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
27745–27768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2017
TREFOIL System
K172352 · DZE
Nobel Biocare AB
Dental · 78d
Cleared Oct 20, 2017
GSI Novus
K172403 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 72d
Cleared Oct 20, 2017
Discovery XR656 HD
K172869 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 30d
Cleared Oct 20, 2017
NeuroBlate System
K172881 · GEX
Monteris Medical,
General & Plastic Surgery · 29d
Cleared Oct 20, 2017
Heraeus TMW Guidewire
K173052 · DQX
Heraeus Medical Components, LLC
Cardiovascular · 22d
Cleared Oct 19, 2017
GRI-FILL PERISTALTIC SET
K162216 · LHI
Laboratorios Grifols, S.A.
General Hospital · 437d
Cleared Oct 19, 2017
Premium Plus Prophy Air Motor
K170261 · EFB
Premium Plus International Limited
Dental · 265d
Cleared Oct 19, 2017
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · CFR
Abbott Laboratories
Chemistry · 260d
Cleared Oct 19, 2017
Medrobotics Flex Robotic System
K170453 · EOB
Medrobotics Corporation
Ear, Nose, Throat · 246d
Cleared Oct 19, 2017
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT...
K170614 · NBW
I-Sens, Inc.
Chemistry · 232d
Cleared Oct 19, 2017
VICTUS Femtosecond Laser Platform
K171014 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 198d
Cleared Oct 19, 2017
audifon Tinnitus-Module
K171243 · KLW
Audiofon USA, Inc.
Ear, Nose, Throat · 174d
Cleared Oct 19, 2017
065 Zenith, 074 Zenith
K171672 · DQY
Inneuroco, Inc.
Cardiovascular · 135d
Cleared Oct 19, 2017
RPM Reinforced PTFE Mesh
K171774 · NPK
Osteogenics Biomedical, Inc.
Dental · 127d
Cleared Oct 19, 2017
Avail
K172079 · NUH
Omron Healthcare, Inc.
Neurology · 101d
Cleared Oct 19, 2017
PuRE PMMA Disc
K172281 · EBG
Quest Dental USA Corp.
Dental · 83d
Cleared Oct 19, 2017
Discovery Pico, Discovery Pico Plus
K172376 · GEX
Quanta System Spa
General & Plastic Surgery · 73d
Cleared Oct 19, 2017
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set,...
K172527 · LJE
Cook Incorporated
Gastroenterology & Urology · 59d
Cleared Oct 19, 2017
EsophyX Z, EsophyX2 HD
K172811 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 18, 2017
Liberator Beacon Tip Locking Stylet
K170298 · DRB
Cook Incorporated
Cardiovascular · 260d
Cleared Oct 18, 2017
Convaid Flyer FL12, FL13, FL14, FL15 and FL16
K171017 · IOR
Convaid Products, LLC
Physical Medicine · 196d
Cleared Oct 18, 2017
OrthoView 7.2
K171068 · LLZ
Meridian Technique, Ltd.
Radiology · 191d
Cleared Oct 18, 2017
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear...
K171125 · LPL
Tangible Science, LLC
Ophthalmic · 184d
Cleared Oct 18, 2017
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
K171579 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 140d