Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
36145–36168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2015
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K143483 · CFF
Sebia
Immunology · 31d
Cleared Jan 08, 2015
ANUTRA Feedback Aspiration Syringe
K143757 · FMF
Anutra Medical, Inc.
General Hospital · 8d
Cleared Jan 07, 2015
MAXIMIS SPINAL FIXATION SYSTEM
K140359 · MNH
Valorem Surgical
Orthopedic · 329d
Cleared Jan 07, 2015
ENDOPHYS PRESSURE SENSING SHEATH KIT
K141275 · DYB
Endophys, Inc.
Cardiovascular · 236d
Cleared Jan 07, 2015
AED HYSTEROSCOPE AND ACCESSORIES
K141515 · HIH
National Advanced Endoscopy Devices,...
Obstetrics & Gynecology · 212d
Cleared Jan 07, 2015
ENDOPHYS BLOOD PRESSURE MONITOR
K141615 · DSK
Endophys, Inc.
Cardiovascular · 205d
Cleared Jan 07, 2015
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity...
K141689 · DCK
Qualigen, Inc.
Chemistry · 198d
Cleared Jan 07, 2015
HILTHERA 4.0
K141861 · ILY
Jeisys Medical, Inc.
Physical Medicine · 181d
Cleared Jan 07, 2015
Applied BioPhotonics Phototherapy System ABPT1003
K142256 · ILY
Applied Biophotonics , Ltd.
Physical Medicine · 146d
Cleared Jan 07, 2015
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
K142447 · DXZ
Synovis Life Technologies, Inc.
Cardiovascular · 127d
Cleared Jan 07, 2015
Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC...
K142667 · DZE
Sterngold Dental, LLC
Dental · 110d
Cleared Jan 07, 2015
Unity Network ID
K142840 · MWI
Ge Healthcare
Cardiovascular · 99d
Cleared Jan 07, 2015
DLP Vein Graft Cannula
K143107 · DWF
Medtronic, Inc.
Cardiovascular · 70d
Cleared Jan 07, 2015
Ufi Gel hard C
K143486 · EBI
Voco GmbH
Dental · 30d
Cleared Jan 06, 2015
MR-CT VVA
K140587 · LLZ
Medis Medical Imaging Systems BV
Radiology · 305d
Cleared Jan 06, 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW...
K140722 · JXG
Integra LifeSciences Corporation
Neurology · 291d
Cleared Jan 06, 2015
IFS ADVANCED FEMTOSECOND LASER SYSTEM
K141852 · GEX
Amo Manufacturing USA, LLC
General & Plastic Surgery · 181d
Cleared Jan 06, 2015
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X
K141923 · NHA
Prismatik Dentalcraft, Inc.
Dental · 174d
Cleared Jan 06, 2015
IMPAX Agility
K142316 · LLZ
Agfa Healthcare N.V.
Radiology · 140d
Cleared Jan 06, 2015
McKesson Radiology Mammography Plus
K142850 · LLZ
Mckesson Medical Imaging Company
Radiology · 98d
Cleared Jan 05, 2015
MADM
K140264 · BSZ
Thornhill Research, Inc.
Anesthesiology · 336d
Cleared Jan 05, 2015
zenostar MO, Zenostar T, Zenostar VisualiZr
K142233 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 145d
Cleared Jan 05, 2015
S9 Portable Digital Color Doppler Ultrasound System
K142710 · IYN
Sonoscape Company Limited
Radiology · 105d
Cleared Jan 05, 2015
Arsenal Spinal Fixation System
K143149 · NKB
Alphatec Spine, Inc.
Orthopedic · 63d