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
4969–4992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2025
System 9 Sterile Battery Container
K242834 · KCT
Stryker Instruments
General Hospital · 119d
Cleared Jan 16, 2025
Pearl Clear Aligner
K242715 · NXC
Pearl Digital, Inc.
Dental · 128d
Cleared Jan 16, 2025
Second Opinion CC
K242522 · MYN
Pearl, Inc.
Radiology · 146d
Cleared Jan 16, 2025
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10,...
K242416 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 154d
Cleared Jan 16, 2025
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
K241736 · FRN
Deka Research and Development Corp.
General Hospital · 213d
Cleared Jan 16, 2025
CloudHRV™ System (100-01-001)
K241217 · DPS
Inmedix, Inc.
Cardiovascular · 260d
Cleared Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
K241176 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
Cleared Jan 16, 2025
VIVIX-M
K241113 · MUE
Vieworks Co., Ltd.
Radiology · 269d
Cleared Jan 16, 2025
cobas® liat CT/NG/MG nucleic acid test
K240197 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d
Cleared Jan 16, 2025
Pepper EMS Training System
K233770 · NGX
Pepper Interactive, Inc.
Physical Medicine · 419d
Cleared Jan 15, 2025
EffortMed Spinal Fixation System
K243946 · NKB
Effortmed, LLC
Orthopedic · 26d
Cleared Jan 15, 2025
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · PZX
AtriCure, Inc.
Cardiovascular · 30d
Cleared Jan 15, 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K243858 · JPA
Haemonetics Corporation
Hematology · 30d
Cleared Jan 15, 2025
FaStep Early Pregnancy Rapid Test Strip
K243573 · LCX
Assure Tech., LLC
Chemistry · 57d
Cleared Jan 15, 2025
TriMed Wrist Fixation System (Volar Bearing Plates)
K243569 · HRS
TriMed, Inc.
Orthopedic · 58d
Cleared Jan 15, 2025
Ziehm Vision RFD
K243328 · OWB
Ziehm Imaging GmbH
Radiology · 83d
Cleared Jan 15, 2025
RELiZORB (100300/ 100301)
K243284 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 15, 2025
Cardiac Guidance
K243065 · QJU
Caption Health, Inc.
Radiology · 110d
Cleared Jan 15, 2025
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with...
K242936 · LZA
Sunray Medical Products, Inc.
General Hospital · 112d
Cleared Jan 15, 2025
Respiration Data Management Software (PAP Link PC)
K242935 · BZD
BMC Medical Co., Ltd.
Anesthesiology · 112d
Cleared Jan 15, 2025
Ventrax™ Delivery System
K242873 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 114d
Cleared Jan 15, 2025
AeroChamber2go Anti-Static Valved Holding Chamber
K242667 · NVP
Trudell Medical International
Anesthesiology · 132d
Cleared Jan 15, 2025
PuraStat
K242634 · PHN
3-D Matrix Europe SAS
Gastroenterology & Urology · 134d
Cleared Jan 15, 2025
GEM ZIPCLIP
K242541 · FZP
Synovis Micro Companies Alliance A...
General & Plastic Surgery · 142d