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
21553–21576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2019
Pentax Medical Video Duodenoscope ED34-i10T2
K192245 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 15, 2019
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K192289 · JXG
Irras USA, Ltd.
Neurology · 84d
Cleared Nov 15, 2019
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
K192842 · GGM
Eurotrol B.V.
Hematology · 43d
Cleared Nov 15, 2019
CAPERE Thrombectomy System
K192935 · QEW
Vascular Medcure, Inc.
Cardiovascular · 29d
Cleared Nov 15, 2019
Soltus 500
K192936 · IZL
Sedecal., Sa.
Radiology · 28d
Cleared Nov 15, 2019
CoolTone
K192940 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 28d
Cleared Nov 14, 2019
EBA One Nailing System
K183666 · HSB
Citieffe S.R.L.
Orthopedic · 322d
Cleared Nov 14, 2019
Reprocessed ViewFlex™ Xtra ICE Catheter
K190478 · OWQ
Sterilmed, Inc.
Cardiovascular · 260d
Cleared Nov 14, 2019
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip...
K190522 · MQF
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 255d
Cleared Nov 14, 2019
LongBow Ti
K190721 · MAX
Life Spine, Inc.
Orthopedic · 239d
Cleared Nov 14, 2019
HeraBEAT™ US
K191110 · KNG
Heramed, Ltd.
Obstetrics & Gynecology · 202d
Cleared Nov 14, 2019
E-100 Electrosurgical Generator, SynchroSeal
K191280 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 185d
Cleared Nov 14, 2019
ST Internal Implant System
K192347 · DZE
Megagen Implant Co., Ltd.
Dental · 77d
Cleared Nov 14, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)...
K192355 · JWY
Beckman Coulter, Inc.
Microbiology · 77d
Cleared Nov 14, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
K192908 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Nov 14, 2019
Brainlab Compatible K2M Navigation Instruments
K192911 · OLO
K2m, Inc.
Orthopedic · 30d
Cleared Nov 13, 2019
EchoGo Core
K191171 · QIH
Ultromics, Ltd.
Radiology · 196d
Cleared Nov 13, 2019
AEON-C Stand Alone System
K191477 · OVE
Huvexel Co. , Ltd.
Orthopedic · 162d
Cleared Nov 13, 2019
Infrared Thermometer Model MD-H30
K191570 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 153d
Cleared Nov 13, 2019
Piper GO-IO Intraosseous Infusion System
K191976 · FMI
Piper Access, LLC
General Hospital · 112d
Cleared Nov 13, 2019
AMICUS Separator System
K192150 · LKN
Fresenius Kabi AG
Gastroenterology & Urology · 96d
Cleared Nov 13, 2019
Nox Sleep System
K192469 · OLZ
Nox Medical
Neurology · 65d
Cleared Nov 13, 2019
NuVasive CoRoent Small Interlock System
K192582 · OVE
Nu Vasive, Incorporated
Orthopedic · 55d
Cleared Nov 13, 2019
GMA 2.0 Pedicle Screw System
K192915 · NKB
Grafton Medical Alliance
Orthopedic · 29d