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
12145–12168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 20, 2022
V-Patch Cardiac Monitor
K222842 · DXH
Shandong Corecare Technology Limited
Cardiovascular · 30d
Cleared Oct 20, 2022
Mercu 1717V
K222886 · MQB
Iray Technology Taicang , Ltd.
Radiology · 27d
Cleared Oct 19, 2022
Proximerge 2 Dental Implant System
K211409 · DZE
Quadric Biomed, LLC
Dental · 531d
Cleared Oct 19, 2022
Infinity Pro, Logic, Quality, Sprint
K213742 · EIA
Olsen Ind?stria E Com?rcio S.A.
Dental · 324d
Cleared Oct 19, 2022
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
K220992 · LYZ
Ever Global (Vietnam) Enterprise...
General Hospital · 198d
Cleared Oct 19, 2022
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
K221029 · PSQ
Synovis Life Technologies, Inc.
Cardiovascular · 195d
Cleared Oct 19, 2022
Vascu-Guard Vascular Repair Patch
K221032 · PSQ
Synovis Life Technologies, Inc.
Cardiovascular · 195d
Cleared Oct 19, 2022
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System,...
K221728 · KWQ
Stryker Corporation
Orthopedic · 127d
Cleared Oct 19, 2022
STERN FIX Sternal Stabilization System
K221795 · JDQ
Neos Surgery S.L
Orthopedic · 120d
Cleared Oct 19, 2022
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K222643 · PBY
Sirius Medical Systems B.V.
General & Plastic Surgery · 48d
Cleared Oct 19, 2022
SOMAVAC 100 Sustained Vacuum System
K222856 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 28d
Cleared Oct 19, 2022
RADIANCE ULTRA 32 4K ZEROWIRE DUO
K222890 · GCJ
Nds Surgical Imaging, LLC
General & Plastic Surgery · 26d
Cleared Oct 18, 2022
Nova Primary Glucose Analyzer System
K203549 · CGA
Nova Biomedical Corporation
Chemistry · 683d