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
18697–18720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 11, 2020
Route 92 Medical 070 Access System
K203043 · QJP
Route 92 Medical, Inc.
Neurology · 36d
Cleared Nov 10, 2020
JTK Dental Implant System
K183044 · DZE
Jiangyin Jintech Biotech Co., Ltd.
Dental · 739d
Cleared Nov 10, 2020
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw...
K193214 · MBI
Biomet, Inc.
Orthopedic · 355d
Cleared Nov 10, 2020
VagiVital Aktivgel
K200098 · NUC
Peptonic Medical AB
Obstetrics & Gynecology · 299d
Cleared Nov 10, 2020
Multi-Drive Interference Screw System
K200428 · MBI
Nvision Biomedical Technologies, Inc.
Orthopedic · 263d
Cleared Nov 10, 2020
StimSite
K200886 · ETN
Allotrope Medical, Inc.
Obstetrics & Gynecology · 222d
Cleared Nov 10, 2020
SnapshotNIR
K201976 · MUD
Kent Imaging
General & Plastic Surgery · 117d
Cleared Nov 10, 2020
Nio Fusion 12MP (MDNC-12130)
K203106 · PGY
Barco N.V.
Radiology · 26d
Cleared Nov 09, 2020
BD PureHub Disinfecting Cap
K193190 · QBP
Becton, Dickinson and Company
General Hospital · 356d
Cleared Nov 09, 2020
Vantage PSI System
K193432 · OYK
3D Systems
Orthopedic · 335d
Cleared Nov 09, 2020
Concinnity Aligners
K200005 · NXC
Drake Precision Dental Laboratory, Inc.
Dental · 312d
Cleared Nov 09, 2020
Accula Strep A Test
K201269 · PGX
Mesa Biotech, Inc.
Microbiology · 181d
Cleared Nov 09, 2020
OGYILI TENS/NMES Stimulator
K201431 · GZJ
Gongguan Tutamen Metalwork Co., Ltd.
Neurology · 161d
Cleared Nov 09, 2020
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound...
K201990 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 115d
Cleared Nov 09, 2020
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu...
K202274 · GZB
Boston Scientific Neuromodulation
Neurology · 90d
Cleared Nov 09, 2020
iFuse Implant System - iFuse Navigation
K203110 · OLO
SI-BONE, Inc.
Orthopedic · 25d
Cleared Nov 09, 2020
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC...
K203128 · IYN
Olympus Medical Systems Corp.
Radiology · 21d
Cleared Nov 06, 2020
Medical RF
K192621 · GEI
Triworks Group Srl
General & Plastic Surgery · 410d
Cleared Nov 06, 2020
AI-Rad Companion Organs RT
K193562 · QKB
Siemens Medical Solutions USA, Inc.
Radiology · 319d
Cleared Nov 06, 2020
BioMin Restore Plus
K200077 · LBH
Dr. Collins, Inc.
Dental · 297d
Cleared Nov 06, 2020
Durex Penck Standard, Durex Penck XL
K200672 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 238d
Cleared Nov 06, 2020
Neuro.Al Algorithm
K200750 · LLZ
Terarecon,Inc.
Radiology · 228d
Cleared Nov 06, 2020
cobas u 701 microscopy analyzer
K200811 · LKM
Roche Diagnostics
Hematology · 224d
Cleared Nov 06, 2020
V-Print splint
K201091 · MQC
Voco GmbH
Dental · 197d