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
24217–24240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Dec 11, 2018
Precision1
K182902 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 56d
Cleared Dec 11, 2018
Invacare TDX SP2-HD with Captain's Seat
K182946 · ITI
Invacare Corporation
Physical Medicine · 49d
Cleared Dec 11, 2018
Intuitive Surgical Vessel Sealer Extend
K183107 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 33d
Cleared Dec 11, 2018
OpenLoc-L Spinal Fixation System
K183168 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 25d
Cleared Dec 11, 2018
Magma Spark Pro (Magma Spark Plus, Alpha)
K183307 · GEX
Formatk Systems , Ltd.
General & Plastic Surgery · 13d
Cleared Dec 10, 2018
reSET-O
K173681 · PWE
Pear Therapeutics, Inc.
Neurology · 374d
Cleared Dec 10, 2018
Procellera Composite Antibacterial Wound Dressing
K180533 · FRO
Vomaris Wound Care, Inc.
General & Plastic Surgery · 285d
Cleared Dec 10, 2018
CATSmart
K180831 · CAC
Fresenius Kabi AG
Cardiovascular · 255d
Cleared Dec 10, 2018
LUTRONIC GENIUS Radiofrequency System
K180945 · GEI
Lutronic Corporation
General & Plastic Surgery · 243d
Cleared Dec 10, 2018
Hailie Sensor
K181405 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 195d
Cleared Dec 10, 2018
X-ray Imaging System for the McLaren Proton Treatment System
K181498 · LHN
Ehmetdx, LLC
Radiology · 186d
Cleared Dec 10, 2018
FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
K181675 · PTC
Taidoc Technology Corporation
Chemistry · 168d
Cleared Dec 10, 2018
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
K181766 · LON
bioMerieux, Inc.
Microbiology · 160d
Cleared Dec 10, 2018
Glenoid Polyaxial Non-locking Screws
K181826 · PHX
Medacta International S.A.
Orthopedic · 154d
Cleared Dec 10, 2018
Disposable Temperature Probe
K181967 · FLL
Shenzhen Launch Electrical Co., Ltd.
General Hospital · 140d
Cleared Dec 10, 2018
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K182038 · JFY
Yd Diagnostics Corporation
Chemistry · 133d
Cleared Dec 10, 2018
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision...
K182075 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 131d
Cleared Dec 10, 2018
ARK Tramadol Assay
K182280 · DJG
ARK Diagnostics, Inc.
Toxicology · 110d
Cleared Dec 10, 2018
Applanation tonometer AT-2
K182491 · HKY
Takagi Seiko Co., Ltd.
Ophthalmic · 90d
Cleared Dec 10, 2018
LipiScan Dynamic Meibomian Imager
K182506 · HKI
Tearscience, Inc.
Ophthalmic · 89d
Cleared Dec 10, 2018
Route 92 Medical Delivery Catheter
K182512 · DQY
Route 92 Medical, Inc.
Neurology · 89d
Cleared Dec 10, 2018
Lucent® XP
K182584 · MAX
Spinal Elements, Inc.
Orthopedic · 81d
Cleared Dec 10, 2018
CelerityTM 10 STEAM Chemical Indicator
K182724 · JOJ
STERIS Corporation
General Hospital · 73d
Cleared Dec 10, 2018
Distal Radius Plating System
K182810 · HRS
Miami Device Solutions, LLC
Orthopedic · 68d