FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
11137–11160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2023
The Heart Seat
K222330 · MWI
Casana Care, Inc.
Cardiovascular · 265d
Cleared Apr 24, 2023
Kisar Stratford SI Screw System
K220274 · OUR
Anjali Investments L.L.C
Orthopedic · 448d
Cleared Apr 24, 2023
NEST-C Interbody System
K220261 · ODP
Paonan Biotech Co., Ltd.
Orthopedic · 448d
Cleared Apr 21, 2023
OmniGuide RFID Surgical Laser Fibers
K230819 · GEX
Omni-Guide Holdings, Inc.
General & Plastic Surgery · 28d
Cleared Apr 21, 2023
Intense Pulsed Light Treatment System
K230816 · ONF
Shangdong Huamei Technology Co., Ltd.
General & Plastic Surgery · 28d
Cleared Apr 21, 2023
Digital Intraoral X-Ray Sensor
K230811 · MUH
Iray Imaging Technology (Haining)...
Radiology · 28d
Cleared Apr 21, 2023
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
K230808 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 29d
Cleared Apr 21, 2023
Knee+
K230789 · SBF
Pixee Medical
Orthopedic · 30d
Cleared Apr 21, 2023
Anatase Spine Surgery Navigation System
K230783 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared Apr 21, 2023
EzDent Web
K230468 · LLZ
Ewoosoft Co., Ltd.
Radiology · 59d
Cleared Apr 21, 2023
HERA W10 Diagnostic Ultrasound System
K230084 · IYN
Samsung Medison Co., Ltd.
Radiology · 100d
Cleared Apr 21, 2023
ViewFinder Software Version 1.1
K223501 · QIH
Elaitra, Ltd.
Radiology · 151d
Cleared Apr 21, 2023
Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle,...
K223300 · KNW
Geotek Medikal Ltd Sti
General & Plastic Surgery · 176d
Cleared Apr 21, 2023
Modular Rotating Hinge Knee Systems and Compatible Components
K223069 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 203d
Cleared Apr 21, 2023
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill...
K222604 · MQC
Dentona AG
Dental · 235d
Cleared Apr 21, 2023
Paradigm System
K222291 · OLO
Proprio, Inc.
Orthopedic · 263d
Cleared Apr 21, 2023
AEON Endoscopic Stapler
K222210 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 270d
Cleared Apr 21, 2023
CONNEQT PULSE
K221742 · DXN
Atcor Medical
Cardiovascular · 310d
Cleared Apr 21, 2023
Kyphoplasty Balloon System
K221142 · HRX
OK Medinet Korea Co., Ltd.
Orthopedic · 367d
Cleared Apr 20, 2023
Deep Learning Image Reconstruction
K230807 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Apr 20, 2023
Precision1, Precision1 for Astigmatism
K230785 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Apr 20, 2023
HILINE™ Fixation System
K230565 · OWI
Globus Medical, Inc.
Orthopedic · 50d
Cleared Apr 20, 2023
RadiForce RX270
K223768 · PGY
Eizo Corporation
Radiology · 126d
Cleared Apr 20, 2023
Neodent Implant System - Helix Short Surgical Kit Cases
K223662 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 135d