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
10873–10896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2023
Viz AAA
K223443 · QFM
Viz. Ai, Inc.
Radiology · 123d
Cleared Mar 17, 2023
InThrill Thrombectomy System
K223613 · QEW
Inari Medical, Inc.
Cardiovascular · 102d
Cleared Mar 17, 2023
Ablacath™ Mapping Catheter
K223666 · MTD
Ablacon, Inc.
Cardiovascular · 100d
Cleared Mar 17, 2023
Aevumed RAPID Suture Anchors
K223878 · MBI
Aevumed, Inc.
Orthopedic · 80d
Cleared Mar 17, 2023
Denture Base Resin
K230115 · EBI
Aidite (Qinhuangdao) Technology Co.,...
Dental · 59d
Cleared Mar 17, 2023
LOQTEQ® VA Elbow Plates 2.7/3.5 System
K230141 · HRS
Aap Implantate AG
Orthopedic · 58d
Cleared Mar 17, 2023
Arthrex 3.9 mm SwiveLock Anchor
K230435 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Mar 17, 2023
EMPOWR Stem Extender, 50mm
K230441 · JWH
Encore Medical, L.P Dba Enovis
Orthopedic · 24d
Cleared Mar 16, 2023
Sterile Silver Alginate Wound Dressing
K220673 · FRO
Qingdao Bright Moon Biomedical...
General & Plastic Surgery · 374d
Cleared Mar 16, 2023
Ensmile
K222619 · NXC
Ensmile Pvt, Ltd.
Dental · 198d
Cleared Mar 16, 2023
Nitrile Examination Gloves
K222813 · LZA
Ecoglove Medical Manufacturing...
General Hospital · 178d
Cleared Mar 16, 2023
iSyncBrain©-C
K222838 · OLU
iMediSync, Inc.
Neurology · 177d
Cleared Mar 16, 2023
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System,...
K222839 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 177d
Cleared Mar 16, 2023
MilkMate Breast Pump
K223084 · HGX
Milkmate Products, Inc.
Obstetrics & Gynecology · 167d
Cleared Mar 16, 2023
Senhance Surgical System
K223095 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 167d
Cleared Mar 16, 2023
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...
K223154 · OBP
Magstim Company, Ltd.
Neurology · 161d
Cleared Mar 16, 2023
Electric Wheelchair
K223393 · ITI
Shanghai Bangbang Robotics Co., Ltd.
Physical Medicine · 128d
Cleared Mar 16, 2023
BENCOX Delta Option Heads
K223828 · LZO
Corentec Co., Ltd.
Orthopedic · 85d
Cleared Mar 16, 2023
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
K230404 · PCH
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Mar 15, 2023
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
K214001 · PHX
Biomet Manufacturing Corp
Orthopedic · 449d
Cleared Mar 15, 2023
APEX 6
K220122 · GXD
Rf Innovations, Inc.
Neurology · 421d
Cleared Mar 15, 2023
Precice Intramedullary Limb Lengthening System
K220234 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 412d
Cleared Mar 15, 2023
Digital Routines
K221924 · NDC
Gnc Holdings, LLC
Chemistry · 257d
Cleared Mar 15, 2023
NeuroBlate Fusion-S Software V3.17
K222983 · GEX
Monteris Medical,
Neurology · 168d