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
27769–27792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2017
Stryker Spine Navigation System with SpineMap 3D software application,...
K172034 · OLO
Stryker Corporation
Orthopedic · 105d
Cleared Oct 18, 2017
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
K172203 · MLY
Nuance Medical, LLC
Physical Medicine · 89d
Cleared Oct 18, 2017
NovaCross Microcatheter
K172297 · DQY
Nitiloop , Ltd.
Cardiovascular · 79d
Cleared Oct 18, 2017
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
K172608 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 48d
Cleared Oct 18, 2017
ECG SENTINEL System
K172801 · DXH
Cardiomedix, Inc.
Cardiovascular · 30d
Cleared Oct 18, 2017
OTC Combo TENS/EMS System
K172809 · NUH
Well-Life Healthcare Limited
Neurology · 30d
Cleared Oct 18, 2017
Emit II Plus Oxycodone Assay
K172910 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 23d
Cleared Oct 18, 2017
ANCHOR Tissue Retrieval System
K172940 · GCJ
Conmed Corporation
General & Plastic Surgery · 22d
Cleared Oct 18, 2017
Curve Image 2.0 PACS
K173101 · LLZ
Curve Dental, Ltd.
Radiology · 19d
Cleared Oct 17, 2017
SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare...
K160282 · NBW
Sd Biosensor
Chemistry · 623d
Cleared Oct 17, 2017
RVS-100 Vital Signs Monitor
K170538 · MWI
Rudolf Riester GmbH
Cardiovascular · 236d
Cleared Oct 17, 2017
CERABIEN ZR
K170834 · EIH
Kuraray Noritake Dental, Inc.
Dental · 211d
Cleared Oct 17, 2017
X-SURGE
K171752 · GEI
Genicon, Inc.
General & Plastic Surgery · 126d
Cleared Oct 17, 2017
Chitogel Endoscopic Sinus Surgery Kit
K172179 · LYA
Chitogel, Ltd.
Ear, Nose, Throat · 90d
Cleared Oct 17, 2017
585
K172198 · GEX
Quanta System Spa
General & Plastic Surgery · 88d
Cleared Oct 17, 2017
EnsoETM
K172493 · PLA
Attune Medical
Cardiovascular · 60d
Cleared Oct 17, 2017
Applanation tonometer AT-1
K172728 · HKY
Takagi Seiko Co., Ltd.
Ophthalmic · 36d
Cleared Oct 17, 2017
Bencox Mirabo Cup System
K172806 · LPH
Corentec Co., Ltd.
Orthopedic · 29d
Cleared Oct 17, 2017
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS...
K172817 · FET
Olympus Medical Systems Corp.
Gastroenterology & Urology · 29d
Cleared CT Oct 16, 2017
OptiScanner 5000 Glucose Monitoring System
K162042 · LZF
Optiscan Biomedical Corp.
Chemistry · 448d
Cleared CT Oct 16, 2017
AcQMap 3D Imaging and Mapping Catheter
K170819 · MTD
Acutus Medical, Inc.
Cardiovascular · 210d
Cleared CT Oct 16, 2017
AcQMap High Resolution Imaging and Mapping System
K170948 · DQK
Acutus Medical, Inc.
Cardiovascular · 200d
Cleared Oct 16, 2017
HylaGuard Moisturizing Cream
K171879 · MGQ
Founders Science Group, LLC
General & Plastic Surgery · 115d
Cleared Oct 16, 2017
Solana RSV+hMPV Assay
K171974 · OCC
Quidel Corporation
Microbiology · 108d