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
26617–26640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2018
OMNICHROMA
K173275 · EBF
Tokuyama Dental Corporation
Dental · 138d
Cleared Feb 27, 2018
ALTA Anterior Cervical Interbody Spacer
K173324 · ODP
Astura Medical
Orthopedic · 130d
Cleared Feb 27, 2018
Zygomatic Implant System
K173343 · DZE
Southern Implants (Pty), Ltd.
Dental · 126d
Cleared Feb 27, 2018
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS...
K173683 · PRI
DiaSorin, Inc.
Microbiology · 88d
Cleared Feb 27, 2018
Activmotion Range
K173746 · HRS
Newclip Technics
Orthopedic · 81d
Cleared Feb 27, 2018
Rezum System
K180237 · KNS
Nxthera, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 26, 2018
ENDOSEAL MTA
K170175 · KIF
Maruchi
Dental · 403d
Cleared Feb 26, 2018
OpClear System
K171637 · OCX
Cipher Surgical, Ltd.
Gastroenterology & Urology · 269d
Cleared Feb 26, 2018
Bluetooth blood pressure monitor
K171668 · DXN
Visiomed Group SA
Cardiovascular · 266d
Cleared Feb 26, 2018
TRYPTIK2 C-Plate Anterior Cervical Plate System
K171797 · KWQ
Spineart
Orthopedic · 255d
Cleared Feb 26, 2018
Neurostructures Cavetto® Cervical Cage System
K172320 · ODP
Neurostructures, Inc.
Orthopedic · 209d
Cleared Feb 26, 2018
Vygon PICCs
K172899 · LJS
Vygon USA
General Hospital · 157d
Cleared Feb 26, 2018
Stryker iVAS 13g Bone Biopsy Kit
K180327 · KNW
Stryker Corporation
Gastroenterology & Urology · 20d
Cleared Feb 24, 2018
Trilor Disks, Blocks and Arches
K173643 · EBF
Bioloren S.R.L.
Dental · 89d
Cleared Feb 23, 2018
DM-Density
K170540 · LLZ
Densitas, Inc.
Radiology · 365d
Cleared Feb 23, 2018
Ultraxx Nephrostomy Balloon Catheter
K171601 · LJE
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Feb 23, 2018
Prismaflex System 8.10
K171671 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 262d
Cleared Feb 23, 2018
Sutter CURIS RF Generator
K171869 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 246d
Cleared Feb 23, 2018
Axiostat Chitosan Hemostatic Dressing
K172324 · QSY
Advamedica, Inc.
General & Plastic Surgery · 206d
Cleared Feb 23, 2018
Cavetto-SA Cervical Cage System
K173077 · OVE
Neurostructures, Inc.
Orthopedic · 147d
Cleared Feb 23, 2018
SPIN-SWI
K173224 · LNH
Spintech, Inc.
Radiology · 143d
Cleared Feb 23, 2018
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use),...
K173303 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 128d
Cleared Feb 23, 2018
KLS Martin L1 MMF System
K173320 · JEY
KLS-Martin L.P.
Dental · 126d
Cleared Feb 23, 2018
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
K173468 · JAK
Toshibamedical Systems Corporation
Radiology · 107d