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
24001–24024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2019
Wireless Digital Flat Detector
K183713 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Jan 08, 2019
Park Dental Research Aligners
K180648 · NXC
Park Dental Research Corporation
Dental · 301d
Cleared Jan 08, 2019
TruShot with Y-Knot Shallow All-Suture Anchor
K182439 · MBI
Conmed Corporation
Orthopedic · 123d
Cleared Jan 08, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K182630 · LZG
Insulet Corporation
General Hospital · 106d
Cleared Jan 08, 2019
HS30 Diagnostic Ultrasound System
K182632 · IYN
Samsung Medison Co., Ltd.
Radiology · 106d
Cleared Jan 08, 2019
BD MAX CTGCTV2, BD MAX System
K182692 · OUY
Becton, Dickinson and Company
Microbiology · 103d
Cleared Jan 08, 2019
Choice Spine Navigation System
K182721 · OLO
Choicespine, LP
Orthopedic · 102d
Cleared Jan 08, 2019
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
K182868 · MUD
Covidien, LLC
General & Plastic Surgery · 88d
Cleared Jan 07, 2019
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM...
K180564 · NHA
Medentika GmbH
Dental · 308d
Cleared Jan 07, 2019
FlareHawk Interbody Fusion System
K182114 · MAX
Integrity Implants, Inc.
Orthopedic · 154d
Cleared Jan 07, 2019
TiWAVE-L Porous Titanium Lumbar Cage
K182210 · MAX
Kalitec Medical, LLC
Orthopedic · 145d
Cleared Jan 07, 2019
Stryker Facial iD Plating System
K182305 · JEY
Stryker
Dental · 136d
Cleared Jan 07, 2019
Precision Ideal Eyes Arthroscopes
K183470 · HRX
Stryker
General & Plastic Surgery · 24d
Cleared Jan 04, 2019
BIO-C TEMP
K180199 · KIF
Angelus Industria DE Produtos...
Dental · 345d
Cleared Jan 04, 2019
Straumann PURE Ceramic Implant System
K180477 · DZE
Institut Straumann AG
Dental · 316d
Cleared Jan 04, 2019
Care Orchestrator
K181053 · BZD
Respironics, Inc.
Anesthesiology · 259d
Cleared Jan 04, 2019
Rapid-i™ Kit
K181461 · MQK
Vitrolife Sweden AB
Obstetrics & Gynecology · 214d
Cleared Jan 04, 2019
CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver
K182621 · MBI
Conmed Corporation
Orthopedic · 102d
Cleared Jan 04, 2019
Polygon Resection Device
K182675 · HIH
Polygon Medical, Inc.
Obstetrics & Gynecology · 100d
Cleared Jan 04, 2019
BridalVeil Navigated Instruments
K182982 · OLO
Astura Medical
Orthopedic · 67d
Cleared Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K183033 · JWY
Thermo Fisher Scientific
Microbiology · 64d
Cleared Jan 04, 2019
BostonSight Scleral
K183175 · HQD
Bostonsight
Ophthalmic · 49d
Cleared Jan 04, 2019
GlideScope BFlex Single-Use Bronchoscope System
K183256 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 44d
Cleared Jan 04, 2019
VERIFY VH202 Indicator Tape
K183293 · JOJ
STERIS Corporation
General Hospital · 38d