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
10825–10848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2023
BoneMRI v1.6
K230197 · QIH
Mriguidance B.V.
Radiology · 28d
Cleared Feb 22, 2023
Disposable Pre-calibrated Brain Biopsy Needle 2.0
K230201 · HAW
PAJUNK GmbH Medizintechnologie
Neurology · 28d
Cleared Feb 22, 2023
Swoop® Portable MR Imaging System™
K230208 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Feb 22, 2023
The Alma Soprano Titanium
K230371 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 9d
Cleared Feb 21, 2023
BOND MMR Antibody Panel
K213348 · PZJ
Leica Biosystems Newcastle, Ltd.
Pathology · 501d
Cleared Feb 21, 2023
Quantia IgE
K214068 · DGC
Biokit, S.A.
Immunology · 421d
Cleared Feb 21, 2023
Introducer Sheath Kits
K222184 · DYB
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 214d
Cleared Feb 21, 2023
NEONA 1.5T MRI System
K222259 · LNH
Time Medical Limited
Radiology · 208d
Cleared Feb 21, 2023
FreeStyle Libre 2 System, FreeStyle Libre 3 System
K223537 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Feb 21, 2023
Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
K223612 · KNW
Ranfac Corporation
General & Plastic Surgery · 78d
Cleared Feb 21, 2023
Verifine® Ease Lancing Device, Verifine® Lancing Device
K223643 · QRL
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 77d
Cleared Feb 18, 2023
Painless IPL System - KDT750
K220214 · ONF
Shanghai Omni Laser Skinology Co., Ltd.
General & Plastic Surgery · 388d
Cleared Feb 18, 2023
FloNavi Endoscopic Fluorescence Imaging System
K221861 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 236d
Cleared Feb 17, 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT...
K213755 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 444d
Cleared Feb 17, 2023
Infrared Thermometer TET-351
K220276 · FLL
Truly Instrument Limited
General Hospital · 382d
Cleared Feb 17, 2023
Doctor Tecar Plus, Doctor Tecar Smart
K221043 · PBX
Mectronic Medicale S.R.L.
General & Plastic Surgery · 315d
Cleared Feb 17, 2023
FlowSaver Blood Return System
K221483 · CAC
Inari Medical, Inc.
Cardiovascular · 270d
Cleared Feb 17, 2023
Equashield Closed System Transfer Device
K221513 · ONB
Equashield Medical , Ltd.
General Hospital · 268d
Cleared Feb 17, 2023
PROstep(TM) MIS 5mm Chamfer Screw System
K221645 · HWC
Wright Medical Technology
Orthopedic · 256d
Cleared Feb 17, 2023
EON
K222226 · PKT
Dominion Aesthetic Technologies, Inc.
General & Plastic Surgery · 207d
Cleared Feb 17, 2023
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
K222588 · FLL
Iweecare Co., Ltd.
General Hospital · 175d
Cleared Feb 17, 2023
troCarWash™ System
K222695 · OCX
Biotex, Inc.
General & Plastic Surgery · 164d
Cleared Feb 17, 2023
ULTRABUTTON QUAD Adjustable Fixation Device
K222971 · MBI
Smith & Nephew, Inc.
Orthopedic · 143d
Cleared Feb 17, 2023
DSPS-Prominent™ Masks
K222977 · IYE
Macromedics BV
Radiology · 142d