Search FDA 510(k) Database

7,126 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
21193–21216 of 174,061
Cleared May 28, 2019
MectaLock PEEK Suture Anchor
K190474 · MBI
Medacta International S.A.
Orthopedic · 90d
Cleared May 28, 2019
IGNITE Bone Void Filler
K190482 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared May 28, 2019
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K190606 · LZA
Kossan International Sdn Bhd
General Hospital · 81d
Cleared May 28, 2019
Optilite IgM CSF Kit
K190686 · CFN
The Binding Site Group , Ltd.
Immunology · 71d
Cleared May 27, 2019
Surgical Face Mask
K182515 · FXX
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 257d
Cleared May 24, 2019
Conical Plus Implant System
K181157 · DZE
Osseofuse International, Inc.
Dental · 388d
Cleared May 24, 2019
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
K181979 · KOD
Teleflexmedical, Inc.
Gastroenterology & Urology · 303d
Cleared May 24, 2019
MobileLink Acetabular Cup System
K182321 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 270d
Cleared May 24, 2019
Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K182575 · LYZ
Jiangxi Jaysun Medcare Co., Ltd.
General Hospital · 247d
Cleared May 24, 2019
TruDiagnosis System
K183530 · ODW
Akonni Biosystems, Inc.
Toxicology · 156d
Cleared May 24, 2019
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator...
K190077 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 128d
Cleared May 24, 2019
InCore® Lapidus Sterile Kits
K190231 · HWC
Nextremity Solutions, Inc.
Orthopedic · 107d
Cleared May 24, 2019
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
K190282 · DTQ
Spectrum Medical , Ltd.
Cardiovascular · 102d
Cleared May 24, 2019
Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge,...
K190378 · KNW
Bioncise NV
Obstetrics & Gynecology · 94d
Cleared May 24, 2019
LightLas Pattern Scanning System - TruScan Pro
K190448 · HQF
Light-Med(Usa), Inc.
Ophthalmic · 88d
Cleared May 24, 2019
Soliton Acoustic Wave Device
K190542 · GEX
Soliton, Inc.
General & Plastic Surgery · 81d
Cleared May 24, 2019
Tria Firm Ureteral Stent
K190603 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 77d
Cleared May 24, 2019
Envision ultrasound pad and cover
K190802 · ITX
Civco Medical Solutions
Radiology · 56d
Cleared May 24, 2019
COMPLETE CONTROL System Gen2
K191083 · GXY
Coapt, LLC
Neurology · 30d
Cleared May 23, 2019
MaxCap Ped and MaxCap Neo
K182362 · CCK
Maxtec, LLC
Anesthesiology · 266d
Cleared May 23, 2019
IMPEDE-FX Embolization Plug
K182390 · KRD
Shape Memory Medical
Cardiovascular · 261d
Cleared May 23, 2019
Longterm NPWT Foam Dressing Kit
K182458 · OMP
Zhejiang Longterm Medical Technology...
General & Plastic Surgery · 255d
Cleared May 23, 2019
Upstream GoBack Crossing Catheter
K182937 · DQY
Upstream Peripheral Technologies, Ltd.
Cardiovascular · 213d
Cleared May 23, 2019
SYNMESH System
K183054 · MQP
Depuy Synthes Spine
Orthopedic · 202d