Search FDA 510(k) Devices

5,557 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
3097–3120 of 3,225
Cleared Jan 16, 2025
System 9 Sterile Battery Container
K242834 · KCT
Stryker Instruments
General Hospital · 119d
Cleared Jan 16, 2025
WELLlife™ COVID-19 / Influenza A&B Home Test
K243256 · SCA
Wondfo USA Co., Ltd.
Microbiology · 93d
Cleared Jan 16, 2025
ADDNOX (BPSPM1)
K243289 · QGL
Nu Eyne Co., Ltd.
Neurology · 90d
Cleared Jan 16, 2025
Cala kIQ
K243848 · QBC
Cala Health, Inc.
Neurology · 31d
Cleared Jan 16, 2025
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
K243885 · PCH
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Jan 16, 2025
Medi Lift Mask
K244048 · NFO
Ya-Man, Ltd.
Neurology · 16d
Cleared Jan 15, 2025
Venera 608 Deep Vein Thrombosis (DVT) Prevention System
K241096 · JOW
Suzhou Minhua Medical Apparatus...
Cardiovascular · 268d
Cleared Jan 15, 2025
Electrode Pad
K241512 · GXY
Shenzhen Deliduo Medical Technology...
Neurology · 231d
Cleared Jan 15, 2025
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
K242109 · QQX
Cepheid
Microbiology · 180d
Cleared Jan 15, 2025
Micro Ace Gold Advanced Micro Access System
K242229 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 169d
Cleared Jan 15, 2025
GEM ZIPCLIP
K242541 · FZP
Synovis Micro Companies Alliance A...
General & Plastic Surgery · 142d
Cleared Jan 15, 2025
PuraStat
K242634 · PHN
3-D Matrix Europe SAS
Gastroenterology & Urology · 134d
Cleared Jan 15, 2025
AeroChamber2go Anti-Static Valved Holding Chamber
K242667 · NVP
Trudell Medical International
Anesthesiology · 132d
Cleared Jan 15, 2025
Ventrax™ Delivery System
K242873 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 114d
Cleared Jan 15, 2025
Respiration Data Management Software (PAP Link PC)
K242935 · BZD
BMC Medical Co., Ltd.
Anesthesiology · 112d
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
Cardiac Guidance
K243065 · QJU
Caption Health, Inc.
Radiology · 110d
Cleared Jan 15, 2025
RELiZORB (100300/ 100301)
K243284 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 15, 2025
Ziehm Vision RFD
K243328 · OWB
Ziehm Imaging GmbH
Radiology · 83d
Cleared Jan 15, 2025
TriMed Wrist Fixation System (Volar Bearing Plates)
K243569 · HRS
TriMed, Inc.
Orthopedic · 58d
Cleared Jan 15, 2025
FaStep Early Pregnancy Rapid Test Strip
K243573 · LCX
Assure Tech., LLC
Chemistry · 57d
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
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · PZX
AtriCure, Inc.
Cardiovascular · 30d
Cleared Jan 15, 2025
EffortMed Spinal Fixation System
K243946 · NKB
Effortmed, LLC
Orthopedic · 26d