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
18577–18600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2020
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD...
K203120 · GAS
Lsi Solutions, Inc.
General & Plastic Surgery · 39d
Cleared Nov 23, 2020
Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308,...
K193621 · FLL
Dongguan E-Test Technology Co., Ltd.
General Hospital · 333d
Cleared Nov 23, 2020
Mirus Ligating Clip, Mirus Ligating Clip Applier
K200166 · FZP
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 306d
Cleared Nov 23, 2020
Somnos Anti-Snoring Mouth Guard
K201484 · LRK
Koncept Innovators, LLC
Dental · 172d
Cleared Nov 23, 2020
Medical surgical mask
K201991 · FXX
Shenzhen Everwin Precision Technology...
General Hospital · 129d
Cleared Nov 23, 2020
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
K202475 · LOD
Heraeus Medical GmbH
Orthopedic · 87d
Cleared Nov 23, 2020
Confirm Rx Insertable Cardiac Monitor
K202888 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 56d
Cleared Nov 23, 2020
Invictus™ Spinal Fixation System
K203056 · NKB
Alphatec Spine, Inc.
Orthopedic · 46d
Cleared Nov 22, 2020
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons /...
K202090 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 117d
Cleared Nov 20, 2020
Puritan Bennett 980 Series Ventilator System
K193056 · CBK
Covidien, LLC
Anesthesiology · 385d
Cleared Nov 20, 2020
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
K193191 · BTL
Weinmann Emergency Medical Technology...
Anesthesiology · 367d
Cleared Nov 20, 2020
V-ONESTEP
K193285 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 359d
Cleared Nov 20, 2020
CorInsights MRI
K193287 · LLZ
Adm Diagnostics, Inc.
Radiology · 359d
Cleared Nov 20, 2020
Codman Surgical Patties & Strips
K193346 · HBA
Integra LifeSciences Corporation
Neurology · 353d
Cleared CT Nov 20, 2020
Solitaire Platinum Revascularization Device, Solitaire X Revascularization...
K193576 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 333d
Cleared Nov 20, 2020
HALO
K200873 · QAS
Nico-Lab B.V.
Radiology · 233d
Cleared Nov 20, 2020
NeuroStar Advanced Therapy
K201158 · OBP
Neuronetics, Inc.
Neurology · 204d
Cleared Nov 20, 2020
Optomed Smartscope M5 with Optomed Smartscope FA
K201325 · HKI
Optomed Oyj
Ophthalmic · 186d
Cleared Nov 20, 2020
Passio Pump Drainage System
K201404 · DWM
Bearpac Medical
Anesthesiology · 176d
Cleared Nov 20, 2020
TIPCAM1 Rubina Video Endoscope System
K201526 · GCJ
Karl Storz Endoscopy America
Obstetrics & Gynecology · 165d
Cleared Nov 20, 2020
Dornier MAGELLAN Ureteral Access Sheath
K201815 · FED
Dornier Medtech America, Inc.
Gastroenterology & Urology · 142d
Cleared Nov 20, 2020
MiniCAT 2D
K201825 · KPR
Xoran Technologies, LLC
Radiology · 141d
Cleared Nov 20, 2020
MPS 3 ND Myocardial Protection System
K201984 · DTR
Quest Medical, Inc.
Cardiovascular · 126d
Cleared Nov 20, 2020
Silatrix Oral Gel
K202000 · OLR
Sa3, LLC
General & Plastic Surgery · 123d