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: Cleared only ×
175,230 results
10897–10920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2023
Air Compression Leg Massager (model: EMK-701)
K222991 · IRP
Xiamen Emoka Health Science &...
Physical Medicine · 168d
Cleared Mar 15, 2023
Tegamen Nitrile Examination Gloves
K223102 · LZA
M/S Tegamen Safety Products Private...
General Hospital · 166d
Cleared Mar 15, 2023
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low...
K223375 · LZA
Kossan International Sdn Bhd3
General Hospital · 131d
Cleared Mar 15, 2023
iExaminer System with Panoptic Plus
K223381 · HKI
Welch Allyn, Inc.
Ophthalmic · 128d
Cleared Mar 15, 2023
ECHELON LINEAR™ 60 mm Cutter (GLC60)
K223760 · GDW
Ethicon Endo-Surgery
General & Plastic Surgery · 90d
Cleared Mar 15, 2023
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
K230124 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 57d
Cleared Mar 14, 2023
HeartBuds Electronic Stethoscope
K212906 · DQD
Heartbuds, LLC
Cardiovascular · 547d
Cleared Mar 14, 2023
JETT PLASMA Medical II
K213247 · QVJ
Compex, Spol, S.R.O.
General & Plastic Surgery · 530d
Cleared Mar 14, 2023
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
K223137 · QUH
Hearx SA (Pty) , Ltd.
Ear, Nose, Throat · 161d
Cleared Mar 14, 2023
RT Elements (4.0)
K223279 · MUJ
Brainlab AG
Radiology · 141d
Cleared Mar 14, 2023
Leg and Foot Air Wave Pressure Therapy Device
K223464 · IRP
Zhangzhou Easepal Innovation CO , Ltd.
Physical Medicine · 117d
Cleared Mar 14, 2023
RevCore™ Thrombectomy Catheter.
K223609 · QEW
Inari Medical, Inc.
Cardiovascular · 102d
Cleared Mar 14, 2023
Cervical Plate System
K223753 · KWQ
Double Medical Technology, Inc.
Orthopedic · 90d
Cleared Mar 14, 2023
SofWave System
K230019 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 70d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Mar 13, 2023
Surgical Face Mask
K221352 · FXX
Wuhan Huashida Protective Products...
General Hospital · 307d
Cleared Mar 13, 2023
Aarhus Applicator Set
K222775 · JAQ
Varian Medical Systems, Inc.
Radiology · 180d
Cleared Mar 13, 2023
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
K222954 · LPL
Innova Vision, Inc.
Ophthalmic · 167d
Cleared Mar 13, 2023
Omnia Medical Coupler-C Anterior Cervical Plate
K223321 · KWQ
Omnia Medical, LLC
Orthopedic · 133d
Cleared Mar 13, 2023
Remi Robotic Navigation System
K223350 · OLO
Fusion Robotics, LLC
Orthopedic · 131d
Cleared Mar 12, 2023
High Protection Surgical Gown
K222456 · FYA
3A Medical Products Co., Ltd.
General Hospital · 209d
Cleared Mar 10, 2023
Avoset Infusion Pump System
K213744 · FRN
Eitan Medical , Ltd.
General Hospital · 466d
Cleared Mar 10, 2023
Aristotle 14 Guidewire
K220398 · MOF
Scientia Vascular, LLC
Neurology · 392d
Cleared Mar 10, 2023
CloudTMS for OCD
K221129 · QCI
Teleemg, LLC
Neurology · 326d