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
33337–33360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2015
MotoBand¿ CP Implant System
K152306 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 119d
Cleared Dec 11, 2015
VINTAGE Art LF
K152451 · EIH
Shofu Dental Corporation
Dental · 105d
Cleared Dec 11, 2015
GORE SYNECOR Biomaterial
K152609 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 88d
Cleared Dec 11, 2015
DR 600
K152639 · MQB
Agfa Healthcare N.V.
Radiology · 87d
Cleared Dec 11, 2015
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Dec 11, 2015
Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System
K152987 · ODP
Xenco Medical, LLC
Orthopedic · 59d
Cleared Dec 11, 2015
iViewDose R1.0
K153011 · IYE
Elekta Limited
Radiology · 58d
Cleared Dec 11, 2015
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced...
K153088 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 46d
Cleared Dec 11, 2015
BD FlowSmart Set, MiniMed Pro-Set
K153257 · FPA
Becton, Dickinson and Company
General Hospital · 31d
Cleared Dec 11, 2015
SpeedLock Knotless Fixation System
K153313 · MBI
ArthroCare Corporation
Orthopedic · 24d
Cleared Dec 11, 2015
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm,...
K153461 · KNT
Maquet Critical Care AB
Gastroenterology & Urology · 10d
Cleared Dec 10, 2015
OneQ-SL Implant System
K142313 · DZE
Dentis Co., Ltd.
Dental · 478d
Cleared Dec 10, 2015
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
K150079 · NPM
Nibec Co., Ltd.
Dental · 329d
Cleared Dec 10, 2015
PAPAYA 3D Plus
K150354 · OAS
Genoray Co., Ltd.
Radiology · 302d
Cleared Dec 10, 2015
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T...
K150708 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 266d
Cleared Dec 10, 2015
Checkme Pro Health Monitor
K150869 · MWI
Viatom Technology Co., Ltd.
Cardiovascular · 253d
Cleared Dec 10, 2015
ALP VasQcare Take Home System
K151158 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 223d
Cleared Dec 10, 2015
BEAUTIFIL II Enamel
K151699 · EBF
Shofu Dental Corporation
Dental · 169d
Cleared Dec 10, 2015
BRX PRO Bruxism Guard
K151933 · MQC
12th Man Technologies, Inc.
Dental · 149d
Cleared Dec 10, 2015
Sterile Repositionable Hemostasis Clipping Device
K152001 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 143d
Cleared Dec 10, 2015
Fuse Gastroscopy System
K152182 · FDS
Endochoice, Inc.
Gastroenterology & Urology · 127d
Cleared Dec 10, 2015
Biomet Microfixation OmniMax MMF System
K152326 · JEY
Biomet Microfixation
Dental · 114d
Cleared Dec 10, 2015
Twin Peaks Lumbar Interbody Fusion System
K152355 · MAX
Spineway
Orthopedic · 112d
Cleared Dec 10, 2015
AOS Small Fragment Plating System
K152732 · HRS
Avanced Orthopaedic Solutions, Inc....
Orthopedic · 79d