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
29761–29784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2016
MRidium 3860+ MRI infusion Pump/ Monitoring System
K143369 · FRN
Iradimed Corporation
General Hospital · 751d
Cleared Dec 15, 2016
IPS e.max® Press Abutment Solutions for Viteo Base Ti
K160798 · NHA
Ivoclar Vivadent, AG
Dental · 267d
Cleared Dec 15, 2016
Menai System
K160836 · BZD
Resmed, Ltd.
Anesthesiology · 265d
Cleared Dec 15, 2016
WS(TM) Far-Infrared Therapy Unit, Model KP-B210
K160849 · ILY
Ws Far IR Medical Technology Co., Ltd.
Physical Medicine · 262d
Cleared Dec 15, 2016
Zia
K160852 · LLZ
Zetta Medical Technologies, LLC
Radiology · 262d
Cleared Dec 15, 2016
Arthrex iBalance UKA System Vitamin E Tibial Bearing
K161060 · HSX
Arthrex, Inc.
Orthopedic · 244d
Cleared Dec 15, 2016
BluePro
K162192 · LRK
Bluesom
Dental · 133d
Cleared Dec 15, 2016
PERMATAPE
K162247 · GAT
Medos International SARL
General & Plastic Surgery · 127d
Cleared Dec 15, 2016
Pulsaderm ACE-All Blue
K162371 · OLP
Nutra Luxe MD, LLC
General & Plastic Surgery · 113d
Cleared Dec 15, 2016
INTRABEAM 600
K162568 · JAD
Carl Zeiss Meditec, AG
Radiology · 92d
Cleared Dec 15, 2016
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K162845 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 65d
Cleared Dec 15, 2016
ARIETTA Prologue Diagnostic Ultrasound system and Transducers
K162902 · IYN
Hitachi , Ltd.
Radiology · 59d
Cleared Dec 15, 2016
SMD-Sr90-DA Radionuclide Brachytherapy Source
K163206 · KXK
Salutaris Medical Devices, Inc.
Radiology · 30d
Cleared Dec 15, 2016
6MP Color LCD Monitor, RadiForce RX660, RX660-AR
K163335 · PGY
Eizo Corporation
Radiology · 17d
Cleared Dec 15, 2016
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
K163336 · NUA
Luminex Molecular Diagnostics, Inc.
Medical Genetics · 17d
Cleared Dec 15, 2016
xTAG Cystic Fibrosis 39 Kit v2
K163347 · NUA
Luminex Molecular Diagnostics, Inc.
Medical Genetics · 17d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized...
K160225 · JGS
Instrumentation Laboratory CO
Chemistry · 320d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · CGA
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160412 · CHL
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin,...
K160415 · GKF
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
Ritter Dental Implant System
K160475 · DZE
Ritter Implants GmbH CO KG
Dental · 299d
Cleared Dec 14, 2016
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
K160915 · OVK
Roche Diagnostics
Immunology · 257d
Cleared Dec 14, 2016
OXINIUM DH Fermoral Heads
K161233 · MBL
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared Dec 14, 2016
Integrity-SI TM Fusion System
K161755 · OUR
Coorstek Medical
Orthopedic · 170d