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
769–792 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 13, 2026
Electric Breast Pump (HL-3058 II Pro)
K254125 · HGX
Fimilla (Shanghai) Maternity & Baby...
Obstetrics & Gynecology · 145d
Cleared May 13, 2026
StatSeal Disc
K254073 · FRO
Merit Medical Systems, Inc.
General & Plastic Surgery · 146d
Cleared May 13, 2026
Electric Wheelchair (Y207BL)
K253241 · ITI
Jiangsu Intco Medical Products Co., Ltd.
Physical Medicine · 226d
Cleared May 13, 2026
SURGIMAGE SIM 1000H Fluorescence Imaging Platform
K253181 · IZI
Surgimage Corporation
General & Plastic Surgery · 229d
Cleared May 13, 2026
Portable Neuromodulation Stimulator (PoNS)
K253061 · QCF
Helius Medical, Inc.
Neurology · 233d
Cleared May 13, 2026
ACIST Pro Diagnostic System (019304)
K252653 · DXT
Acist Medical Systems, Inc.
General Hospital · 264d
Cleared May 13, 2026
VeraPro S100 Multi-Use Syringe (018808)
K252638 · DXT
Acist Medical Systems, Inc.
General Hospital · 266d
Cleared May 13, 2026
Automatic Micro Needle System (CODE-X)
K252591 · QAI
Woorhi Mechatronics Co., Ltd.
General & Plastic Surgery · 271d
Cleared May 12, 2026
Promisemed VeriEcto Automatic Biopsy Needles
K261196 · KNW
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 29d
Cleared May 12, 2026
OSTEOMNI SPINAL CAGES SYSTEM
K260850 · ODP
OSTEOMNI, Inc.
Orthopedic · 57d
Cleared May 12, 2026
VersaLift Expandable System
K260837 · MAX
Life Spine, Inc.
Orthopedic · 60d
Cleared May 12, 2026
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
K260725 · FYA
Hindernis DE Mexico, S.A.P.I. DE C.V.
General Hospital · 68d
Cleared May 12, 2026
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
K260473 · BTA
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat · 89d
Cleared May 12, 2026
myLEDmask 2 (MJ-144)
K260415 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 92d
Cleared May 12, 2026
Rayvolve
K260378 · QBS
AZmed
Radiology · 96d
Cleared May 12, 2026
CellDx-Tissue
K260235 · PZM
Datar Cancer Genetics Private Limited
Pathology · 106d
Cleared May 12, 2026
CorVision® (91-205-Z0014)
K260051 · MOD
Corvent Medical, Inc.
Anesthesiology · 124d
Cleared May 12, 2026
Senhance Ultrasonic System
K254192 · NAY
Asensus Surgical
General & Plastic Surgery · 140d
Cleared May 12, 2026
Promimic ZrP Surface Dental Implant
K252731 · DZE
Promimic AB
Dental · 257d
Cleared May 11, 2026
PICO SHINING (PICO-K
K261214 · GEX
Speclipse, Inc.
General & Plastic Surgery · 27d
Cleared May 11, 2026
Diagnostic Ultrasound System (MU9)
K260846 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared May 11, 2026
HardyDisk AST Gepotidacin 10µg (GEP10)
K260842 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared May 11, 2026
Dual Core
K260805 · EBF
Vericom Co., Ltd.
Dental · 60d
Cleared May 11, 2026
ETHICON™ Circular Stapler (CDH21mm)
K260196 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 109d