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
15121–15144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2022
Stern Fix Sternal Stabilization System
K211613 · JDQ
Neos Surgery S.L
Orthopedic · 238d
Cleared Jan 19, 2022
Biotres
K211709 · MWJ
Biotricity
Cardiovascular · 230d
Cleared Jan 19, 2022
Follicle Clarity
K212012 · QIH
Cycle Clarity
Radiology · 205d
Cleared Jan 19, 2022
MDx-Chex for BCID2
K212576 · PMN
Streck, Inc.
Microbiology · 156d
Cleared Jan 19, 2022
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
K212581 · HRS
Stryker GmbH
Orthopedic · 156d
Cleared Jan 19, 2022
Celeris, Disposable Sinus Debrider
K212650 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 149d
Cleared CT Jan 19, 2022
GLOBAL ICON Stemless Shoulder System
K212683 · PKC
Depuy(Ireland)
Orthopedic · 148d
Cleared Jan 19, 2022
Disposable Medical Mask
K212826 · FXX
Jiangsu Nanfang Medical Co., Ltd.
General Hospital · 138d
Cleared Jan 19, 2022
Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
K213227 · LZA
Uweport, LLC
General Hospital · 112d
Cleared Jan 19, 2022
Jabra Enhance Plus
K213424 · QDD
GN Hearing A/S
Ear, Nose, Throat · 90d
Cleared Jan 19, 2022
3D Bolus Software Application, 3D Brachy Software Application,...
K213438 · MUJ
Adaptiiv
Radiology · 89d
Cleared Jan 19, 2022
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
K213447 · OAP
Shenzhen Cosbeauty Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Jan 19, 2022
CoreLink Navigation Instruments
K214059 · OLO
Corelink, LLC
Orthopedic · 23d
Cleared Jan 18, 2022
CHIRANA Insulin Syringes
K201044 · FMF
Chirana T. Injecta
General Hospital · 637d
Cleared Jan 18, 2022
Medical Face Mask
K210679 · FXX
Wuxi Yushou Medical Appliances Co., Ltd.
General Hospital · 316d
Cleared Jan 18, 2022
HP458E Electrically Powered Wheelchair
K212503 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 162d
Cleared Jan 18, 2022
Air compression leg massager HY-1117A
K212713 · IRP
Xiamen High Top Electronic Technology...
Physical Medicine · 145d
Cleared Jan 18, 2022
Microvolume Luer Access Device
K212842 · FPA
B.Braun Medical, Inc.
General Hospital · 133d
Cleared Jan 18, 2022
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
K213216 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 111d
Cleared Jan 18, 2022
JuniOrtho Plating System™
K213572 · HWC
Orthofix Srl
Orthopedic · 69d
Cleared Jan 18, 2022
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
K213781 · MBH
Depuy Ireland UC
Orthopedic · 46d
Cleared Jan 17, 2022
Medical Face Mask
K212994 · FXX
Guangzhou Quantum Laser Intelligent...
General Hospital · 119d
Cleared Jan 16, 2022
Disposable Medical Face Mask
K211833 · FXX
Zhejiang the Purples Protective...
General Hospital · 216d
Cleared Jan 16, 2022
SIGNA Prime
K211980 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 205d