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
23185–23208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2019
Ranfac Cartilage Biopsy Needle
K183146 · KNW
Ranfac Corporation
General & Plastic Surgery · 163d
Cleared Apr 25, 2019
Synapse Enterprise Viewer Version 1.0
K183248 · LLZ
Fujifilm Corporation
Radiology · 155d
Cleared Apr 25, 2019
PANAVIA SA Cement Universal
K183537 · EMA
Kuraray Noritake Dental, Inc.
Dental · 127d
Cleared Apr 25, 2019
Brainlab Elements Image Fusion Angio
K190042 · LLZ
Brainlab AG
Radiology · 106d
Cleared Apr 25, 2019
MasteRad MX30
K190601 · KPR
Medicatech USA
Radiology · 48d
Cleared Apr 25, 2019
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s...
K190771 · NQX
Cepheid
Microbiology · 30d
Cleared Apr 24, 2019
A&D Medical Blood Pressure Monitors
K173065 · DXN
A&D Company, Ltd.
Cardiovascular · 572d
Cleared Apr 24, 2019
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown...
K182172 · FYA
Medline Industries, Inc.
General Hospital · 257d
Cleared Apr 24, 2019
V-Laser
K183156 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 160d
Cleared Apr 24, 2019
Occlusion Balloon Catheter
K183679 · MJN
Qxmedical, LLC
Cardiovascular · 117d
Cleared Apr 24, 2019
Halley resin
K190043 · EBI
Dentsply Sirona
Dental · 105d
Cleared Apr 24, 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope,...
K190113 · HIH
Corinth Medtech, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 24, 2019
AXS Vecta Aspiration System
K190212 · NRY
Stryker Neurovascular
Neurology · 79d
Cleared Apr 24, 2019
Parcus ATLAS
K190375 · MBI
Parcus Medical, LLC
Orthopedic · 64d
Cleared Apr 24, 2019
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K190496 · OAS
Cefla S.C.
Radiology · 55d
Cleared Apr 24, 2019
IntelliCartTM System
K190789 · JCX
Dornoch Medical Systems
General & Plastic Surgery · 28d
Cleared Apr 24, 2019
RAYSCAN a-Expert3D
K190812 · OAS
Ray Co., Ltd.
Radiology · 26d
Cleared Apr 23, 2019
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
K181472 · FEB
Advanced Sterilization Products (Asp)
General Hospital · 323d
Cleared Apr 23, 2019
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
K181971 · FAD
Cook Incorporated
Gastroenterology & Urology · 273d
Cleared Apr 23, 2019
Reprocessed Supreme Diagnostic Electrophysiology Catheter
K182386 · DRF
Innovative Health, LLC
Cardiovascular · 231d
Cleared Apr 23, 2019
Flexible HD Cysto-Urethroscope System
K182723 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 207d
Cleared Apr 23, 2019
NanoBone SBX PUTTY, NanoBone QD
K190110 · MQV
Artoss GmbH
Orthopedic · 90d
Cleared Apr 23, 2019
Elcam Stopcocks and Manifolds
K190489 · FMG
Elcam Medical Acal
General Hospital · 54d
Cleared Apr 23, 2019
SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr...
K190621 · KNS
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 43d