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
11857–11880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 2022
Flex-MI
K221958 · IPF
Emsi, Inc.
Physical Medicine · 108d
Cleared Oct 21, 2022
Electronic Pulse Stimulator
K221992 · NUH
Beijing Choice Electronic Technology...
Neurology · 107d
Cleared Oct 21, 2022
Safety Blood Collection Needle (Without Needle Holder)
K222141 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 93d
Cleared Oct 21, 2022
Collagen P.I.N. (Percutaneous Induction Needling)
K222199 · QAI
Induction Therapies, LLC
General & Plastic Surgery · 91d
Cleared Oct 21, 2022
Biological Feedback and Stimulation System
K222201 · IPF
Medlander Medical Technology, Inc.
Physical Medicine · 88d
Cleared Oct 21, 2022
IPD Dental Implant Abutments
K222215 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 88d
Cleared Oct 21, 2022
HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer,...
K222270 · ODP
Globus Medical, Inc.
Orthopedic · 84d
Cleared Oct 21, 2022
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
K222349 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 79d
Cleared Oct 21, 2022
UHR Bipolar Implants, Restoration GAP II Implants
K222632 · KWL
Howmedica Osteonics Corp., Dba...
Orthopedic · 51d
Cleared Oct 21, 2022
Viz LVO ContaCT
K223042 · QAS
Viz. Ai, Inc.
Radiology · 22d
Cleared Oct 20, 2022
BTI Interna Dental Implant System UnicCa - Prosthetic Components
K213106 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 391d
Cleared Oct 20, 2022
AccuSert Needle Inserter
K213429 · KZH
Emed Technologies Corporation
General Hospital · 364d
Cleared Oct 20, 2022
Houdini Cross Support Catheter
K213466 · DQY
Cruzar Medsystems, Inc.
Cardiovascular · 357d
Cleared Oct 20, 2022
eWave Monitor
K214073 · DSH
Wearlinq, Inc.
Cardiovascular · 297d
Cleared Oct 20, 2022
eClinic Stethopod
K220099 · DQD
Homediagnostic, LLC
Cardiovascular · 281d
Cleared Oct 20, 2022
PADnet Xpress
K220527 · JOM
Collaborative Care Diagnostics, LLC,...
Cardiovascular · 238d
Cleared Oct 20, 2022
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global...
K220870 · QMV
Biofire Defense, LLC
Microbiology · 209d
Cleared Oct 20, 2022
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447),...
K221740 · GCJ
Smith and Nephew, Inc.
General & Plastic Surgery · 127d
Cleared Oct 20, 2022
Tyber Medical Staple Fixation System (various)
K221947 · JDR
Tyber Medical, LLC
Orthopedic · 107d
Cleared Oct 20, 2022
Disposable Surgical Gown (G4003)
K221977 · FYA
Xiantao Topmed Nonwoven Protective...
General Hospital · 107d
Cleared Oct 20, 2022
AI-Rad Companion (Musculoskeletal)
K222361 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Oct 20, 2022
Evo® sEEG System
K222404 · GZL
Neuroone Medical Technologies Corp.
Neurology · 72d
Cleared Oct 20, 2022
Electric nasal aspirator
K222547 · BTA
Shenzhen Xinlianfeng Technology Co.,Ltd
Ear, Nose, Throat · 58d
Cleared Oct 20, 2022
da Vinci Firefly Imaging System
K222827 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 31d