FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
11545–11568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2022
iFuse Bedrock Granite® Implant System
K222774 · OUR
SI-BONE, Inc.
Orthopedic · 99d
Cleared Dec 22, 2022
Kodiak C Spinal Implant System
K222806 · ODP
Met One Technologies, LLC
Orthopedic · 97d
Cleared Dec 22, 2022
Invisalign System, Pre-Formed Attachment System
K222894 · NXC
Align Technology, Inc.
Dental · 90d
Cleared Dec 22, 2022
Air Compression Leg Massager (Model: LY-670D)
K222949 · IRP
Zhejiang Luyao Electronics Technology...
Physical Medicine · 86d
Cleared Dec 22, 2022
Tesera-K SC System
K223105 · OVE
Kyocera Medical Technologies, Inc.
Orthopedic · 83d
Cleared Dec 22, 2022
Coltolux Comfort LED Curing Light
K223142 · EBZ
Dent4you AG
Dental · 79d
Cleared Dec 22, 2022
ASTRA Spine System
K223273 · NKB
Spinecraft, LLC
Orthopedic · 59d
Cleared Dec 22, 2022
Philips CT 3500
K223311 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 55d
Cleared Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · OCL
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 22, 2022
Biograph Vision Quadra PET/CT System
K223547 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 22, 2022
VERTICALE® Navigation Instruments
K223649 · OLO
Silony Medical GmbH
Orthopedic · 16d
Cleared Dec 21, 2022
CURA-Temp
K202965 · EBG
Mgnewton , Ltd.
Dental · 812d
Cleared Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K213235 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 447d
Cleared Dec 21, 2022
BiWaze Clear System
K213564 · NHJ
Abmrc, LLC
Anesthesiology · 407d
Cleared Dec 21, 2022
DRI TM Tricyclics Serum Tox Assay
K213875 · LFH
Microgenics Corporation
Toxicology · 373d
Cleared Dec 21, 2022
Comfort Gown, Safewear Gown
K213893 · FYA
Xuchang Zhengde Environstar Medical...
General Hospital · 372d
Cleared Dec 21, 2022
BresoDX1
K220012 · MNR
Bresotec, Inc.
Anesthesiology · 351d
Cleared Dec 21, 2022
ELECTROCYN soma
K220286 · FRO
V3Bio Sdn. Bhd
General & Plastic Surgery · 323d
Cleared Dec 21, 2022
CORE-INJECTOR
K221054 · FBK
Incore Co., Ltd.
Gastroenterology & Urology · 254d
Cleared Dec 21, 2022
Advanced Intramedullary Nail System
K221221 · HSB
Double Medical Technology, Inc.
Orthopedic · 238d
Cleared Dec 21, 2022
Eargo 5 , Eargo 6
K221698 · QUH
Eargo, Inc.
Ear, Nose, Throat · 191d
Cleared Dec 21, 2022
Extra Silver Gelling Fiber Dressing
K221720 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 191d
Cleared Dec 21, 2022
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
K221826 · JTN
Becton, Dickinson and Company
Microbiology · 181d
Cleared Dec 21, 2022
LimFlow Vector
K221902 · MGZ
LimFlow, Inc.
Cardiovascular · 174d