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
3049–3072 of 3,225
Cleared Jan 22, 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · LHI
Icu Medical, Inc.
General Hospital · 30d
Cleared Jan 21, 2025
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011)
K241443 · NUC
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology · 244d
Cleared Jan 21, 2025
Biliary Pancreaticobiliary Scope System
K241444 · FBN
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 244d
Cleared Jan 21, 2025
Advanced Cryo Wart Remover
K242288 · GEH
Medical Brands Laboratories B.V.
General & Plastic Surgery · 172d
Cleared Jan 21, 2025
Ziehm Vision RFD 3D
K243303 · OWB
Ziehm Imaging GmbH
Radiology · 92d
Cleared Jan 21, 2025
Oligio X
K243929 · GEI
Wontech Co., Ltd.
General & Plastic Surgery · 32d
Cleared Jan 21, 2025
Precision AI Surgical Planning System (PAI-SPS)
K243955 · QHE
Precision AI Pty, Ltd.
Orthopedic · 29d
Cleared Jan 19, 2025
Neonav ECG Tip Location System
K241910 · LJS
Navi Medical Technologies
Cardiovascular · 202d
Cleared Jan 17, 2025
cobas® liat CT/NG nucleic acid test
K240217 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d
Cleared Jan 17, 2025
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and...
K241142 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 267d
Cleared Jan 17, 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial...
K241261 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 266d
Cleared Jan 17, 2025
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO...
K241269 · ETA
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 268d
Cleared Jan 17, 2025
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K241333 · HAW
KOH YOUNG TECHNOLOGY, Inc.
Neurology · 252d
Cleared Jan 17, 2025
Digital Color Doppler Ultrasound System (P60 Series)
K241949 · IYN
Sonoscape Medical Corp.
Radiology · 198d
Cleared Jan 17, 2025
VersaD Delivery Catheter
K242051 · QJP
Unity Medical, Inc.
Neurology · 189d
Cleared Jan 17, 2025
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)
K242064 · NHA
Smart Denture Conversions, LLC
Dental · 186d
Cleared Jan 17, 2025
TechCare Trauma
K242171 · QBS
Milvue
Radiology · 177d
Cleared Jan 17, 2025
hygh-tec Drainage II
K242336 · KNT
Amb Medtec
Gastroenterology & Urology · 163d
Cleared Jan 17, 2025
ULSPIRA TS™ Nitric Oxide Therapy System
K242374 · MRN
Airgas Therapeutics, LLC
Anesthesiology · 161d
Cleared Jan 17, 2025
Embozene Color-Advanced Microspheres
K242608 · KRD
Varian Medical Systems, Inc.
Gastroenterology & Urology · 136d
Cleared Jan 17, 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline...
K242705 · LDF
Medtronic, Inc.
Cardiovascular · 130d
Cleared Jan 17, 2025
Electronic Apex Locator (Alpha Apex I)
K242765 · LQY
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 126d
Cleared Jan 17, 2025
Prenuvo Body Composition
K242825 · LNH
Prenuvo
Radiology · 121d
Cleared Jan 17, 2025
Type 5 Integrating Indicator for Steam (CSPN-15)
K242860 · JOJ
True Indicating, LLC
General Hospital · 119d