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
24481–24504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2018
ELAN 4 Air Motor System
K172907 · HBB
Aesculap, Inc.
Neurology · 410d
Cleared CT Nov 09, 2018
EZ-IO Intraosseous Vascular Access System
K180395 · FMI
Arrow International, Inc. (Subsidiary...
General Hospital · 269d
Cleared Nov 09, 2018
FilmArray Pneumonia Panel
K180966 · QDP
Biofire Diagnostics, LLC
Microbiology · 210d
Cleared Nov 09, 2018
Cryotop®US-flash and Cryotop®US-scoop
K181469 · MQK
Kitazato Corporation
Obstetrics & Gynecology · 158d
Cleared Nov 09, 2018
Neurosign V4 Intraoperative Nerve Monitor
K181559 · PDQ
Magstim Company, Ltd.
Neurology · 149d
Cleared Nov 09, 2018
PowerDot PD-01MT
K181759 · IPF
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 130d
Cleared Nov 09, 2018
Brainlab Compatible K2M Navigation Instruments
K181890 · OLO
K2m
Orthopedic · 119d
Cleared Nov 09, 2018
Heat Pain Pro
K181992 · NUH
Omron Healthcare, Inc.
Neurology · 106d
Cleared Nov 09, 2018
Catalys Precision Laser System
K182083 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 99d
Cleared Nov 09, 2018
Arco™-SA Lumbar Cage System
K182195 · OVD
Neurostructures, Inc.
Orthopedic · 87d
Cleared Nov 09, 2018
Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · DYW
Blue Sky Bio
Dental · 73d
Cleared Nov 09, 2018
Teleport Microcatheter
K182360 · DQY
Orbusneich Medical Trading, Inc.
Cardiovascular · 71d
Cleared Nov 09, 2018
HEM-6410T-ZM Wrist Blood Pressure Monitor
K182481 · DXN
Omron Healthcare, Inc.
Cardiovascular · 60d
Cleared Nov 09, 2018
VERITON CT whole body SPECT/CT system
K182484 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 59d
Cleared Nov 09, 2018
BIOEASY Multi-Drug Test Cup
K182530 · NFT
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 56d
Cleared Nov 09, 2018
AtriCure cryoICE cryoSPHERE cryoablation probe
K182565 · GXH
AtriCure, Inc.
Neurology · 52d
Cleared Nov 09, 2018
Enteral Feeding Syringes with Enfit Connectors
K182649 · PNR
Jiangsu Kangbao Medical Equipment...
Gastroenterology & Urology · 46d
Cleared Nov 09, 2018
Aspida® Anterior Lumbar Plating System
K182808 · KWQ
Alphatec Spine, Inc.
Orthopedic · 37d
Cleared Nov 09, 2018
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ...
K182857 · IYN
Philips Ultrasound, Inc.
Radiology · 30d
Cleared Nov 08, 2018
neoClose PDS
K173917 · GCJ
Neosurgical, Ltd.
General & Plastic Surgery · 321d
Cleared Nov 08, 2018
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K180047 · FLL
Fiab Spa
General Hospital · 304d
Cleared Nov 08, 2018
Silk Voice
K180631 · MIX
Sofregen Medical, Inc.
Ear, Nose, Throat · 244d
Cleared Nov 08, 2018
MiroCam Capsule Endoscope System
K180732 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 233d
Cleared Nov 08, 2018
Steribite
K180949 · HAE
Rjr Surgical, Inc.
Neurology · 211d