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
721–744 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 22, 2026
NanoZoomer S540MD Slide Scanner System
K260964 · PSY
Hamamatsu Photonics K.K.
Pathology · 121d
Cleared Jul 22, 2026
Anovo Surgical System (6Ne)
K260804 · SCV
Momentis Surgical , Ltd.
General & Plastic Surgery · 132d
Cleared Jul 22, 2026
Tornier Perform Advanced Glenoid
K260721 · KWS
Tornier, Inc.
Orthopedic · 139d
Cleared Jul 22, 2026
Ossiclear (Ossiclear System)
K254296 · LXB
Sounduct
Ear, Nose, Throat · 203d
Cleared Jul 22, 2026
STEDI Scan Device
K253840 · QAF
Stroke DX
Neurology · 233d
Cleared Jul 21, 2026
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
K262014 · LZA
O&M Halyard, Inc.
General Hospital · 36d
Cleared Jul 21, 2026
Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
K261775
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 53d
Cleared Jul 21, 2026
Medical Thulium Fiber Laser Systems (UroFiber 150Q)
K261738 · GEX
Rhein Laser Technologies Co., Ltd.
General & Plastic Surgery · 55d
Cleared Jul 21, 2026
One-Fil LC
K261728 · EJK
Mediclus Co., Ltd.
Dental · 56d
Cleared Jul 21, 2026
Versalock Proximal Tibial Plating System
K261406 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 83d
Cleared Jul 21, 2026
NOVEOS Specific IgE (sIgE)
K260591 · DHB
Hycor Biomedical
Immunology · 148d
Cleared Jul 21, 2026
ResolutionMD
K260500 · LLZ
ResolutionMD, Inc.
Radiology · 158d
Cleared Jul 21, 2026
Raney Clips Kit
K253814 · HBO
Beijing Honghugaoxiang Science and...
Neurology · 235d
Cleared Jul 21, 2026
CardIQ Suite
K253770 · JAK
GE Medical Systems SCS
Radiology · 237d
Not Cleared Jul 21, 2026
OTTAVA™ Robotic Surgical System
DEN250068 · SIR
Auris Health, Inc., part of Johnson &...
General & Plastic Surgery · 215d
Cleared Jul 20, 2026
Thunderbolt System
K261632 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 63d
Cleared Jul 20, 2026
ENDOSCOPE HOLDER (182214)
K261573 · QZB
Aktormed GmbH
General & Plastic Surgery · 69d
Cleared Jul 20, 2026
Hi-D Imaging 4TAVR
K261535 · QIH
Hi-D Imaging AG
Radiology · 73d
Cleared Jul 20, 2026
Sleep Apnea Feature (v2.0)
K261011 · QZW
Samsung Electronics Co., Ltd.
Anesthesiology · 116d
Cleared Jul 20, 2026
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C,...
K260516 · FGB
MacroLux Medical Technology Co., Ltd.
Gastroenterology & Urology · 153d
Cleared Jul 20, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K254285 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 201d
Cleared Jul 20, 2026
Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating...
K254231 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 203d
Cleared Jul 17, 2026
Tritanium® C Anterior Cervical Cage
K262061 · ODP
Stryker Spine
Orthopedic · 29d
Cleared Jul 17, 2026
AssureTech Quick Cup Tests
K261984 · NFT
Assure Tech., LLC
Toxicology · 35d