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
8305–8328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2023
Meta G UCLA Abutment
K232546 · NHA
Cowellmedi Co., Ltd.
Dental · 90d
Cleared Nov 21, 2023
Brainomix 360 Triage Stroke
K232496 · QAS
Brainomix Limited
Radiology · 96d
Cleared Nov 21, 2023
High Pressure Tubing
K232388 · DXT
Ningbo Dizegens Medical Science Co.,Ltd
General Hospital · 104d
Cleared Nov 21, 2023
Nu Skin RenuSpa iO
K232001 · NFO
Nse Products, Inc.
Neurology · 139d
Cleared Nov 21, 2023
PNK Total Knee System
K231975 · JWH
Tjc Life Co., Ltd.
Orthopedic · 141d
Cleared Nov 21, 2023
Mini-OSTEO Pedicle Fixation System
K231443 · NKB
Osteomed Ind?stria E Com?rcio DE...
Orthopedic · 187d
Cleared Nov 21, 2023
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
K230834 · DPS
Trismed Co., Ltd.
Cardiovascular · 239d
Cleared Nov 21, 2023
Endoscopy Irrigation Tubing
K230773 · OCX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 245d
Cleared Nov 21, 2023
Ultrasonic Scaler Tips
K230641 · ELC
Guilin Refine Medical Instrument Co.,...
Dental · 258d
Cleared Nov 21, 2023
SaviSafe Safety Device
K230287 · MEG
Suzhou Savicred Biotechnology Co., Ltd.
General Hospital · 292d
Cleared Nov 21, 2023
CranioXpand
K230211 · PBJ
KLS-Martin L.P.
Neurology · 299d
Cleared Nov 21, 2023
Digital ClarusScope System, Digital NeuroPEN System
K223615 · GWG
Clarus Medical, LLC
Neurology · 351d
Cleared Nov 21, 2023
Oxy2Pro
K222511 · CCK
Southmedic, Inc.
Anesthesiology · 459d
Cleared Nov 21, 2023
Absorbable Cranial Flap Fixation System
K221606 · GXR
Chendu Medart Medical Scientific Co.,...
Neurology · 537d
Cleared Nov 20, 2023
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable...
K233351 · GEI
Hg Innovations, Ltd.
General & Plastic Surgery · 52d
Cleared Nov 20, 2023
Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with...
K233346 · GEI
Hg Innovations, Ltd.
General & Plastic Surgery · 52d
Cleared Nov 20, 2023
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
K232575 · OHT
Shenzhen Jianchao Intelligent...
General & Plastic Surgery · 87d
Cleared Nov 20, 2023
Harmony
K232555 · NFJ
Topcon Healthcare Solutions
Ophthalmic · 89d
Cleared Nov 20, 2023
The SensiTox B. anthracis Toxin Test
K232545 · QUU
First Light Diagnostics, Inc.
Microbiology · 90d
Cleared Nov 20, 2023
ARIETTA x10
K231941 · IYN
Fujifilm Healthcare Americas Corporation
Radiology · 143d
Cleared Nov 20, 2023
Ziehm Vision RFD
K231692 · OWB
Ziehm Imaging GmbH
Radiology · 164d
Cleared Nov 20, 2023
TraumaCad Neo
K231498 · LLZ
Brainlab , Ltd.
Radiology · 180d
Cleared Nov 20, 2023
RIWOtrack Navigation System
K230700 · OLO
Fiagon GmbH
Orthopedic · 252d
Cleared Nov 20, 2023
Zilia Ocular FC (ZIL-10002)
K230627 · HKI
Zilia, Inc.
Ophthalmic · 259d