FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: 2026–2026 ×
2,517 results
1369–1392 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared May 11, 2026
KARL STORZ Trocars with Valve Seals
K254228 · GCJ
Karl Storz SE & CO. KG
General & Plastic Surgery · 136d
Cleared May 11, 2026
SAYA 86 Radial Access Guide Catheter
K254178 · QJP
Asahi Intecc Co., Ltd.
Neurology · 139d
Cleared May 11, 2026
CFlex Cystoscope - Standard Deflection (0570-0455)
K253696 · FAJ
Verathon Medical (Canada) Ulc
Gastroenterology & Urology · 171d
Cleared May 11, 2026
Velmeni for Dentists (V4D) Endo-Perio
K252953 · MYN
Velmeni, Inc.
Radiology · 237d
Cleared May 11, 2026
Pytheas Your Guided Trajectory
K252880 · OLO
Pytheas Navigation Sas
Orthopedic · 243d