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
5545–5568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 2024
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
K231997 · ILY
Cure Point Therapeutics, Inc.
General & Plastic Surgery · 468d
Cleared Oct 12, 2024
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
K242812 · LZA
Nb Medical Company Limited
General Hospital · 24d
Cleared Oct 11, 2024
Legend® Acetabular Shell
K242833 · LPH
Ortho Development Corp.
Orthopedic · 22d
Cleared Oct 11, 2024
Hood (DH-083ST)
K242779 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Oct 11, 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · MUH
Qpix Solutions, Inc.
Radiology · 28d
Cleared Oct 11, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K242742 · ODC
STERIS Corporation
Gastroenterology & Urology · 30d
Cleared Oct 11, 2024
Mobility Scooter (N3473)
K242387 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 60d
Cleared Oct 11, 2024
Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)
K242133 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 81d
Cleared Oct 11, 2024
Access Toxo IgM II
K242095 · LGD
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Oct 11, 2024
Accure Laser System
K242035 · GEX
Accure Acne, Inc.
General & Plastic Surgery · 91d
Cleared Oct 11, 2024
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
K241971 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Oct 11, 2024
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
K241857 · OHS
Dongguan Boyuan Intelligent...
General & Plastic Surgery · 106d
Cleared Oct 11, 2024
syngo Application Software
K241569 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Oct 11, 2024
SPECTRALIS with Flex Module
K241163 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 168d
Cleared Oct 11, 2024
Progressive Orthodontics App
K241153 · PNN
Progressive Aligners, Inc.
Dental · 168d
Cleared Oct 11, 2024
Reprocessed DECANAV™ Electrophysiology Catheter
K240826 · NLH
Sterilmed, Inc.
Cardiovascular · 199d
Cleared Oct 11, 2024
PPH Saliva Collection Kit
K240797 · QBD
Permantis Public Health
Microbiology · 203d
Cleared Oct 11, 2024
Spark™ Clear Aligner System
K240501 · NXC
Ormco Corporation
Dental · 233d
Cleared Oct 11, 2024
ARTAIRA Arterial Compression Device (AACD01)
K240499 · JOW
Airos Medical, Inc.
Cardiovascular · 234d
Cleared Oct 11, 2024
PBM Hair Therapy Cap
K240472 · OAP
Dongguan Tutamen Metalwork Co., Ltd.
General & Plastic Surgery · 234d
Cleared Oct 11, 2024
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy...
K240242 · LCX
Anhui Deepblue Medical Technology...
Chemistry · 255d
Cleared Oct 11, 2024
JDZygoma dental implants
K240143 · DZE
Jdentalcare Srl
Dental · 267d
Cleared Oct 11, 2024
Belun Ring BLR-200 (BLR-200)
K234110 · DQA
Belun Technology Company Limited
Anesthesiology · 289d
Cleared Oct 11, 2024
Monotime and Optime R
K233265 · GAM
Peters Surgical
General & Plastic Surgery · 378d