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
8857–8880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2023
B.Light Clear Evo and B.Light Restore Evo
K223919 · OHS
Bemer Int AG
General & Plastic Surgery · 268d
Cleared Sep 23, 2023
Osstem Implant System
K222778 · DZE
Osstem Implant Co., Ltd.
Dental · 374d
Cleared Sep 22, 2023
DX. Bond V Dental Bonding Adhesive
K232978 · KLE
Sino-Dentex Co., Ltd.
Dental · 1d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232594 · LJS
L&Z Us, Inc.
General Hospital · 28d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232571 · LJS
L&Z Us, Inc.
General Hospital · 29d
Cleared Sep 22, 2023
UroLift 2 ATC Advanced Tissue Control System
K232558 · PEW
Neotract, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 22, 2023
iLet® Dosing Decision Software
K232224 · QJI
Beta Bionics, Inc.
Chemistry · 57d
Cleared Sep 22, 2023
Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02,...
K232193 · ITI
Yurob Rehabilitation Medical Co., Ltd.
Physical Medicine · 59d
Cleared Sep 22, 2023
IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
K232183 · OHT
Shenzhen Koli Technology Co.,Ltd
General & Plastic Surgery · 60d
Cleared Sep 22, 2023
Annalise Enterprise CTB Triage Trauma
K231767 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 98d
Cleared Sep 22, 2023
FemaSeed Intratubal Insemination
K231730 · MQF
Femasys, Inc.
Obstetrics & Gynecology · 101d
Cleared Sep 22, 2023
TriALTIS Spine System
K231479 · NKB
Medos International SARL
Orthopedic · 123d
Cleared Sep 22, 2023
Single-Use Latex Sterile Surgical Gloves (SG100)
K231446 · KGO
Fitone Latex Products Co., Ltd....
General Hospital · 127d
Cleared Sep 22, 2023
Annalise Enterprise CTB Triage Trauma
K231384 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 133d
Cleared Sep 22, 2023
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
K231239 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 147d
Cleared Sep 22, 2023
qXR-CTR
K231149 · QIH
Qure.Ai Technologies
Radiology · 154d
Cleared Sep 22, 2023
T-SHAPE 2
K231092 · NUV
B&M S.R.L. Marketing Nel Benessere
General & Plastic Surgery · 157d
Cleared Sep 22, 2023
MicroMatrix® Flex
K230980 · KGN
Acell, Inc.
General & Plastic Surgery · 170d
Cleared Sep 22, 2023
VISULAS yag
K230350 · HQF
Carl Zeiss Meditec, Inc.
Ophthalmic · 225d
Cleared Sep 22, 2023
Para-Fix External Fixation System
K230067 · LXT
New Paradigm Biomedical
Orthopedic · 256d
Cleared Sep 22, 2023
Access CEA
K223921 · DHX
Beckman Coulter, Inc.
Immunology · 267d
Cleared Sep 22, 2023
Jazz
K223659 · LLZ
Ai Medical AG
Radiology · 290d
Cleared Sep 22, 2023
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817 · MRG
Immunostics Inc.,
Chemistry · 457d
Cleared Sep 22, 2023
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle...
K220179 · EFB
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 609d