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
30145–30168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173 · JJX
Roche Diagnostics
Immunology · 162d
Cleared Jan 12, 2017
Tooth Shade Resin Material
K162323 · EBF
Liaoning Upcera Co., Ltd.
Dental · 146d
Cleared Jan 12, 2017
Contour Next EZ Blood Glucose Monitoring System
K162336 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 143d
Cleared Jan 12, 2017
Ostial Sprit Cannulae
K162500 · DWF
Spyder Medical
Cardiovascular · 127d
Cleared Jan 12, 2017
WellDoc BlueStar, WellDoc BlueStar Rx
K162532 · MRZ
Welldoc, Inc.
General Hospital · 125d
Cleared Jan 12, 2017
Ayers Rock Cervical interbody fusion system
K162694 · ODP
Spineway
Orthopedic · 107d
Cleared Jan 12, 2017
FREND Vitamin D Test System
K162754 · MRG
Nanoentek USA, Inc.
Chemistry · 104d
Cleared Jan 12, 2017
SpineGuard DSG Zavation Screw System
K162884 · HBG
Spineguard S.A.
Neurology · 90d
Cleared Jan 12, 2017
Exilis XP II
K163176 · PBX
BTL Industries, Inc.
General & Plastic Surgery · 59d
Cleared Jan 12, 2017
48CH Head Coil
K163205 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 58d
Cleared Jan 12, 2017
Lumipulse G LH Calibrators
K163521 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 12, 2017
EzDent-i
K163533 · LLZ
Ewoosoft Co., Ltd.
Radiology · 27d
Cleared Jan 12, 2017
Lumipulse G Prolactin
K163544 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 27d
Cleared Jan 12, 2017
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
K163635 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 21d
Cleared Jan 11, 2017
Lympha-Flow(LF1200)
K160178 · IRP
Daesung Maref Co., Ltd.
Physical Medicine · 350d
Cleared Jan 11, 2017
ENDOCAM Flex HD Camera System 5521
K161204 · FET
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 258d
Cleared Jan 11, 2017
Dentalis Bio Solution Implants
K161281 · DZE
Dentalis Bio Solution Implants, LLC
Dental · 250d
Cleared CT Jan 11, 2017
Mortara Surveyor Patient Monitor
K161517 · MHX
Mortara Instrument, Inc.
Cardiovascular · 223d
Cleared Jan 11, 2017
ConceptoMed Luer-Jack Slip 10ml
K162057 · FMF
Conceptomed AS
General Hospital · 169d
Cleared Jan 11, 2017
Desara TV, Desara Blue TV
K162201 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Jan 11, 2017
CERAMAGE UP
K162261 · EBF
Shofu Dental Corporation
Dental · 153d
Cleared Jan 11, 2017
U-IGNITE Bladeless Trocar
K162387 · GCJ
Tianjin Uwell Medical Device...
General & Plastic Surgery · 139d
Cleared Jan 11, 2017
Venus Velocity Diode Laser System
K162765 · GEX
Venus Concept , Ltd.
General & Plastic Surgery · 103d
Cleared Jan 11, 2017
InSeca ARC Stylus, Aerin Console
K162810 · GEI
Aerin Medical, Inc.
General & Plastic Surgery · 97d