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
4777–4800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2025
QIAstat-Dx GI Panel 2 Mini B&V
K243813 · PCH
QIAGEN GmbH
Microbiology · 28d
Cleared Jan 08, 2025
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
K243644 · JFB
Ceragem Co., Ltd.
Physical Medicine · 43d
Cleared Jan 08, 2025
ANNE View, Central Hub
K242842 · MSX
Sibel Health, Inc.
Cardiovascular · 111d
Cleared Jan 08, 2025
ACE Cannula
K242741 · FMI
Ace Medical Industry Co., Ltd.
General Hospital · 119d
Cleared Jan 08, 2025
TRI-matrix® X-Force Implants
K242661 · DZE
Tri Dental Implants Int. AG
Dental · 126d
Cleared Jan 08, 2025
DormoTech NLab
K242290 · MNR
Dormotech Medical, Ltd.
Neurology · 159d
Cleared Jan 08, 2025
Sperm Freezing Medium
K242043 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 180d
Cleared Jan 08, 2025
Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
K241806 · QOF
Life Technologies Corporation
Microbiology · 201d
Cleared Jan 08, 2025
ReminGel
K241489 · LBH
Inter-Med, Inc.
Dental · 229d
Cleared Jan 08, 2025
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003 · NHA
Hiossen, Inc.
Dental · 271d
Cleared Jan 08, 2025
Electrical Scooter, WT-T4SU
K240590 · INI
W'U'S Tech Co., Ltd.
Physical Medicine · 313d
Cleared Jan 07, 2025
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K243335 · LNH
Canon Medical Systems Corporation
Radiology · 75d
Cleared Jan 07, 2025
MASADA Modular Spinal Fixation System
K243259 · NKB
Astura Medical
Orthopedic · 84d
Cleared Jan 07, 2025
COREPASS Modular Microcatheter (FLEX)
K242588 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 130d
Cleared Jan 07, 2025
GXR-Series Diagnostic X-Ray System
K242019 · KPR
DRGEM Corporation
Radiology · 181d
Cleared Jan 07, 2025
ApolloHipX (THR.SS.0001)
K241808 · LLZ
Corin U.S.A. Limited
Radiology · 200d
Cleared Jan 07, 2025
GlutenID Celiac Genetic Health Risk Test
K241456 · PTA
Targeted Genomics, LLC
Immunology · 230d
Cleared Jan 07, 2025
uCT 780
K241079 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 06, 2025
TMINI Miniature Robotic System
K243481 · OLO
THINK Surgical, Inc.
Orthopedic · 59d
Cleared Jan 06, 2025
Conformity Stem Extension Line, #0
K243466 · LZO
United Orthopedic Corporation
Orthopedic · 59d
Cleared Jan 06, 2025
WHILL Model R
K242760 · INI
Whill, Inc.
Physical Medicine · 116d
Cleared Jan 06, 2025
SD TL Implant System
K242753 · DZE
Arum Dentistry Co., Ltd.
Dental · 116d
Cleared Jan 06, 2025
Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
K242499 · KPR
Shenzhen?Sontu?Medical?Imaging?Equipm...
Radiology · 137d
Cleared Jan 06, 2025
Soteria E-View
K242488 · JAA
Omega Medical Imaging, LLC
Radiology · 138d