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
16753–16776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2021
Elos® Intramedullary Nailing System
K201147 · HSB
Intrauma S.P.A
Orthopedic · 446d
Cleared Jul 19, 2021
Evolve System with the T3 Applicator
K210877 · PBX
Inmode , Ltd.
General & Plastic Surgery · 117d
Cleared Jul 19, 2021
ENNOVATE Spinal System
K210963 · NKB
Aesculap Implant Systems, LLC
Orthopedic · 110d
Cleared Jul 19, 2021
xvision Spine system (XVS)
K211188 · SBF
Augmedics, Ltd.
Orthopedic · 90d
Cleared Jul 19, 2021
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation...
K211291 · PGW
Fiagon GmbH
Ear, Nose, Throat · 82d
Cleared Jul 19, 2021
POLARSTEM Calcar Reamer Guide
K211548 · LZO
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jul 19, 2021
Z-6 Atrioseptostomy Catheter
K211910 · DXF
NuMED, Inc.
Cardiovascular · 28d
Cleared Jul 17, 2021
Powder Free Vinyl Patient Examination Gloves
K211177 · LYZ
Shijiazhuang Hongjun Plastic...
General Hospital · 88d
Cleared Jul 17, 2021
Vinyl Patient Examination Gloves
K211239 · LYZ
Jiangxi Shengda Medical Technology...
General Hospital · 82d
Cleared Jul 16, 2021
ADVIA Centaur® Digoxin assay
K193397 · KXT
Siemens Healthcare Diagnostics, Inc.
Toxicology · 588d
Cleared Jul 16, 2021
ExoAtlet-II
K201473 · PHL
Exoatlet Asia Co. , Ltd.
Neurology · 408d
Cleared Jul 16, 2021
Ignite Stemless Anatomic Shoulder System
K203108 · PKC
Ignite Orthopedics, LLC
Orthopedic · 274d
Cleared Jul 16, 2021
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope...
K203435 · MHX
Nihon Kohden Corporation
Cardiovascular · 235d
Cleared Jul 16, 2021
JS Dental Lab Mouth Guard
K210011 · MQC
Ampower Dental Laboratories, LLC
Dental · 193d
Cleared Jul 16, 2021
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
K210103 · FMF
Lifelong Meditech Private Limited
General Hospital · 183d
Cleared Jul 16, 2021
PacBond One
K210186 · KLE
Pac-Dent, Inc.
Dental · 172d
Cleared Jul 16, 2021
Medtronic Extended infusion set
K210544 · FPA
Unomedical A/S
Chemistry · 142d
Cleared Jul 16, 2021
Velguard Surgical Face Mask
K210761 · FXX
Esstee Exports Health Care Division
General Hospital · 123d
Cleared Jul 16, 2021
SureMAX-SA Cervical Standalone System
K211111 · OVE
Additive Implants, Inc.
Orthopedic · 93d
Cleared Jul 16, 2021
SwiftNINJA Steerable Microcatheter
K211525 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 60d
Cleared Jul 16, 2021
Avanti Orthopaedics Ulnar Shortening System
K211592 · HRS
Avanti Orthopaedics, Inc.
Orthopedic · 53d
Cleared Jul 16, 2021
StitchKit
K211792 · GAM
Origami Surgical Inc .
General & Plastic Surgery · 36d
Cleared Jul 16, 2021
Soniquence Reusable Bipolar Cable
K211946 · GEI
Soniquence, LLC
General & Plastic Surgery · 23d
Cleared Jul 15, 2021
Crosstex VH2O2 Chemical Indicators
K200096 · JOJ
Crosstex International, Inc. (A...
General Hospital · 546d