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
27361–27384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Sep 26, 2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit,...
K171963 · OCC
Hologic, Inc.
Microbiology · 88d
Cleared Sep 26, 2017
SculpSure
K171992 · PKT
Cynosure, Inc.
General & Plastic Surgery · 85d
Cleared Sep 26, 2017
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
K172015 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 85d
Cleared Sep 26, 2017
ROMEO® 2 Posterior Osteosynthesis System
K172101 · NKB
Spineart
Orthopedic · 76d
Cleared Sep 26, 2017
CareView 1800Cw X-ray Flat Panel Detectors
K172581 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 29d
Cleared Sep 25, 2017
ISEN-Goggles with Data Viewer
K163270 · GWN
Isent Tech & Trading Company, Ltd.
Neurology · 308d
Cleared Sep 25, 2017
Ecofit® Hip System
K163577 · LZO
Implantcast GmbH
Orthopedic · 279d
Cleared Sep 25, 2017
INDEPENDENCE® Spacers
K170157 · OVD
Globus Medical, Inc.
Orthopedic · 250d
Cleared Sep 25, 2017
Urbanek Device
K170985 · MQC
Tmj Services, LLC
Dental · 175d
Cleared Sep 25, 2017
Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)
K171161 · MQV
Dimensional Bioceramics, LLC
Orthopedic · 158d
Cleared Sep 25, 2017
Exofin Fusion Skin Closure System
K171442 · OMD
Chemence Medical, Inc.
General & Plastic Surgery · 132d
Cleared Sep 25, 2017
LapBag
K171726 · GCJ
Sejong Medical Co., Ltd.
General & Plastic Surgery · 105d
Cleared Sep 25, 2017
GALAXY G3 Mini Microcoil Delivery System
K171862 · HCG
Codman & Shurtleff, Inc.
Neurology · 95d
Cleared Sep 25, 2017
Electrocardiograph
K171943 · DPS
Edan Instruments, Inc.
Cardiovascular · 89d
Cleared Sep 25, 2017
Xpert Xpress Strep A
K172126 · PGX
Cepheid
Microbiology · 73d
Cleared Sep 25, 2017
PRECICE System
K172628 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 24d
Cleared Sep 24, 2017
Powder-free Clear Vinyl Patient Examination Gloves
K171460 · LYZ
Shandong Zhiwei Medical Products, Co....
General Hospital · 129d
Cleared Sep 22, 2017
Straumann CARES Golden Ti/TiN Abutments
K162848 · NHA
Institut Straumann AG
Dental · 346d
Cleared Sep 22, 2017
NOWCARDIO SYSTEM
K162956 · QYX
Contex International Technologies...
Cardiovascular · 333d
Cleared Sep 22, 2017
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera,...
K163674 · NUC
Neo Cosmetique
Obstetrics & Gynecology · 269d
Cleared Sep 22, 2017
Thermage FLX System and Accessories
K170758 · GEI
Solta Medical
General & Plastic Surgery · 193d
Cleared Sep 22, 2017
SYSTEM 1E Liquid Chemical Sterilant Processing System
K170956 · MED
STERIS Corporation
General Hospital · 175d
Cleared Sep 22, 2017
TempSure
K171262 · GEI
Cynosure, Inc.
General & Plastic Surgery · 144d