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: 2026–2026 ×
1,922 results
1705–1728 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 29, 2026
Electric Scooter (DDF100)
K252275 · INI
Zhejiang Nysin Medical Co., Ltd.
Physical Medicine · 191d
Cleared Jan 29, 2026
Surgical Reality Viewer
K252091 · QIH
Medicalvr B.V.
Radiology · 210d
Cleared Jan 29, 2026
Medical Shaver System (Morcellator) (YSB-IIIA)
K251923 · GCJ
Hangzhou Hawk Optical Electronic...
Gastroenterology & Urology · 220d
Cleared Jan 29, 2026
EK MULTI ANGLED 30 ABUTMENT
K251427 · NHA
Hiossen, Inc.
Dental · 266d
Cleared Jan 29, 2026
UV Smart D60
K251354 · SCS
UV Smart Technologies B.V.
General Hospital · 274d
Cleared Jan 29, 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274 · EZD
HR Healthcare
Gastroenterology & Urology · 280d
Cleared Jan 29, 2026
Multi-Unit DAS System
K243732 · NHA
Talladium Espa?a, SL
Dental · 421d
Cleared Jan 28, 2026
Aevumed PROTEKT Suture Anchor
K260004 · MBI
Aevumed, Inc.
Orthopedic · 26d
Cleared Jan 28, 2026
Vena MicroAngioscope™ System
K253842 · LYK
Vena Medical Holdings Corp
Cardiovascular · 57d
Cleared Jan 28, 2026
Sleepiz One+ (Model 2.5)
K253388 · DRT
Sleepiz AG
Cardiovascular · 120d
Cleared Jan 28, 2026
GBT Machine Airflow Prophylaxis Master
K253254 · ELC
E.M.S Electro Medical Systems S.A
Dental · 121d
Cleared Jan 28, 2026
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
K253224 · OBH
ImpediMed Limited
Gastroenterology & Urology · 121d
Cleared Jan 28, 2026
Sacroiliac Joint Truss System (SJTS)
K252834 · OUR
4Web Medical
Orthopedic · 145d
Cleared Jan 28, 2026
HIGHERDOSE Body Sculptor (Model: GS-03)
K252603 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 163d
Cleared Jan 28, 2026
NorthStar™ Mapping System
K252164 · DQK
Imricor Medical Systems
Cardiovascular · 202d
Cleared Jan 28, 2026
FreedomEdge Infusion System
K252015 · FRN
Koru Medical Systems, Inc.
General Hospital · 215d
Cleared Jan 28, 2026
XeliteMed SuperM-Fix Spinal Bone Cement
K251896 · NDN
Xelite Biomed , Ltd.
Orthopedic · 222d
Cleared Jan 28, 2026
Hand Massager (SM004D)
K251622 · IRP
Ningbo Zhenhai Yihao Electronic...
Physical Medicine · 245d
Cleared Jan 28, 2026
Sterilization Pouch/Roll
K251347 · FRG
Sterivic Medical Co., Ltd.
General Hospital · 273d
Cleared Jan 28, 2026
Seg Pro V3 (RT-300)
K251306 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 275d
Cleared Jan 28, 2026
Mpact 3D Metal Implants Extension – DMLS Technology
K251043 · LPH
Medacta International S.A.
Orthopedic · 300d
Cleared Jan 27, 2026
Optima Coil System (OptiOne Coil System)
K254221 · HCG
Balt USA, LLC
Neurology · 29d
Cleared Jan 27, 2026
Reusable 3 Button Fingerswitch Wand
K254220 · GEI
Soniquence, LLC
General & Plastic Surgery · 29d
Cleared Jan 27, 2026
Access anti-HAV IgM
K251995 · LOL
Beckman Coulter, Inc.
Microbiology · 214d