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
29473–29496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2017
SurgTech Thoracolumbosacral (TLS) Posterior Fixation System
K163363 · NKB
Surgtech, Inc.
Orthopedic · 126d
Cleared Apr 05, 2017
Entellus Medical Reinforced Anesthesia Needle
K163435 · BSP
Entellus Medical, Inc.
Anesthesiology · 119d
Cleared CT Apr 05, 2017
XprESS ENT Dilation System
K163509 · PNZ
Entellus Medical, Inc.
Ear, Nose, Throat · 111d
Cleared Apr 05, 2017
IQon Spectral CT
K163711 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 96d
Cleared Apr 05, 2017
TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO...
K170377 · GEI
Richard Wolf Medical Instruments...
General & Plastic Surgery · 57d
Cleared Apr 05, 2017
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K170456 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 49d
Cleared Apr 05, 2017
HeartSpan Steerable Sheath Introducer
K170668 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Apr 05, 2017
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
K170677 · GWF
Neurovision Medical Product, Inc.
Neurology · 30d
Cleared Apr 05, 2017
Anzai Respiratory Gating System
K170719 · LHN
Anzai Medical Co., Ltd.
Radiology · 27d
Cleared Apr 05, 2017
Nio Color 3MP (MDNC-3421)
K170837 · PGY
Barco N.V.
Radiology · 15d
Cleared Apr 04, 2017
Zavation IBF
K162206 · MAX
Zavation, LLC
Orthopedic · 242d
Cleared Apr 04, 2017
OsteoMed PINNACLE Driver
K162544 · KMW
Osteomed
Dental · 204d
Cleared Apr 04, 2017
iHelmet Hair Growth System
K162782 · OAP
Slinph Technologies Co., Ltd.
General & Plastic Surgery · 183d
Cleared Apr 04, 2017
Mazor X
K163221 · OLO
Mazor Robotics , Ltd.
Orthopedic · 139d
Cleared Apr 04, 2017
OsteoMed ExtremiFix Mid and Large Screw System
K163303 · HWC
Osteomed, LLC
Orthopedic · 133d
Cleared Apr 04, 2017
Zenysis Short-Term Dialysis Catheter
K163458 · MPB
C.R. Bard, Inc.
Gastroenterology & Urology · 116d
Cleared Apr 04, 2017
Nihon Kohden Vital Sign Telemeter
K163459 · MHX
Nihon Kohden Corporation
Cardiovascular · 116d
Cleared Apr 04, 2017
Bluephase Style 20i
K163613 · EBZ
Ivoclar Vivadent, AG
Dental · 103d
Cleared Apr 04, 2017
BePOD Cannulated Arthrodesis Screws
K170040 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 89d
Cleared Apr 04, 2017
Acuson SC2000 Diagnostic Ultrasound System
K170315 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 62d
Cleared Apr 04, 2017
CD HORIZON™ Fenestrated Screw Set
K170347 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 60d
Cleared Apr 04, 2017
ER-REBOA Catheter
K170411 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 53d
Cleared Apr 04, 2017
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
K170560 · MQL
CooperSurgical, Inc.
Obstetrics & Gynecology · 36d
Cleared Apr 04, 2017
Beta-CrossLaps CalCheck 5
K170678 · JJX
Roche Diagnostics
Chemistry · 29d