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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14281–14304 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2021
NObreath®
K203695 · MXA
Bedfont Scientific, Ltd.
Chemistry · 364d
Cleared Dec 17, 2021
Donagamex Blue Performance Protective Gown
K203821 · QPC
Dong Nai Garment Corporation (Donagamex)
General Hospital · 353d
Cleared Dec 17, 2021
MED RF 4000
K210077 · ONQ
F Care Systems USA, LLC
General & Plastic Surgery · 339d
Cleared Dec 17, 2021
Topwide Surgical Face Mask
K210102 · FXX
Topwide (Hubei) Medical Products...
General Hospital · 337d
Cleared Dec 17, 2021
Revitive Medic Coach (Model Number 5575AQ)
K210825 · NGX
Actegy , Ltd.
Physical Medicine · 273d
Cleared Dec 17, 2021
PDO Max Suture with Dual Needle
K210871 · NEW
Pdo Max, Inc.
General & Plastic Surgery · 268d
Cleared Dec 17, 2021
Sterile Syringe for Single Use
K210914 · FMF
Jiangsu Suyun Medical Material Co., Ltd.
General Hospital · 263d
Cleared Dec 17, 2021
Libby IAAA v1.0
K210931 · LLZ
Dyad Medical, Inc.
Cardiovascular · 263d
Cleared Dec 17, 2021
Single Use Electrosurgical Knife with Fluid Pump System
K211172 · GEI
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 242d
Cleared Dec 17, 2021
Hycare Med+ Nitrile Examination Gloves
K211209 · LZA
Hycare International Co., Ltd.
General Hospital · 238d
Cleared Dec 17, 2021
Cordless Prophy System, Model: i-Polish
K211531 · EKX
Guilin Woodpecker Medical Instrument...
Dental · 214d
Cleared Dec 17, 2021
Surgical Face Mask
K212059 · FXX
Zhongshan Saifute Labor Protective...
General Hospital · 169d
Cleared Dec 17, 2021
EMBOGUARD Balloon Guide Catheter
K212340 · QJP
Neuravi Limited
Neurology · 142d
Cleared Dec 17, 2021
Avenger Radial Head System
K212872 · KWI
In2bones USA, LLC
Orthopedic · 99d
Cleared Dec 17, 2021
Physica system
K213381 · JWH
Lima Corporate S.P.A.
Orthopedic · 65d
Cleared Dec 17, 2021
InkSpace Imaging Pediatric Body Array
K213397 · MOS
Inkspace Imaging, Inc.
Radiology · 60d
Cleared Dec 17, 2021
RF Vapor System
K213627 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 17, 2021
Arthrex Knotless Mini TightRopes
K213644 · HTN
Arthrex, Inc.
Orthopedic · 29d
Cleared Dec 17, 2021
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex...
K213715 · JAK
Ge Medical Systems, LLC
Radiology · 23d
Cleared Dec 16, 2021
Activmotion S DTO
K202803 · HRS
Newclip Technics
Orthopedic · 449d
Cleared Dec 16, 2021
Voyant Fine Fusion Device (EB230)
K202818 · GEI
Applied Medical
General & Plastic Surgery · 448d
Cleared Dec 16, 2021
Surgical Gown, Model: surgical gown-hp-3
K210355 · FYA
Weihai Dishang Medical Technology...
General Hospital · 311d
Cleared Dec 16, 2021
Profound Matrix
K211217 · GEI
Candela Corporation
General & Plastic Surgery · 237d
Cleared Dec 16, 2021
Theia NPWT Foam Wound Dressing Kit
K211277 · OMP
Clear Choice Therapeutics, Inc.
General & Plastic Surgery · 233d