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
19777–19800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2020
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
K200975 · HGM
Huntleigh Healthcare Limited
Obstetrics & Gynecology · 72d
Cleared Jun 24, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K201462 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Jun 23, 2020
LVivo Software Application
K200232 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 145d
Cleared Jun 23, 2020
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera...
K200617 · FET
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 106d
Cleared Jun 23, 2020
ULab Systems uDesign Software
K200772 · PNN
Ulab Systems, Inc.
Dental · 90d
Cleared Jun 23, 2020
CUSA Clarity Ultrasonic Surgical Aspirator System
K200774 · LFL
Integra LifeSciences Corporation
Neurology · 90d
Cleared Jun 23, 2020
CO2mbiLED
K201096 · FCX
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 60d
Cleared Jun 23, 2020
VarseoSmile Crown plus
K201668 · EBF
Bego Bremer Goldschl?gerei Wilh....
Dental · 4d
Cleared Jun 22, 2020
Zeroveno
K192337 · JOW
Dimedi Co., Ltd.
Cardiovascular · 299d
Cleared Jun 22, 2020
Patient Monitoring Cable (SpO2 Extension Cable)
K192404 · DSA
Shenzhen Coreray Technology, Ltd.
Anesthesiology · 293d
Cleared Jun 22, 2020
Air Compression Therapy System
K192466 · IRP
Shenzhen Lifotronic Technology Co., Ltd.
Physical Medicine · 287d
Cleared Jun 22, 2020
Byteflies Kit
K192549 · OMC
Byteflies NV
Neurology · 279d
Cleared Jun 22, 2020
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
K200195 · OBJ
Northeast Scientific, Inc.
Cardiovascular · 147d
Cleared Jun 22, 2020
GlidePath 10F Long-Term Dialysis Catheter
K200627 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 104d
Cleared Jun 22, 2020
Opera Lebody (Gold), Opera Lebody (Zafiro)
K201107 · OHS
Gtg Wellness Co., Ltd.
General & Plastic Surgery · 59d
Cleared Jun 22, 2020
Axeos
K201140 · OAS
Dentsply Sirona
Radiology · 54d
Cleared Jun 22, 2020
O-Mec 690 Series Laparoscopes
K201151 · GCJ
Omec Medical, Inc.
General & Plastic Surgery · 54d
Cleared Jun 20, 2020
EverLift Submucosal Lifting Agent
K191923 · PLL
Gi Supply
Gastroenterology & Urology · 338d
Cleared Jun 20, 2020
InFrame™ Cannulated Fixation System
K201430 · HWC
Exsomed Corp.
Orthopedic · 19d
Cleared Jun 19, 2020
Fit & Brilliant Dental Implant System
K190637 · DZE
F&B Technology Co., Ltd.
Dental · 465d
Cleared Jun 19, 2020
TruAbutment DS
K191913 · NHA
Truabutment, Inc.
Dental · 338d
Cleared Jun 19, 2020
Cemented TSI Hip Stem
K192024 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 326d
Cleared Jun 19, 2020
STATClave G4 Chamber Autoclave
K192910 · FLE
Scican , Ltd.
General Hospital · 248d
Cleared Jun 19, 2020
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs...
K192954 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 242d