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
24097–24120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Dec 21, 2018
vascuCAP
K183012 · LLZ
Elucid Bioimaging, Inc.
Radiology · 51d
Cleared Dec 21, 2018
3nethra neo
K183059 · HKI
Forus Health Pvt.Ltd
Ophthalmic · 49d
Cleared Dec 21, 2018
Nitrile Glove Powder Free White
K183068 · LZA
Haining Medical Products Co., Ltd.
General Hospital · 46d
Cleared Dec 21, 2018
Pulse Rx 2.0, Pulse Pro Rx 2.0
K183328 · JOW
NormaTec Industries, LP
Cardiovascular · 21d
Cleared Dec 20, 2018
AirSpiral Heated Breathing Tube
K162553 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 828d
Cleared Dec 20, 2018
3DIEMME RealGUIDE
K173041 · LLZ
3Diemme , Ltd.
Radiology · 448d
Cleared Dec 20, 2018
Natureplex Warm Touch Warming Jelly
K180828 · NUC
Natureplex, LLC
Obstetrics & Gynecology · 265d
Cleared Dec 20, 2018
Reuter Tip Deflecting Wire Guide
K180830 · DQX
Cook Incorporated
Cardiovascular · 265d
Cleared Dec 20, 2018
Curiteva Lumbar Interbody Fusion System
K181589 · MAX
Curiteva, LLC
Orthopedic · 185d
Cleared Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
K181663 · PAM
Genmark Diagnostics, Incorporated
Microbiology · 178d
Cleared Dec 20, 2018
Sinusway Dilation System
K181838 · LRC
3nt Medical , Ltd.
Ear, Nose, Throat · 163d
Cleared CT Dec 20, 2018
Embrace
K181861 · POS
Empatica S.R.L.
Neurology · 161d
Cleared Dec 20, 2018
Color Doppler Ultrasound System
K182165 · IYN
Shenzhen Well.D Medical Electronics...
Radiology · 132d
Cleared Dec 20, 2018
BD Contoured Base Pen Needle
K182320 · FMI
Becton, Dickinson and Company
General Hospital · 115d
Cleared Dec 20, 2018
ASAHI Corsair Pro XS
K182420 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 106d
Cleared Dec 20, 2018
O2 Concepts Oxlife Independence Model 301-0001
K182454 · CAW
O2 Concepts, LLC
Anesthesiology · 104d
Cleared Dec 20, 2018
FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
K182670 · MQV
Prosidyan, Inc.
Orthopedic · 86d
Cleared Dec 20, 2018
Phoenix Atherectomy System
K182972 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 55d
Cleared Dec 20, 2018
Dilator Sets
K183036 · DRE
Cook Incorporated
Cardiovascular · 49d
Cleared Dec 20, 2018
MTS Levofloxacin 0.002 - 32 µg/mL
K183115 · JWY
Liofilchem S. R. L.
Microbiology · 41d
Cleared Dec 20, 2018
microTargeting Guideline 4000 5.0 System
K183123 · GZL
FHC, Inc.
Neurology · 37d
Cleared Dec 20, 2018
DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction...
K183267 · DXT
Osprey Medical, Inc.
Cardiovascular · 27d
Cleared Dec 19, 2018
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood...
K173140 · NBW
Vivachek Laboratories, Inc.
Chemistry · 446d
Cleared Dec 19, 2018
Arterial Pressure Monitoring Set/Tray
K180846 · DQO
Cook Incorporated
Cardiovascular · 261d