Search FDA 510(k) Devices

5,755 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
3985–4008 of 174,061
Cleared Dec 20, 2024
HPR Cordless Hygiene Handpiece
K243911 · EKX
Handpiece Headquarters
Dental · 1d
Cleared Dec 20, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)...
K243759 · PEN
Biofire Diagnostics, LLC
Microbiology · 14d
Cleared Dec 20, 2024
InkSpace Imaging Small Body Array
K243675 · MOS
Inkspace Imaging, Inc.
Radiology · 23d
Cleared Dec 20, 2024
ExcelsiusGPS® Instruments
K243671 · OLO
Globus Medical, Inc.
Orthopedic · 23d
Cleared Dec 20, 2024
Momcozy Wearable Breast Pump (BP311)
K243629 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 25d
Cleared Dec 20, 2024
Moda-flx Hemodialysis System™ Cartridge (102121-001 )
K243607 · FJK
Diality, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 20, 2024
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System,...
K243308 · HRS
Bonebridge AG
Orthopedic · 60d
Cleared Dec 20, 2024
Zimmer® Persona® Personalized Knee System
K243293 · MBH
Zimmer Biomet
Orthopedic · 63d
Cleared Dec 20, 2024
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
K243149 · QLY
Congruence Medical Solutions, LLC
General Hospital · 81d
Cleared Dec 20, 2024
LED Light Therapy Mask...
K243040 · OHS
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 84d
Cleared Dec 20, 2024
Cellbrick Knee Spacer
K243024 · JWH
United Orthopedic Corporation
Orthopedic · 84d
Cleared Dec 20, 2024
KIDS Arterial Filters
K242953 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Dec 20, 2024
Fas Aligner System
K242929 · NXC
Xplora 3D Europe S.L
Dental · 87d
Cleared Dec 20, 2024
SimpleSnip Endoscopic Suture Cutter (SC500160)
K242923 · OCZ
Envision Endoscopy
Gastroenterology & Urology · 87d
Cleared Dec 20, 2024
Finiff System
K242688 · GEI
Skingrab Co., Ltd.
General & Plastic Surgery · 105d
Cleared Dec 20, 2024
SENDERO MAX Delivery Catheter
K242644 · DQY
Okami Medical, Inc.
Cardiovascular · 108d
Cleared Dec 20, 2024
Scooter (PS30)
K242628 · INI
Lichtmega Technology Co., Ltd.
Physical Medicine · 108d
Cleared Dec 20, 2024
aprevo® Digital Planning
K242599 · LLZ
Carlsmed, Inc.
Radiology · 112d
Cleared Dec 20, 2024
TopCEM-Try in Veneer Try-in Gel
K242572 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 113d
Cleared Dec 20, 2024
HandPICO Fractional Laser Handpiece Tip
K242534 · GEX
Vydence Medical
General & Plastic Surgery · 116d
Cleared Dec 20, 2024
HF-Etchant Hydrofluoric Acid Etching Gel
K242530 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 116d
Cleared Dec 20, 2024
Tigon Medical All-Suture Anchors (ASA)
K242529 · MBI
Tigon Medical
Orthopedic · 116d
Cleared Dec 20, 2024
Lightning Viewer
K242362 · LLZ
Nexsys Electronics Inc. Dba Medweb
Radiology · 133d
Cleared Dec 20, 2024
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620)
K242281 · FOZ
Arrow International, LLC (A...
General Hospital · 140d