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
11641–11664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2022
Cardio10
K220535 · DPS
Bionet Co., Ltd.
Cardiovascular · 264d
Cleared Nov 15, 2022
ALPHALOK Plating System
K221558 · HRS
Vilex, LLC
Orthopedic · 168d
Cleared Nov 15, 2022
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722 · CAC
Haemonetics Corporation
Cardiovascular · 154d
Cleared Nov 15, 2022
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
K221744 · GAM
Ethicon, Inc.
General & Plastic Surgery · 152d
Cleared Nov 15, 2022
Disposable Sterile Lancet
K222055 · FMK
Tianjin Rilifine Medical Device Co.,...
General & Plastic Surgery · 126d
Cleared Nov 15, 2022
Bloomi Delight Oil-Based Personal Lubricant
K222175 · NUC
The Bloomi Inc..
Obstetrics & Gynecology · 117d
Cleared Nov 15, 2022
Gamma4 System
K222309 · HSB
Stryker GmbH
Orthopedic · 106d
Cleared Nov 15, 2022
Everyway Analog OTC TENS
K222488 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Nov 15, 2022
Treace Medical Concepts (TMC) Hammertoe Fixation System
K222564 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 83d
Cleared Nov 15, 2022
Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS ,...
K222915 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 50d
Cleared Nov 15, 2022
2.1 x 255mm Drill, 22mm Stop
K223199 · HBE
Biomet Microfixation
Neurology · 33d
Cleared Nov 14, 2022
Smith & Nephew Intramedullary Nail Systems
K210980 · HSB
Smith & Nephew, Inc.
Orthopedic · 592d
Cleared Nov 14, 2022
Disposable hemoclip
K213217 · PKL
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 411d
Cleared Nov 14, 2022
PosiSep X BAM Hemostat Dressing/Intranasal Splint
K220326 · EMX
Hemostasis, LLC
Ear, Nose, Throat · 283d
Cleared Nov 14, 2022
Hexanium ACIF
K221578 · OVE
Spinevision, S.A.S.
Orthopedic · 166d
Cleared Nov 14, 2022
Multiflex Steerable Sheath
K221655 · DYB
Vizaramed, Inc.
Cardiovascular · 160d
Cleared Nov 14, 2022
Syngo Dynamics (Version VA40F)
K222428 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 95d
Cleared Nov 14, 2022
Standard Surgical Gown (AAMI Level 2)
K222480 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 89d
Cleared Nov 14, 2022
HBL Blade Assembly
K222490 · HRX
Hand Biomechanics Lab, Inc.
Orthopedic · 89d
Cleared Nov 14, 2022
Zirconia Block
K222520 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 87d
Cleared Nov 14, 2022
Surgical Face Mask
K222529 · FXX
Xiantao Rayxin Medical Products Co.,...
General Hospital · 84d
Cleared Nov 14, 2022
uPMR 790
K222540 · OUO
Shanghai United Imaging Healthcare...
Radiology · 84d
Cleared Nov 14, 2022
High Fluid-Resistant Surgical and Procedure Mask
K222749 · FXX
America?S Supply Chains
General Hospital · 63d
Cleared Nov 12, 2022
Nitrile Examination Gloves
K213981 · LZA
Emerald Glove Manufacturing Sdn Bhd
General Hospital · 327d