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
10153–10176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2023
LED Facial Mask
K230351 · OHS
Shenzhen Sungpo Hi-Tech Electronic...
General & Plastic Surgery · 85d
Cleared May 05, 2023
Lexa MINI (RIS-303, RIS-305)
K223858 · FLE
W&H Sterilization S.R.L.
General Hospital · 133d
Cleared May 05, 2023
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model...
K222926 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 221d
Cleared May 05, 2023
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
K221768 · HQD
Paragon Vision Sciences, Inc.
Ophthalmic · 322d
Cleared May 05, 2023
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA...
K220781 · EZN
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 414d
Cleared May 05, 2023
ELEC Master, ELEC Master Dual
K202963 · EIA
Mgnewton , Ltd.
Dental · 947d
Cleared May 04, 2023
Alinity i STAT High Sensitivity Troponin-I
K230994 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 27d
Cleared May 04, 2023
DLP™ Silicone Coronary Artery Ostial Cannulae
K230960 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 04, 2023
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System,...
K230653 · JWH
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared May 04, 2023
Hubly Electric Drill (H100)
K230619 · HBE
Hubly, Inc.
Neurology · 59d
Cleared May 04, 2023
SOZO Pro
K230531 · QJB
ImpediMed Limited
Gastroenterology & Urology · 66d
Cleared May 04, 2023
SOZO Pro
K230530 · OBH
ImpediMed Limited
Gastroenterology & Urology · 66d
Cleared May 04, 2023
Lucas Plus
K230340 · GEX
Amt Engineering Co., Ltd.
General & Plastic Surgery · 86d
Cleared May 04, 2023
Orchid Safety Release Valve
K230266 · QOI
Linear Health Sciences, LLC
General Hospital · 93d
Cleared May 04, 2023
Auto Segmentation
K230082 · QKB
Ge Medical Systems, LLC
Radiology · 113d
Cleared May 04, 2023
Agnes
K223805 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 136d
Cleared May 04, 2023
Lumify Diagnostic Ultrasound System
K223771 · IYN
Philips Ultrasound
Radiology · 139d
Cleared May 04, 2023
SimPro™ Now, GentleCath™ Hydrophilic
K223756 · EZD
Dentsply Sirona
Gastroenterology & Urology · 140d
Cleared May 04, 2023
ProLift Micro Expandable Spacer System
K223430 · MAX
Life Spine, Inc.
Orthopedic · 171d
Cleared May 04, 2023
Ceramic Brackets Orthometric
K222847 · NJM
Orthometric - Industria E Comercio DE...
Dental · 225d
Cleared May 04, 2023
swiftPro System
K222388 · NEY
Emblation , Ltd.
General & Plastic Surgery · 269d
Cleared May 04, 2023
OLYMPIC Deformity Band System
K222097 · OWI
Astura Medical
Orthopedic · 290d
Cleared May 04, 2023
Finger Pulse Oximeter, Model: X1906P
K221798 · DQA
Shenzhen Changkun Technology Co., Ltd.
Anesthesiology · 317d
Cleared May 04, 2023
Sol-Guard Auto-disable Syringe
K220713 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 419d