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
25465–25488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2018
Syneron CO2RE System
K181523 · GEX
Syneron-Candela Corp
General & Plastic Surgery · 30d
Cleared Jul 11, 2018
16ch Foot/ Ankle SPEEDER
K181697 · MOS
Quality Electrodynamics, LLC
Radiology · 14d
Cleared Jul 10, 2018
Advanced Dental Applicance
K172991 · LRK
Dasoft Partners
Dental · 286d
Cleared Jul 10, 2018
TruMatch CMF Titanium 3D Printed Implant
K173039 · JEY
Materialise NV
Dental · 285d
Cleared Jul 10, 2018
Ceevra Reveal 2.0
K173274 · LLZ
Ceevra, Inc.
Radiology · 271d
Cleared Jul 10, 2018
3D Bolus Software
K180289 · MUJ
3D Bolus, Inc.
Radiology · 159d
Cleared Jul 10, 2018
Pseudo-Patient
K180697 · IYE
Rtsafe, Inc.
Radiology · 116d
Cleared Jul 10, 2018
LED Light Therapy Device
K180900 · OLP
Uvbiotek, LLC
General & Plastic Surgery · 95d
Cleared Jul 10, 2018
Disposable guides KDNG00
K180970 · ITX
Koelis
Radiology · 88d
Cleared Jul 10, 2018
Synermed ISE Reagents
K181201 · JGS
Infrared Laboratory Systems, LLC (Dba...
Chemistry · 64d
Cleared Jul 10, 2018
Zavation Cervical Plate System
K181244 · KWQ
Zavation Medical Products, LLC
Orthopedic · 61d
Cleared Jul 10, 2018
Zavation IBF System
K181246 · MAX
Zavation Medical Products, LLC
Orthopedic · 61d
Cleared Jul 10, 2018
Workflow Box
K181572 · QKB
Mirada Medical, Ltd.
Radiology · 26d
Cleared Jul 10, 2018
Uscan
K181574 · IYO
EchoNous, Inc.
Radiology · 25d
Cleared Jul 10, 2018
HardyDisk AST Plazomicin 30ug (PLZ30)
K181700 · JTN
Hardy Diagnostics
Microbiology · 13d
Cleared Jul 09, 2018
Straumann Jason Membrane
K173562 · NPL
Institut Straumann AG
Dental · 234d
Cleared Jul 09, 2018
Prime Acetabular Cup System
K180798 · LPH
Microport Orthopedics, Inc.
Orthopedic · 104d
Cleared Jul 09, 2018
Personal Lubricating Jelly
K180923 · NUC
Perrigo New York, Inc.
Obstetrics & Gynecology · 91d
Cleared Jul 09, 2018
EMPOWR VVC TIBIAL INSERT
K180930 · JWH
Encore Medical, L.P.
Orthopedic · 90d
Cleared Jul 09, 2018
Curiteva Cervical Interbody Fusion System
K181261 · ODP
Curiteva, LLC
Orthopedic · 59d
Cleared Jul 09, 2018
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video...
K181522 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 09, 2018
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
K181547 · IYO
Echosens
Radiology · 27d
Cleared Jul 08, 2018
BMLS16-1
K172971 · NUH
Biomedical Life Systems, Inc.
Neurology · 285d
Cleared Jul 08, 2018
PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with...
K173766 · LZC
Shen Wei (Usa), Inc.
General Hospital · 209d