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
33433–33456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2015
NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System,...
K150561 · HRS
Narang Medical Limited
Orthopedic · 264d
Cleared Nov 25, 2015
Contour Next USB Blood Glucose Monitoring System
K150942 · NBW
Bayer Healthcare
Chemistry · 231d
Cleared Nov 25, 2015
CORVUS Radiation Therapy Planning System
K151469 · MUJ
Best Nomos
Radiology · 177d
Cleared Nov 25, 2015
HEARTWAY Power Mobility Scooter
K151656 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 159d
Cleared Nov 25, 2015
SMV Scientific Bone Plate and Screw System
K152000 · HRS
Smv Scientific
Orthopedic · 128d
Cleared Nov 25, 2015
DERMABOND PRINEO Skin Closure System
K152490 · OMD
Ethicon, Inc.
General & Plastic Surgery · 85d
Cleared Nov 25, 2015
Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
K152494 · JWH
Zimmer, Inc.
Orthopedic · 85d
Cleared Nov 25, 2015
4Sight
K152573 · IYO
Accutome, Inc.
Radiology · 77d
Cleared Nov 25, 2015
Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care...
K152761 · IYE
Varian Medical Systems, Inc.
Radiology · 62d
Cleared Nov 25, 2015
Avex CX2
K152779 · NJM
Opal Orthodontics by Ultradent Products
Dental · 61d
Cleared Nov 25, 2015
XIDF-AWS801, Angio Workstation, V6.20
K152785 · OWB
Toshibamedical Systems Corporation
Radiology · 61d
Cleared Nov 25, 2015
VidiStar HeartView
K152822 · LLZ
Vidistar, LLC
Radiology · 58d
Cleared Nov 25, 2015
Picasso Plus, Picasso Lite Plus
K152939 · GEX
Amd Group, LLC
General & Plastic Surgery · 51d
Cleared Nov 25, 2015
LARIAT RS Suture Delivery Device
K153096 · GAT
Sentreheart, Inc.
General & Plastic Surgery · 30d
Cleared Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
K153142 · MQB
Carestream Health, Inc.
Radiology · 26d
Cleared Nov 25, 2015
Tyber Medical MST Trauma Screw
K153180 · HWC
Tyber Medical, LLC
Orthopedic · 22d
Cleared Nov 25, 2015
SELF- COMPRESSIVE SCREW
K153182 · HWC
Neosteo
Orthopedic · 22d
Cleared Nov 24, 2015
LUXATOR LX HANDPIECE
K133178 · EGS
Directa AB
Dental · 768d
Cleared Nov 24, 2015
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM...
K142955 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 406d
Cleared Nov 24, 2015
SilverCoat Silicone Foley Catheter
K150550 · EZL
Covalontechnologies, Inc.
Gastroenterology & Urology · 266d
Cleared Nov 24, 2015
PENTAX Medical EPK-i7010 Video Processor with GI Family
K150618 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 259d
Cleared Nov 24, 2015
AVAflex Vertebral Balloon System
K151125 · HRX
Care Fusion
Orthopedic · 210d
Cleared Nov 24, 2015
OES ELITE Telescopes, Protective Tube
K151191 · FBP
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 204d
Cleared Nov 24, 2015
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose...
K151265 · NBW
Sd Biosensor
Chemistry · 195d