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
29569–29592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2017
nuance UNIVERSAL
K162967 · EBF
Den-Mat Holdings, LLC
Dental · 151d
Cleared Mar 24, 2017
Veloxion System
K162979 · FJL
Corinth Medtech, Inc.
Gastroenterology & Urology · 149d
Cleared Mar 24, 2017
GoSpiro
K163249 · BZG
Monitored Therapeutics, Inc.
Anesthesiology · 126d
Cleared Mar 24, 2017
NITRILE EXAMINATION GLOVE
K163267 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 123d
Cleared Mar 24, 2017
INFINITT ULite
K163290 · LLZ
Infinitt Co., Ltd.
Radiology · 122d
Cleared Mar 24, 2017
Scan&GO
K163297 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Mar 24, 2017
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand...
K163425 · HRS
Narang Medical USA Corporation
Orthopedic · 108d
Cleared Mar 24, 2017
NuVasive CoRoent Small Interbody System
K163491 · ODP
Nu Vasive, Incorporated
Orthopedic · 102d
Cleared Mar 24, 2017
VERIFY Incubator for Assert Self Contained Biological Indicators
K163587 · OWP
STERIS Corporation
General Hospital · 94d
Cleared Mar 24, 2017
FFR Link, FFR Signal Processing Module
K170204 · DRG
Boston Scientific Corporation
Cardiovascular · 60d
Cleared Mar 24, 2017
Basic, Dominant Flex
K170329 · QPB
Modela AG
General & Plastic Surgery · 50d
Cleared Mar 24, 2017
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
K170335 · HQD
Valley Contax, Inc.
Ophthalmic · 50d
Cleared Mar 24, 2017
GEN_2 and GEN_3 Mechanical Wheelchairs
K170701 · IOR
Free Wheelchair Mission
Physical Medicine · 16d
Cleared Mar 23, 2017
PerfectSmooth
K161428 · OHT
Shen Zhen Cosbeauty Co., Ltd.
General & Plastic Surgery · 304d
Cleared Mar 23, 2017
Eclipse with VEMP
K162037 · GWJ
Interacoustics A/S
Neurology · 244d
Cleared Mar 23, 2017
LOYON
K162217 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 227d
Cleared Mar 23, 2017
Tranberg CLS Diffusor Laser Fiber
K163103 · GEX
Clinical Laserthermia Systems, AB
General & Plastic Surgery · 136d
Cleared Mar 23, 2017
Medtronic Legend Pneumatic
K163182 · HBB
Medtronic Powered Surgical Solutions
Neurology · 129d
Cleared Mar 23, 2017
Guidezilla II Guide Extension Catheter
K163314 · DQY
Boston Scientific Corporation
Cardiovascular · 120d
Cleared Mar 23, 2017
Synapsys Ulmer Video Nystagmograph
K163558 · GWN
Synapsys SA
Neurology · 94d
Cleared Mar 23, 2017
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
K170277 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 52d
Cleared Mar 22, 2017
ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
K161141 · PNR
Pentaferte Italia S.R.L.
Gastroenterology & Urology · 334d
Cleared Mar 22, 2017
ENFit enteral syringe
K161979 · PNR
Jiangyin Caina Technology Co., Ltd.
Gastroenterology & Urology · 247d
Cleared Mar 22, 2017
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential...
K163017 · LZC
Gmp Medicare Sdn. Bhd.
General Hospital · 145d