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
8185–8208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2023
Intense Pulse Light Therapeutic Apparatus
K232932 · OHT
Shenzhen Greatro Electronic...
General & Plastic Surgery · 75d
Cleared Dec 04, 2023
Tyber Medical Distal Radius Plating System
K232693 · HRS
Tyber Medical, LLC
Orthopedic · 90d
Cleared Dec 04, 2023
Medical Disposable Sterile Needle Electrode
K232581 · GXZ
Suzhou Haishen Medical Device...
Neurology · 101d
Cleared Dec 04, 2023
Monarch Blood Collection Set
K232308 · JKA
The Monarch Company
General Hospital · 124d
Cleared Dec 04, 2023
Maxtec MaxBlend2+p
K231895 · BZR
Maxtec, LLC
Anesthesiology · 159d
Cleared Dec 04, 2023
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
K230724 · JDR
Novastep
Orthopedic · 263d
Cleared Dec 04, 2023
Access hsTnI
K230648 · MMI
Beckman Coulter, Inc.
Chemistry · 270d
Cleared Dec 04, 2023
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
K223783 · QWR
Roche Molecular Systems, Inc.
Microbiology · 353d
Cleared Dec 04, 2023
RESPONDER Polysaccharide Hemostat
K220525 · QSY
Starch Medical, Inc.
General & Plastic Surgery · 649d
Cleared Dec 02, 2023
Cosine-10TM Diagnostic Catheter
K233397 · DRF
Medtronic, Inc.
Cardiovascular · 60d
Cleared Dec 01, 2023
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free...
K233529 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 29d
Cleared Dec 01, 2023
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
K233301 · GEX
Lumenis Be, Ltd.
General & Plastic Surgery · 63d
Cleared Dec 01, 2023
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502,...
K233159 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 65d
Cleared Dec 01, 2023
CATHTONG III Tapered PICC Catheter
K233149 · LJS
L&Z Us, Inc.
General Hospital · 65d
Cleared Dec 01, 2023
Syngo Carbon Clinicals
K232856 · QIH
Siemens Healthcare GmbH
Radiology · 77d
Cleared Dec 01, 2023
Comatryx OTC
K232758 · KGN
Strukmyer Medical, LLC
General & Plastic Surgery · 84d
Cleared Dec 01, 2023
Intense pulsed light therapy device
K232708 · ONF
Hebei Zhemai Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 01, 2023
Dental Glass Ceramics Blocks
K232438 · EIH
Aibodent Biotechnology Co., Ltd.
Dental · 109d
Cleared Dec 01, 2023
Single Platform SP1 Implant System
K232418 · DZE
Southern Implants (Pty), Ltd.
Dental · 112d
Cleared Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
K232249 · ODC
Pentax of America, Inc.
Gastroenterology & Urology · 126d
Cleared Dec 01, 2023
Woo More Play Coconut Love Oil
K232093 · NUC
Woo Essentials, Inc.
Obstetrics & Gynecology · 141d
Cleared Dec 01, 2023
AlignerFlow LC
K231817 · DYH
Voco GmbH
Dental · 163d
Cleared Dec 01, 2023
TRUENESS™ AIR Blood Glucose Monitoring System
K231476 · NBW
Sinocare, Inc.
Chemistry · 193d
Cleared Dec 01, 2023
OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber®...
K231272 · HTY
OSSIO , Ltd.
Orthopedic · 213d