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
23257–23280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2019
“BRAXX” Esophageal Brachytherapy Applicator
K183332 · JAQ
Braxx Biotech Co., Ltd.
Radiology · 134d
Cleared Apr 16, 2019
Avulsion Forceps
K183428 · KGE
STERIS Corporation
Gastroenterology & Urology · 126d
Cleared Apr 16, 2019
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm...
K183619 · FAE
Boston Scientific Corporation
Gastroenterology & Urology · 111d
Cleared Apr 16, 2019
Elecsys TSH
K190773 · JLW
Roche Diagnostics
Chemistry · 21d
Cleared Apr 15, 2019
Rigi10 Malleable Penile Prosthesis
K181673 · FAE
Rigicon, Inc.
Gastroenterology & Urology · 294d
Cleared Apr 15, 2019
One Touch
K181844 · HIS
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 278d
Cleared Apr 15, 2019
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
K182272 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 236d
Cleared Apr 15, 2019
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
K182828 · NLM
Surgical Instrument Service and...
General & Plastic Surgery · 192d
Cleared Apr 15, 2019
Diode Laser Treatment System
K182924 · GEX
Weifang KM Electronics Co., Ltd.
General & Plastic Surgery · 178d
Cleared Apr 15, 2019
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16
K183548 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Apr 15, 2019
BriefCase
K190072 · QAS
Aidoc Medical , Ltd.
Radiology · 90d
Cleared Apr 15, 2019
PreXion3D Explorer
K190320 · OAS
Prexion Corporation
Radiology · 61d
Cleared Apr 15, 2019
NDOHD High Definition Imaging System (NDOHD)
K190420 · LLZ
Altaravision, Inc.
General & Plastic Surgery · 53d
Cleared Apr 15, 2019
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test...
K190705 · LCX
Wholepower Biotech Co., Ltd.
Chemistry · 27d
Cleared Apr 13, 2019
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy...
K190690 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 26d
Cleared Apr 12, 2019
D-Clip
K180757 · HCH
Peter Lazic GmbH
Neurology · 386d
Cleared Apr 12, 2019
Ascent Cardiorespiratory Diagnostic Software
K181912 · BTY
Medical Graphics Corporation
Anesthesiology · 269d
Cleared Apr 12, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K181915 · LCP
Ixensor Co, Ltd.
Chemistry · 269d
Cleared Apr 12, 2019
KardiaMobile, KardiaStation
K182396 · DXH
AliveCor, Inc.
Cardiovascular · 220d
Cleared Apr 12, 2019
InstaRISPACS / InstaZFP / InstaMobi v5.0
K182572 · LLZ
Meddiff Technologies Pvt. , Ltd.
Radiology · 206d
Cleared Apr 12, 2019
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K182619 · PEN
Genmark Diagnostics, Incorporated
Microbiology · 200d
Cleared Apr 12, 2019
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet...
K182640 · LZA
Shandong Hengya Packaging Printing...
General Hospital · 200d
Cleared Apr 12, 2019
3T 32 Channel Head Coil
K182737 · MOS
Nova Medical, Inc.
Radiology · 196d
Cleared Apr 12, 2019
TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner...
K182891 · PSW
Cs Medical, LLC
General Hospital · 179d