FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10273–10296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2023
Model 9160 VitaloQUB
K223818 · JEH
Vitalograph (Ireland) , Ltd.
Anesthesiology · 155d
Cleared May 25, 2023
Genesis ACTIVE Implant System
K223814 · DZE
Keystone Dental, Inc.
Dental · 156d
Cleared May 25, 2023
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care...
K223491 · QBS
Ge Medical Systems, LLC
Radiology · 185d
Cleared May 25, 2023
Dental Desensitizer
K222891 · LBH
Guangzhou Beogene Biotech Co., Ltd.
Dental · 244d
Cleared May 25, 2023
Nipro SafeTouch Needle
K222852 · FMI
Nipro Medical Corporation
General Hospital · 246d
Cleared May 25, 2023
KLS Martin LINOS Wrist System
K222624 · HRS
KLS-Martin L.P.
Orthopedic · 267d
Cleared May 25, 2023
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
K222311 · FLL
Circa Scientific, Inc.
Cardiovascular · 297d
Cleared May 25, 2023
Advanced LumFix Spinal Fixation System
K222229 · NKB
CG Bio Co., Ltd.
Orthopedic · 304d
Cleared May 25, 2023
Armis VeriCyn Wound Wash
K220759 · FQH
Armis Biopharma, Inc.
General & Plastic Surgery · 436d
Cleared May 25, 2023
ThermoTK
K213256 · PBX
Zimmer Medizinsysteme GmbH
General & Plastic Surgery · 602d
Cleared May 24, 2023
s-Clean Link Abutment Narrow
K230523 · NHA
Dentis Co., Ltd.
Dental · 86d
Cleared May 24, 2023
General Cutting Straight
K230106 · EGS
Nakanishi, Inc.
Dental · 131d
Cleared May 24, 2023
SIMDA Abutment
K223663 · NHA
Simda Co., Ltd.
Dental · 168d
Cleared May 24, 2023
Reprieve by RegenesisTM
K223620 · IMJ
Regenesis Biomedical, Inc.
Physical Medicine · 170d
Cleared May 24, 2023
coactiv+™ Antimicrobial Wound Gel
K223259 · FRO
Kane Biotech, Inc.
General & Plastic Surgery · 212d
Cleared May 24, 2023
Avatar Medical Software V1
K222035 · LLZ
Avatar Medical
Radiology · 317d
Cleared May 24, 2023
Oxymag - Transport and Emergency Ventilator
K221634 · BTL
Magnamed Tecnologia Medica S/A
Anesthesiology · 352d
Cleared May 23, 2023
ACTERA™ hip system
K231178 · MEH
Conformis, Inc.
Orthopedic · 27d
Cleared May 23, 2023
ROSA Hip System
K231162 · LLZ
Orthosoft Inc. (d/b/a) Zimmer CAS
Radiology · 29d
Cleared May 23, 2023
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
K230874 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 54d
Cleared May 23, 2023
ADAS 3D
K230803 · LLZ
Adas3D Medical S.L.
Radiology · 61d
Cleared May 23, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
K230564 · LZA
Central Medicare Sdn Bhd
General Hospital · 83d
Cleared May 23, 2023
uMR Omega
K230152 · LNH
Shanghai United Imaging Healthcare...
Radiology · 124d
Cleared May 23, 2023
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
K230134 · OAP
Hubei Yjt Technology Co.,Ltd
General & Plastic Surgery · 126d