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
26017–26040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2018
Medtronic Confida Brecker Guidewire
K181001 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 17d
Cleared May 02, 2018
Lite
K172409 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 266d
Cleared May 02, 2018
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with...
K172864 · LZC
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 224d
Cleared May 02, 2018
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
K173653 · PGX
Alere Scarborough, Inc.
Microbiology · 155d
Cleared May 02, 2018
Accu O2 Oxygen Analyzer
K173807 · CCL
Precision Medical, Inc.
Anesthesiology · 138d
Cleared May 02, 2018
MC 300R* Nebulizer
K173825 · CAF
Trudell Medical International
Anesthesiology · 135d
Cleared May 02, 2018
Drug Relief
K173861 · PZR
Dyansys, Inc.
Neurology · 133d
Cleared May 02, 2018
ADAPT for Gamma3
K173946 · OLO
Stryker GmbH
Orthopedic · 126d
Cleared May 02, 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
K180028 · EZN
Cook Incorporated
Gastroenterology & Urology · 119d
Cleared May 02, 2018
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K180264 · LSR
Gold Standard Diagnostics
Microbiology · 92d
Cleared May 02, 2018
7D Surgical System
K180352 · OLO
7D Surgical, Inc.
Orthopedic · 83d
Cleared May 02, 2018
Venue
K180599 · IYN
GE Medical Systems Ultrasound and...
Radiology · 56d
Cleared May 02, 2018
Spineology Navigation Instruments
K180796 · OLO
Spineology, Inc.
Orthopedic · 36d
Cleared May 01, 2018
BacterioScan 216Dx System
K172412 · QBQ
Bacterioscan, Inc.
Microbiology · 264d
Cleared May 01, 2018
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial...
K172554 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 250d
Cleared May 01, 2018
SAPPHIRE, ELEVARE SAPPHIRE
K172555 · OLP
Omm Imports, Inc. D/B/A Zero Gravity
General & Plastic Surgery · 250d
Cleared May 01, 2018
BiliLux
K172656 · LBI
Draeger Medical Systems, Inc.
General Hospital · 238d
Cleared May 01, 2018
PeraServer and PeraTrend
K172959 · MWI
Perahealth, Inc.
Cardiovascular · 217d
Cleared May 01, 2018
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage...
K173035 · FGE
Cook Incorporated
Gastroenterology & Urology · 215d
Cleared May 01, 2018
ViaTherm BOOST
K173300 · IMJ
Viatherm Therapeutics, LLC
Physical Medicine · 196d
Cleared May 01, 2018
Liberty Cycler Set
K173718 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 147d
Cleared May 01, 2018
AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
K180848 · GEI
ArthroCare Corporation
General & Plastic Surgery · 29d
Cleared Apr 30, 2018
Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg,...
K171678 · CCK
Vyaire Medical, Inc.
Anesthesiology · 328d
Cleared Apr 30, 2018
VitaMESH Macroporous PP Surgical Mesh
K172636 · FTL
Proxy Biomedical , Ltd.
General & Plastic Surgery · 241d