FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2449–2472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2025
Portable oxygen concentrator (JAY-1000P)
K243833 · CAW
Longfian Scitech Co., Ltd.
Anesthesiology · 290d
Cleared Sep 26, 2025
Radial Jaw 4 Pulmonary Biopsy Forceps
K252921 · BWH
Boston Scientific Corporation
Anesthesiology · 14d
Cleared Sep 26, 2025
Optima Coil System (Optima Packing Coil System)
K252700 · HCG
Balt USA, LLC
Neurology · 30d
Cleared Sep 26, 2025
Magnetic Surgical System
K252435 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 56d
Cleared Sep 26, 2025
Inset Reverse Total Shoulder System
K252221 · PHX
Shoulder Innovations, Inc.
Orthopedic · 72d
Cleared Sep 26, 2025
Ligence Heart
K252105 · QIH
Ligence Uab
Radiology · 85d
Cleared Sep 26, 2025
AUXILIARY WATER TUBE MAJ-855
K251986 · OCX
Olympus Medical Systems Corporation
Gastroenterology & Urology · 91d
Cleared Sep 26, 2025
Thulium Laser System (Deluxlase)
K251919 · GEX
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 95d
Cleared Sep 26, 2025
Self-Propelled CT Scan Base Kit, CGBA-035A
K251645 · JAK
Canon Medical Systems Corporation
Radiology · 120d
Cleared Sep 26, 2025
VitalStream ART Connect
K251275 · DXG
Caretaker Medical
Cardiovascular · 155d
Cleared Sep 26, 2025
S.I.N. Dental Implant System
K251262 · DZE
S.I.N. Implant System Ltda
Dental · 156d
Cleared Sep 26, 2025
Tuned Self-Fitting Mobile App
K251208 · SCR
Tuned , Ltd.
Ear, Nose, Throat · 161d
Cleared Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
K251204 · FDA
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 161d
Cleared Sep 26, 2025
LoFric Origo
K250659 · EZD
Wellspect AB
Gastroenterology & Urology · 205d
Cleared Sep 26, 2025
Planmed XFI
K250318 · SFV
Planmed OY
Radiology · 234d
Cleared Sep 26, 2025
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K250093 · BZQ
Linshom Medical, Inc.
Anesthesiology · 255d
Cleared Sep 25, 2025
Stem Extension Line (U2 Total Knee System—PSA Type)
K252725 · JWH
United Orthopedic Corporation
Orthopedic · 28d
Cleared Sep 25, 2025
uMR 680
K252371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Sep 25, 2025
Alinity m HCV
K252102 · MZP
Abbott Molecular, Inc.
Microbiology · 84d
Cleared Sep 25, 2025
Medical Diode Laser Systems (BERYLAS-12N)
K252063 · GEX
Wuhan Dimed Laser Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Sep 25, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252062 · JWY
Thermo Fisher Scientific
Microbiology · 86d
Cleared Sep 25, 2025
EnSite™ X EP System
K252013 · DQK
Abbott Medical
Cardiovascular · 90d
Cleared Sep 25, 2025
Single-Use Biopsy Valve (MAJ-1555)
K251997 · OCX
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared Sep 25, 2025
Panther Fusion GI Expanded Bacterial Assay
K251993 · PCH
Hologic, Inc.
Microbiology · 90d