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
7345–7368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2024
X-Clever (ASHK100G)
K233599 · LLZ
Lg Electronics.Inc
Radiology · 130d
Cleared Mar 16, 2024
Meriglu Topical Skin Adhesive
K230981 · MPN
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 346d
Cleared Mar 15, 2024
FORMA Composite (Shade A3D)
K240694 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Mar 15, 2024
Vital™ Spinal Fixation System
K240539 · NKB
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Orthopedic · 18d
Cleared Mar 15, 2024
STARband 3D
K240466 · OAN
Orthomerica Products, Inc.
Neurology · 28d
Cleared Mar 15, 2024
RESPONDER® Polysaccharide Hemostat
K240454 · QSY
Starch Medical, Inc.
General & Plastic Surgery · 29d
Cleared Mar 15, 2024
MILAGRO Interference Screw
K240441 · MAI
Depuy Mitek
Orthopedic · 30d
Cleared Mar 15, 2024
Otoport Pro
K240430 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 30d
Cleared Mar 15, 2024
Aventus Thrombectomy System (IM-2001/IM-0002)
K240117 · QEW
Inquis Medical
Cardiovascular · 59d
Cleared Mar 15, 2024
Light Cure Composite
K240112 · EBF
Sincera Technology (Changchun) Co., Ltd.
Dental · 59d
Cleared Mar 15, 2024
APRO 55 Catheter
K234115 · DQY
Alembic, LLC
Neurology · 79d
Cleared Mar 15, 2024
PICOANDY (Q-Switched Nd:YAG Laser)
K234104 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 80d
Cleared Mar 15, 2024
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
K233986 · LON
Becton, Dickinson and Company
Microbiology · 88d
Cleared Mar 15, 2024
ivWatch® Model 400
K233881 · PMS
Ivwatch, LLC
General Hospital · 98d
Cleared Mar 15, 2024
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack...
K233814 · FRC
3M Company
General Hospital · 106d
Cleared Mar 15, 2024
Wrist Blood Pressure Monitor (222)
K233799 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 107d
Cleared Mar 15, 2024
CIARTIC Move (VB10)
K233748 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 114d
Cleared Mar 15, 2024
Concha Sol Hearing Aids (CL-1001)
K233747 · QUH
Concha Labs
Ear, Nose, Throat · 114d
Cleared Mar 15, 2024
CINA-ASPECTS
K233342 · POK
Avicenna.Ai
Radiology · 168d
Cleared Mar 15, 2024
Intensity Pulsed Light Therapy System
K233307 · ONF
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 168d
Cleared Mar 15, 2024
Endorail
K232327 · ODC
Endostart S.R.L.
Gastroenterology & Urology · 225d
Cleared Mar 15, 2024
Nouvo Safety Set
K232234 · FOZ
Poly Medicure Limited
General Hospital · 232d
Cleared Mar 15, 2024
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
K231856 · QNQ
Medexel Co.,Ltd
General Hospital · 266d
Cleared Mar 15, 2024
Xprecia Prime Coagulation System
K230802 · GJS
Universal Biosensors Pty, Ltd.
Hematology · 358d