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
28489–28512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2017
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound...
K171645 · KGN
Strukmyer Medical
General & Plastic Surgery · 50d
Cleared Jul 25, 2017
HP PRO Positioning Device
K171734 · IYE
Orfit Industries NV
Radiology · 43d
Cleared Jul 25, 2017
TomoTherapy Treatment Delivery System with iDMS
K171837 · IYE
Accuray Incorporated
Radiology · 35d
Cleared Jul 25, 2017
Radiance V4
K171885 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 29d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 25, 2017
MagVita TMS Therapy System
K171967 · OBP
Tonica Elektronik A/S
Neurology · 25d
Cleared Jul 24, 2017
Custom Bars
K162633 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 306d
Cleared Jul 24, 2017
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
K162858 · LZC
Careplus (M) Sdn Bhd
General Hospital · 285d
Cleared Jul 24, 2017
YELLOW 560 Fluorescence Module
K162991 · IZI
Carl Zeiss Meditec, AG
Radiology · 270d
Cleared Jul 24, 2017
Infant Transport Mattress Warmer with Disc
K163295 · IMD
Rapid Aid Corp.
Physical Medicine · 244d
Cleared Jul 24, 2017
DRACO Locking Bone Screws
K163486 · KTT
Hnm Total Recon, LLC
Orthopedic · 224d
Cleared Jul 24, 2017
JAWS(TM) Nitinol Staple System
K170923 · JDR
Paragon 28
Orthopedic · 117d
Cleared Jul 24, 2017
ARIX Diaphysis System
K171285 · HRS
Jeil Medical Corporation
Orthopedic · 84d
Cleared Jul 24, 2017
MP LeFort I Plates
K171364 · JEY
Stryker
Dental · 76d
Cleared Jul 24, 2017
True Spinal Fixation System
K171559 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 55d
Cleared Jul 24, 2017
Rampart L Lumbar Interbody Fusion Device
K171724 · MAX
Spineology, Inc.
Orthopedic · 42d
Cleared Jul 24, 2017
Klassic HD® Hip System
K171962 · LPH
Total Joint Othopedics, Inc.
Orthopedic · 24d
Cleared Jul 22, 2017
VITEK MS
K162950 · PEX
bioMerieux, Inc.
Microbiology · 271d
Cleared Jul 21, 2017
Fujifilm Duodenoscope Model ED-530XT
K152257 · FDT
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 711d
Cleared Jul 21, 2017
Teco Creatinine Enzymatic Reagent Kit
K161527 · JFY
Teco Diagnostics, Inc.
Chemistry · 414d
Cleared Jul 21, 2017
Portable Slit Lamp Microscope
K162778 · HJO
Suzhou Kangjie Medical, Inc.
Ophthalmic · 294d
Cleared Jul 21, 2017
Vitrea View
K163232 · LLZ
Vital Images, Inc.
Radiology · 246d
Cleared Jul 21, 2017
Progreat
K170223 · DQO
Ashitaka Factory of Terumo Corporation
Cardiovascular · 177d
Cleared Jul 21, 2017
True Form Reshapable Guide Wire
K170532 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 149d