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
7897–7920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2024
Pursuant Health Kiosk (G1.D5)
K230996 · DXN
Pursuant Health
Cardiovascular · 272d
Cleared Jan 04, 2024
Zimed Distal Medial Tibial Plate and Screw System
K230507 · HWC
Zimed Medikal
Orthopedic · 314d
Cleared Jan 04, 2024
Pulse Oximeter(Model OHT60,OXH78)
K230277 · DQA
Cofoe Medical Technology Co., Ltd.
Anesthesiology · 337d
Cleared Jan 04, 2024
Dayspring
K223228 · JOW
Koya Medical, Inc.
Cardiovascular · 443d
Cleared Jan 04, 2024
LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial...
K221110 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 629d
Cleared Jan 03, 2024
Portable Dental X-Ray (AXR60 S)
K233395 · EHD
Alliage S/A Industrias M?dico...
Radiology · 92d
Cleared Jan 03, 2024
Horos MD™
K232589 · LLZ
Icat Solutions, Ltd.
Radiology · 131d
Cleared Jan 03, 2024
REMI AI Discrete Detection Module
K231779 · OMB
Epitel, Inc.
Neurology · 201d
Cleared Jan 03, 2024
ResQ Administration Set
K231707 · FPA
Q For Plastic Industries
General Hospital · 205d
Cleared Jan 03, 2024
Carecube Negative Pressure Isolation Chamber
K231256 · LGM
Carecubes, Inc.
General Hospital · 247d
Cleared Jan 03, 2024
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA...
K223397 · LPL
Hoya Lamphun , Ltd.
Ophthalmic · 421d
Cleared Jan 02, 2024
MOSAIC 3D (Surgical Laser)
K233550 · ONG
Lutronic Aesthetic
General & Plastic Surgery · 60d
Cleared Dec 29, 2023
Precision1
K233856 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 24d
Cleared Dec 29, 2023
ACL TOP 970 CL
K233790 · JPA
Instrumentation Laboratory
Hematology · 31d
Cleared Dec 29, 2023
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
K233362 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 29, 2023
NQ TMS for MDD (NQv1-MU-01)
K232688 · OBP
Neuroqore, Inc.
Neurology · 119d
Cleared Dec 29, 2023
Bladder Scanner
K230986 · IYO
Avantsonic Technology Co., Ltd.
Radiology · 267d
Cleared Dec 29, 2023
URIS Smart Path Implant System & Prosthetic
K230438 · DZE
Truabutment, Inc.
Dental · 311d
Cleared Dec 29, 2023
UniFit Dental Implant System
K223714 · DZE
Adin Dental Implant Systems , Ltd.
Dental · 382d
Cleared Dec 28, 2023
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and...
K233405 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 84d
Cleared Dec 28, 2023
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark...
K231055 · EHD
De G?tzen S.R.L.
Radiology · 259d
Cleared Dec 28, 2023
EvoWalk 1.0 System
K230997 · GZI
Evolution Devices, Inc.
Neurology · 265d
Cleared Dec 28, 2023
Planmeca Viso
K230985 · OAS
Planmeca Oy
Radiology · 266d
Cleared Dec 28, 2023
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
K230891 · MBI
Healthium Medtech Limited
Orthopedic · 272d