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
19657–19680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2020
Triathlon Total KneeSystem
K201343 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 51d
Cleared Jul 10, 2020
Resoundant Acoustic Driver System
K201389 · LNH
Resoundant, Inc.
Radiology · 44d
Cleared Jul 10, 2020
Eclipse Treatment Planning System v16.1
K201607 · MUJ
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Jul 10, 2020
DigitalDiagnost C50
K201725 · KPR
Philips Healthcare (Suzhou) Co., Lit.
Radiology · 17d
Cleared Jul 09, 2020
Optiflux Enexa F500 Dialyzer
K192928 · KDI
Fresenius Medical Care Reanal...
Gastroenterology & Urology · 266d
Cleared Jul 09, 2020
GC Temp Print
K193113 · EBG
GC America, Inc.
Dental · 240d
Cleared Jul 09, 2020
GTK Trocars
K193272 · GCJ
Guangzhou T.K Medical Instrument Co.,...
General & Plastic Surgery · 226d
Cleared Jul 09, 2020
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart,...
K200061 · NEY
Galil Medical, Inc.
General & Plastic Surgery · 178d
Cleared Jul 09, 2020
SR-8100 Portable X-ray Unit
K200637 · IZL
Shantou Institute of Ultrasonic...
Radiology · 121d
Cleared Jul 09, 2020
Zimmer, Inc. Hip Joint Prostheses MR Labeling I
K200823 · JDI
Zimmer, Inc.
Orthopedic · 101d
Cleared Jul 09, 2020
Rapid LVO
K200941 · QAS
Ischemaview, Inc.
Radiology · 92d
Cleared Jul 09, 2020
ETHICON Linx Esophagus Sizing Tool
K201035 · QJN
Torax Medical, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 09, 2020
i-Rapha Solution
K201296 · LLZ
Irm, Inc.
Radiology · 55d
Cleared Jul 09, 2020
XACT Robotic System
K201586 · JAK
Xact Robotics, Ltd.
Radiology · 28d
Cleared Jul 09, 2020
DuraDiagnost
K201640 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 23d
Cleared Jul 08, 2020
Dental Glass Ceramics Blocks
K192231 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 327d
Cleared Jul 08, 2020
Arthrex DynaNite Compression Plate
K193345 · HRS
Arthrex, Inc.
Orthopedic · 218d
Cleared Jul 08, 2020
B&J DVT Compression Devices MHH800/MHH800SQ
K200154 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 168d
Cleared Jul 08, 2020
Digital Thermometer
K200599 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 121d
Cleared Jul 08, 2020
Delta Multihole TT Pro Acetabular System
K200656 · LPH
Lima Corporate S.P.A.
Orthopedic · 118d
Cleared Jul 08, 2020
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
K200676 · EBG
Zirkonzahn Srl
Dental · 114d
Cleared Jul 08, 2020
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955 · DXZ
Vascutek, Ltd.
Cardiovascular · 90d
Cleared Jul 08, 2020
CAPERE Thrombectomy System
K201216 · QEW
Vascular Medcure, Inc.
Cardiovascular · 64d
Cleared Jul 08, 2020
VisCalor
K201307 · EBF
Voco GmbH
Dental · 54d