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
35401–35424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2015
Airlock osteosynthesis plate system
K143523 · HRS
Novastep
Orthopedic · 115d
Cleared Apr 06, 2015
Vertessa Lite
K150016 · OTO
Caldera Medical, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 06, 2015
Vertessa Lite Y-Mesh
K150023 · OTO
Caldera Medical, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 06, 2015
Renu Gel
K150400 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 47d
Cleared Apr 06, 2015
VitreaView
K150738 · LLZ
Vital Images, Inc.
Radiology · 17d
Cleared Apr 03, 2015
ELECTRONIC BLOOD PRESSURE MONITOR
K141683 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 284d
Cleared Apr 03, 2015
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
K142454 · MLR
Advanced Sterilization Products
General Hospital · 213d
Cleared Apr 03, 2015
Aptis Medical Distal Radio Ulnar Joint Implant
K142569 · KXE
Aptis Medical, LLC
Orthopedic · 203d
Cleared Apr 03, 2015
Corin TaperFit Hip Stem
K142761 · JDI
Corin USA
Orthopedic · 190d
Cleared Apr 03, 2015
KIMGUARD ONE-STEP Sterilization Wrap
K143053 · FRG
Kimberly-Clark Health Care
General Hospital · 162d
Cleared Apr 03, 2015
LnK Cervical Interbody Fusion Cage System
K143360 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 130d
Cleared Apr 03, 2015
VAPR Tripolar Suction Electrode
K143475 · GEI
Depuy Mitek
General & Plastic Surgery · 119d
Cleared Apr 03, 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · ELW
Ivoclar Vivadent, Inc.
Dental · 107d
Cleared Apr 03, 2015
Valleylab LS10 Generator
K143654 · GEI
Covidien, LLC
General & Plastic Surgery · 101d
Cleared Apr 03, 2015
Digital Automatic Wrist Blood Pressure Monitor MD2400
K143733 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 94d
Cleared Apr 03, 2015
Arthrex Distal Radius System
K143749 · HRS
Arthrex, Inc.
Orthopedic · 93d
Cleared Apr 03, 2015
CYMA
K150027 · GEX
Whitecap Technologies, LLC
General & Plastic Surgery · 86d
Cleared Apr 03, 2015
2MP Color LCD Monitor, RadiForce RS240
K150106 · PGY
Eizo Corporation
Radiology · 73d
Cleared Apr 03, 2015
Monobond Etch & Prime
K150164 · KLE
Ivoclar Vivadent, AG
Dental · 67d
Cleared Apr 03, 2015
InFill Interbody Fusion Devices
K150206 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 64d
Cleared Apr 03, 2015
Crux Vena Cava Filter System, femoral
K150262 · DTK
Volcano Corporation
Cardiovascular · 58d
Cleared Apr 03, 2015
V8 Transluminal BAV Catheter
K150343 · OZT
Intervalve, Inc.
Cardiovascular · 51d
Cleared Apr 03, 2015
Santis Pedicle Screw System
K150507 · NKB
Lanterna Medical Technologies
Orthopedic · 36d
Cleared Apr 02, 2015
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
K141227 · JXG
Sophysa SA
Neurology · 325d