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
28537–28560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2017
Piccolo Composite® Plate System
K170401 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 92d
Cleared May 12, 2017
N Latex Cystatin C
K171072 · NDY
Siemens Healthcare Diagnostics...
Chemistry · 32d
Cleared May 12, 2017
iChemVELOCITY Automated Urine Chemistry System
K171083 · JIL
Iris Diagnostics, A Division of Iris...
Chemistry · 31d
Cleared May 12, 2017
GM85
K171119 · IZL
Samsung Electronics Co., Ltd.
Radiology · 28d
Cleared May 11, 2017
Anybattery C2 Rechargeable Battery
K160667 · DPS
Anybattery, Inc.
Cardiovascular · 428d
Cleared May 11, 2017
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
K161950 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 300d
Cleared May 11, 2017
UniTex Non-Sterile, Powder-Free, Latex Examination Glove
K161961 · LYY
Ug Global Resources Sdn. Bhd.
General Hospital · 297d
Cleared May 11, 2017
Winner Transfer Wheelchair
K162328 · IOR
Winner SG Pte, Ltd.
Physical Medicine · 265d
Cleared May 11, 2017
AIK Sterile Acupuncture Needles for Single Use
K162566 · MQX
Changchun Aik Medical Devices Co., Ltd.
General Hospital · 239d
Cleared May 11, 2017
Kitazato IUI Catheter
K162667 · MQF
Kitazato Corporation
Obstetrics & Gynecology · 227d
Cleared May 11, 2017
A-dec NLZ Electric Motor System
K163131 · EBW
Nakanishi, Inc.
Dental · 184d
Cleared May 11, 2017
Longitudinal Brain Imaging (LoBI) application
K163250 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 174d
Cleared May 11, 2017
Fully Automatic Electronic Blood Pressure Monitor
K163276 · DXN
Andon Health Co, Ltd.
Cardiovascular · 171d
Cleared May 11, 2017
GORE SYNECOR Preperitoneal Biomaterial
K163576 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 143d
Cleared May 11, 2017
Lung Vision
K163622 · LLZ
Bodyvision Medical , Ltd.
Radiology · 140d
Cleared May 11, 2017
TREFOIL System
K170135 · DZE
Nobel Biocare AB
Dental · 114d
Cleared May 11, 2017
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
K170205 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 108d
Cleared May 11, 2017
Arthrex Compression Screws
K170382 · HWC
Arthrex, Inc.
Orthopedic · 93d
Cleared May 11, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR...
K170413 · LIP
Bio-Rad Laboratories
Microbiology · 90d
Cleared May 11, 2017
SurgiCase Viewer
K170419 · LLZ
Materialise NV
Radiology · 87d
Cleared May 11, 2017
Solana C. difficile Assay
K170491 · OZN
Quidel Corporation
Microbiology · 83d
Cleared May 11, 2017
Mako Total Knee Application
K170581 · OLO
Mako Surgical Corp.
Orthopedic · 72d
Cleared May 11, 2017
Mako Partial Knee Application
K170584 · OLO
Mako Surgical Corp.
Orthopedic · 72d
Cleared May 11, 2017
Connector System
K170647 · NKG
Orthofix, Inc.
Orthopedic · 69d