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
28369–28392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2017
Ahmed Glaucoma Valve Model FP8
K171451 · KYF
New World Medical, Inc.
Ophthalmic · 83d
Cleared Aug 08, 2017
GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
K171707 · GEI
Gowoonsesang Cosmetics Co., Ltd.
General & Plastic Surgery · 61d
Cleared Aug 08, 2017
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
K171735 · PTI
C.R. Bard, Inc.
General Hospital · 57d
Cleared Aug 08, 2017
JAZZ Passer Band
K171881 · OWI
Implanet, S.A.
Orthopedic · 46d
Cleared Aug 08, 2017
Delta III Lithotripter
K172084 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 08, 2017
HS40 Diagnostic Ultrasound System
K172129 · IYN
Samsung Medison Co., Ltd.
Radiology · 25d
Cleared Aug 07, 2017
FuzeFix Screw System
K170038 · HWC
Fusion Orthopedics, LLC
Orthopedic · 214d
Cleared Aug 07, 2017
InMode Diolaze XL
K170738 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 150d
Cleared Aug 07, 2017
Anterior Spine Truss System (STS) Interbody Fusion Device
K170851 · MAX
4Web, Inc.
Orthopedic · 138d
Cleared Aug 07, 2017
Merit Syringe
K171362 · FMF
Merit Medical Systems, Inc.
General Hospital · 90d
Cleared Aug 07, 2017
dpl SpectraLite
K171386 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 88d
Cleared Aug 07, 2017
Epix Electrosurgical Probe with Smoke Evacuation
K171684 · GEI
Applied Medical Resources Corporation
General & Plastic Surgery · 61d
Cleared CT Aug 07, 2017
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook...
K171712 · DTK
William Cook Europe Aps
Cardiovascular · 59d
Cleared Aug 04, 2017
Glucommander
K152300 · NDC
Glytec, LLC
General Hospital · 721d
Cleared Aug 04, 2017
Nucleoss Tpure Implant System
K160850 · DZE
Sanlilar Tibbi Cihazlar Med....
Dental · 494d
Cleared Aug 04, 2017
Life Essence Universal Porcelain System
K163251 · EIH
Blue Sky Bio
Dental · 259d
Cleared Aug 04, 2017
Hi-Dow Wireless TENS/EMS System (Model HD-5N)
K163393 · NUH
Hi-Dow International, Inc.
Neurology · 245d
Cleared Aug 04, 2017
Premier
K170861 · NKB
Shandong Weigao Orthopaedic Device...
Orthopedic · 134d
Cleared Aug 04, 2017
REVEAL Bulk
K171147 · EBF
Bisco, Inc.
Dental · 107d
Cleared Aug 04, 2017
Cellvizio 100 Series Systems with Confocal Miniprobes
K171345 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 88d
Cleared Aug 04, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG...
K171366 · GZF
Stimwave Technologies Inc., Dba...
Neurology · 87d
Cleared Aug 04, 2017
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
K171596 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 65d
Cleared Aug 04, 2017
Maestro Microcatheter
K172081 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 25d
Cleared Aug 03, 2017
Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
K161358 · JCX
Surgical Instrument Service and...
General & Plastic Surgery · 444d