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
30505–30528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2016
PleuraFlow System with FlowGlide
K163139 · OTK
Clearflow, Inc.
General & Plastic Surgery · 21d
Cleared Nov 29, 2016
Medline ENFit Syringe
K160642 · PIF
Medline Industries, Inc.
Gastroenterology & Urology · 267d
Cleared Nov 29, 2016
Well Lead Extraction Bag
K160801 · GCJ
Well Lead Medical Co., Ltd.
General & Plastic Surgery · 251d
Cleared Nov 29, 2016
InnoSEAL Hemostatic Pad
K161013 · QSY
Innotherapy, Inc.
General & Plastic Surgery · 232d
Cleared Nov 29, 2016
Lenstec LC Injection system
K161776 · MSS
Lenstec, Inc.
Ophthalmic · 153d
Cleared Nov 29, 2016
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
K162414 · GKZ
Beckman Coulter, Inc.
Hematology · 92d
Cleared Nov 29, 2016
LuminScan (TM) Imaging System
K162466 · NQQ
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 88d
Cleared Nov 29, 2016
TxRx Knee 15 Flare MR Coil 3.0T
K163066 · MOS
Quality Electrodynamics, LLC
Radiology · 27d
Cleared Nov 28, 2016
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
K160530 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 277d
Cleared Nov 28, 2016
Carriere Motion Clear Class II
K160720 · DYW
Ortho Organizers, Inc.
Dental · 257d
Cleared Nov 28, 2016
Powder Free Polychloroprene Examination Glove Blue, Powder Free...
K161932 · LZA
Terang Nusa Sdn Bhd
General Hospital · 137d
Cleared Nov 28, 2016
VAMP Venous/Arterial Blood Management Protection System
K161962 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 133d
Cleared Nov 28, 2016
AccuFit Lateral Plate System
K162211 · KWQ
Precision Spine, Inc.
Orthopedic · 112d
Cleared Nov 28, 2016
Solana HSV 1+2/VZV Assay
K162451 · PGI
Quidel Corporation
Microbiology · 88d
Cleared Nov 28, 2016
Filtek One Bulk Fill Restorative
K163207 · EBF
3M Company
Dental · 13d
Cleared Nov 25, 2016
NNR06 Multi-Purpose Solution
K161819 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 147d
Cleared Nov 25, 2016
Vantage Galan 3T, MRT-3020, V4.0
K162183 · LNH
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Nov 23, 2016
GAP ENDO-EXO MEDULLARY SYSTEM
K160545 · HSB
Pega Medical, Inc.
Orthopedic · 271d
Cleared Nov 23, 2016
Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
K160705 · NEW
Y. Jacobs Medical, Inc.
General & Plastic Surgery · 254d
Cleared Nov 23, 2016
PolyPlex Wound Dressing
K160872 · FRO
Global Health Solutions, LLC
General & Plastic Surgery · 238d
Cleared Nov 23, 2016
Masimo Disposable Transflectance Forehead Sensor
K160940 · DQA
Masimo Corporation
Anesthesiology · 233d
Cleared Nov 23, 2016
TRIGEN Low Profile Bone Screws
K161264 · HSB
Smith & Nephew, Inc.
Orthopedic · 202d
Cleared Nov 23, 2016
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
K161696 · HRS
Aap Implantate AG
Orthopedic · 156d
Cleared Nov 23, 2016
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K161863 · KWS
Stryker GmbH
Orthopedic · 140d