d
Cleared Jun 15, 2017
BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base,...
K170288 · MBH
Microport Orthopedics, Inc.
Orthopedic · 136d
Cleared Jun 15, 2017
sensiLift
K170499 · PAY
El Global Trade, Ltd.
General & Plastic Surgery · 118d
Cleared Jun 15, 2017
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K170569 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 108d
Cleared Jun 15, 2017
HydroMARK Breast Biopsy Site Markers
K170803 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jun 15, 2017
ATTUNE Cemented Tibial Base, Fixed Bearing
K170806 · JWH
Depuy(Ireland)
Orthopedic · 90d
Cleared Jun 15, 2017
SIMPLANT Guide
K170849 · NDP
Dentsply Sirona
Dental · 85d
Cleared Jun 15, 2017
Alma Q
K170850 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 85d
Cleared Jun 15, 2017
AcuNav V 10F Ultrasound Catheter
K170992 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 73d
Cleared Jun 15, 2017
TroClose1200, TroClose1200 Cannula
K171494 · GAM
Gordian Surgical, Ltd.
General & Plastic Surgery · 24d
Cleared Jun 14, 2017
Howell Biliary Introducer Needle
K160890 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 440d
Cleared Jun 14, 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl...
K161216 · DJG
Immunalysis Corporation
Toxicology · 411d
Cleared Jun 14, 2017
Follicle Aspiration Set
K161970 · MQE
Vitrolife Sweden AB
Obstetrics & Gynecology · 331d
Cleared Jun 14, 2017
iTotal® Hip Replacement System
K162719 · LPH
Conformis, Inc.
Orthopedic · 258d
Cleared Jun 14, 2017
UltraScore Focused Force PTA Balloon
K163420 · PNO
Bard Peripheral Vascular, Inc.
Cardiovascular · 190d