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
4273–4296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2025
Vitrea CT VScore
K243240 · JAK
Canon Medical Informatics, Inc.
Radiology · 182d
Cleared Apr 10, 2025
syngo.CT LVO Detection
K243145 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 192d
Cleared Apr 10, 2025
Tesera-k SC System
K242928 · OVE
Kyocera Medical Technologies, Inc.
Orthopedic · 198d
Cleared Apr 10, 2025
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
K242561 · MQL
Donnevie Medical Technology...
Obstetrics & Gynecology · 225d
Cleared Apr 10, 2025
Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
K242089 · MQL
Jiangsu Ruifuda Medical Device Co., Ltd.
Obstetrics & Gynecology · 267d
Cleared Apr 10, 2025
Initia T3 Acetabular Hemispherical Shell System
K242045 · LPH
Kyocera Medical Technologies, Inc.
Orthopedic · 272d
Cleared Apr 09, 2025
AURORA® Surgiscope® System (ASX15/60)
K250752 · GWG
Integra LifeSciences Corporation
Neurology · 28d
Cleared Apr 09, 2025
ProLift Expandable Spacer System
K250373 · MAX
Life Spine, Inc.
Orthopedic · 58d
Cleared Apr 09, 2025
Bard Soft Mesh
K250098 · FTL
Davol, Inc.
General & Plastic Surgery · 85d
Cleared Apr 09, 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
K243966 · BZQ
Faceheart Corp.
Anesthesiology · 107d
Cleared Apr 09, 2025
Luminopia
K243819 · QQU
Luminopia, Inc.
Ophthalmic · 118d
Cleared Apr 09, 2025
autoSCORE (V 2.0.0)
K243743 · OMB
Holberg Eeg AS
Neurology · 126d
Cleared Apr 09, 2025
Patch-TEA (Model TRI-21)
K243613 · NUH
Transtimulation Research, Inc.
Neurology · 138d
Cleared Apr 09, 2025
Dexcom G7 15 Day Continuous Glucose Monitoring System
K243214 · QBJ
Dexcom, Inc.
Chemistry · 188d
Cleared Apr 09, 2025
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion...
K242429 · SEF
Becton Dickinson Inc. (Bd)
General Hospital · 237d
Cleared Apr 09, 2025
Ceribell Seizure Detection Software
K241589 · OMB
Ceribell, Inc.
Neurology · 310d
Cleared Apr 08, 2025
TriMed Fusion Cup System
K250948 · HRS
TriMed, Inc.
Orthopedic · 18d
Cleared Apr 08, 2025
NPseal
K250708 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 29d
Cleared Apr 08, 2025
Electric Wheelchair (LW01301A07)
K250366 · ITI
Anhui Longway Medical Technology Co.,...
Physical Medicine · 57d
Cleared Apr 08, 2025
LuxCreo Clear Aligner System
K250343 · NXC
LuxCreo, Inc.
Dental · 61d
Cleared Apr 08, 2025
Globalcare Blood Pressure Monitor (GUS610)
K250136 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 81d
Cleared Apr 08, 2025
ONE Nitrile Condom
K243967 · MOL
Global Protection Corp.
Obstetrics & Gynecology · 106d
Cleared Apr 08, 2025
Jmoon Conductive Gel
K243749 · GYB
Shenzhen Ulike Smart Electronics Co.,...
Neurology · 124d
Cleared Apr 08, 2025
Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001)
K243722 · OMT
Selio Medical Limited
Anesthesiology · 126d