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
4705–4728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 15, 2025
Micro Ace Gold Advanced Micro Access System
K242229 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 169d
Cleared Jan 15, 2025
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
K242109 · QQX
Cepheid
Microbiology · 180d
Cleared Jan 15, 2025
Electrode Pad
K241512 · GXY
Shenzhen Deliduo Medical Technology...
Neurology · 231d
Cleared Jan 15, 2025
Venera 608 Deep Vein Thrombosis (DVT) Prevention System
K241096 · JOW
Suzhou Minhua Medical Apparatus...
Cardiovascular · 268d
Cleared Jan 14, 2025
Elegance® Anterior Cervical plate
K243904 · KWQ
Clariance
Orthopedic · 26d
Cleared Jan 14, 2025
Radical the Dude 8F Guide Catheter
K243577 · QJP
Maduro Medical, Inc.
Neurology · 56d
Cleared Jan 14, 2025
Orthoscan VERSA Mini C-Arm
K243452 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 68d
Cleared Jan 14, 2025
APRO 70 Swift Catheter
K243297 · QJP
Alembic, LLC
Neurology · 88d
Cleared Jan 14, 2025
LOCATOR Angled Abutment
K243272 · NHA
Zest Anchors, LLC
Dental · 90d
Cleared Jan 14, 2025
Zoom System
K242672 · NRY
Imperative Care, Inc.
Neurology · 130d
Cleared Jan 14, 2025
SpectoMed (v1.0)
K242205 · LLZ
Specto Medical
Radiology · 172d