FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
23593–23616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2018
UniPulse
K182905 · DRL
Seaward Group
Cardiovascular · 59d
Cleared Dec 14, 2018
MTS Omadacycline 0.002-32 µg/mL
K182922 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Dec 14, 2018
Affixus Hip Fracture Nail
K183162 · HSB
Biomet, Inc.
Orthopedic · 29d
Cleared Dec 13, 2018
BTL-FR2000
K180359 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 307d
Cleared Dec 13, 2018
PYRAMIDION Dental Implants and Prostheses
K180859 · DZE
Dentack Implants, Ltd.
Dental · 255d
Cleared Dec 13, 2018
Accu-Chek Guide Me Blood Glucose Monitoring System
K181131 · NBW
Roche Diabetes Care
Chemistry · 227d
Cleared Dec 13, 2018
Argos
K181372 · DXG
Retia Medical, LLC
Cardiovascular · 204d
Cleared Dec 13, 2018
DuraSheath Introducer Sheath System
K181463 · DYB
Contract Medical International, GmbH
Cardiovascular · 192d
Cleared Dec 13, 2018
CBT Screw Fixation System
K181824 · NKB
U&I Corporation
Orthopedic · 157d
Cleared Dec 13, 2018
ROCCIA® PLIF
K181899 · MAX
Silony Medical GmbH
Orthopedic · 150d
Cleared Dec 13, 2018
EVOLUX CAD/CAM PMMA BLOCKS
K182065 · EBG
Blue Dent Dental
Dental · 134d
Cleared Dec 13, 2018
Erran Dental Zirconia
K182068 · EIH
Hangzhou Erran Technology Co., Ltd.
Dental · 134d
Cleared Dec 13, 2018
neoBLUE blanket LED Phototherapy System
K182178 · LBI
Natus Medical Incorporated
General Hospital · 122d
Cleared Dec 13, 2018
HipCheck
K182359 · LLZ
Stryker Corp.
Radiology · 105d
Cleared Dec 13, 2018
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K182397 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 100d
Cleared Dec 13, 2018
LaparoGuard
K182434 · GCJ
Mariner Endosurgery, Inc.
General & Plastic Surgery · 98d
Cleared Dec 13, 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
StatStrip Xpress Glucose Hospital Meter System
K182552 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
IlluminOss Photodynamic Bone Stabilization System
K183145 · QAD
Illuminoss Medical, Inc.
Orthopedic · 30d
Cleared Dec 13, 2018
Selectra Catheters, Selectra Accessory Kit
K183265 · DQY
Biotronik, Inc.
Cardiovascular · 20d
Cleared Dec 12, 2018
Harvest Dental Polymer Blocks
K180578 · EBG
Harvest Dental Products, LLC
Dental · 282d
Cleared Dec 12, 2018
On1 Universal Abutment
K181869 · NHA
Nobel Biocare AB
Dental · 153d
Cleared Dec 12, 2018
LEUCADIA AUTOLOK™ Pedicle Screw System
K182339 · NKB
Clearview Orthopedic Development, LLC
Orthopedic · 106d
Cleared Dec 12, 2018
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK...
K182473 · KWQ
K2m, Inc.
Orthopedic · 93d