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
29929–29952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2017
CRYLREX
K161629 · GAM
Sm Eng Co., Ltd.
General & Plastic Surgery · 242d
Cleared Feb 10, 2017
Blood Pressure Monitor
K162089 · DXN
Beijing Choice Electronic Technology...
Cardiovascular · 197d
Cleared Feb 10, 2017
EasyClip Xpress
K162321 · JDR
Restore Surgical, LLC Dba Instratek
Orthopedic · 175d
Cleared Feb 10, 2017
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis...
K162697 · KWS
Custom Orthopaedic Solutions, Inc.
Orthopedic · 136d
Cleared Feb 10, 2017
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
K162774 · DTR
Medtronic, Inc.
Cardiovascular · 130d
Cleared Feb 10, 2017
GORE BIO-A Tissue Reinforcement
K163217 · OXF
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 86d
Cleared Feb 10, 2017
Astroglide Diamond Silicone Gel Personal Lubricant
K163395 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 67d
Cleared Feb 10, 2017
LOGIQ P9 and LOGIQ P7
K163596 · IYN
Ge Healthcare
Radiology · 51d
Cleared Feb 09, 2017
RASL Repair Kit
K161334 · HWC
Radicle Orthopaedics, Inc.
Orthopedic · 273d
Cleared Feb 09, 2017
Low Profile Balloon Feeding Device
K161413 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 262d
Cleared Feb 09, 2017
Scopis Hybrid Navigation System EM
K161491 · PGW
Scopis GmbH
Ear, Nose, Throat · 253d
Cleared Feb 09, 2017
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in...
K161810 · MDB
Becton Dickinson
Microbiology · 223d
Cleared Feb 09, 2017
APTUS® Coronoid 2.0
K161861 · HRS
Medartis AG
Orthopedic · 218d
Cleared Feb 09, 2017
Porcine Anorganic Bone Mineral in Delivery Applicator
K162158 · NPM
Collagen Matrix, Inc.
Dental · 191d
Cleared Feb 09, 2017
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...
K162331 · OCC
Cepheid
Microbiology · 174d
Cleared Feb 09, 2017
PeriFLEX
K162611 · EOQ
Spiration, Inc.
Ear, Nose, Throat · 143d
Cleared Feb 09, 2017
Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single...
K162710 · GDW
Tgs Medical Co., Ltd.
General & Plastic Surgery · 134d
Cleared Feb 09, 2017
Atlas Spine Expandable Interbody System
K162918 · MAX
Atlas Spine, Inc.
Orthopedic · 114d
Cleared Feb 09, 2017
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
K163046 · HRS
DePuy Synthes
Orthopedic · 100d
Cleared Feb 09, 2017
cobas® CT/NG v2.0 Test
K163184 · LSL
Roche Molecular Systems, Inc.
Microbiology · 87d
Cleared Feb 09, 2017
syngo. CT Single Source Dual Energy (twin beam)
K163289 · JAK
Siemens Medical Solutions USA, Inc.,...
Radiology · 79d
Cleared Feb 09, 2017
syngo.CT Extended Functionality
K163341 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Feb 09, 2017
AcuNav Volume ICE Catheter
K163478 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 59d
Cleared Feb 09, 2017
PIVO
K163508 · JKA
Velano Vascular
Chemistry · 57d