Search FDA 510(k) Database

7,075 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
20209–20232 of 174,061
Cleared Sep 26, 2019
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip...
K190029 · GCJ
Changzhou Xin Neng Yuan Medical...
General & Plastic Surgery · 262d
Cleared Sep 26, 2019
SepaSperm Washing Solution, SepaSperm Solution
K190199 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 234d
Cleared Sep 26, 2019
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K190454 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 213d
Cleared Sep 26, 2019
PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors,...
K190466 · LZA
Shen Wei (Usa), Inc.
General Hospital · 212d
Cleared Sep 26, 2019
PRECICE System
K191336 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 132d
Cleared Sep 26, 2019
StoneChecker
K191530 · LLZ
Imaging Biometrics, LLC
Radiology · 108d
Cleared Sep 26, 2019
eCarbon IBDs
K191537 · ODP
Back 2 Basics Direct, LLC
Orthopedic · 108d
Cleared Sep 26, 2019
Exogenesis Hernia Mesh
K191545 · FTL
Exogenesis Corporation
General & Plastic Surgery · 107d
Cleared Sep 26, 2019
Genesys Spine Sacroiliac Joint Fusion System
K191748 · OUR
Genesys Spine
Orthopedic · 87d
Cleared Sep 26, 2019
Sterile Dilator
K192195 · DRE
Galt Medical Corp.
Cardiovascular · 44d
Cleared Sep 26, 2019
GXR-Series Diagnostic X-Ray System
K192364 · KPR
DRGEM Corporation
Radiology · 27d
Cleared Sep 26, 2019
BioZorb SP Marker
K192371 · NEU
Focal Therapeutics
General & Plastic Surgery · 27d
Cleared Sep 26, 2019
Spectralis HRA+OCT and Variants
K192391 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 23d
Cleared Sep 26, 2019
NuVasive NuvaLine
K192435 · LLZ
Nu Vasive, Incorporated
Radiology · 21d
Cleared Sep 25, 2019
NuStat
K183190 · POD
Beeken Biomedical, LLC
General & Plastic Surgery · 310d
Cleared Sep 25, 2019
3D Visualization System
K183675 · GCJ
Scivita Medical Technology Co., Ltd.
Obstetrics & Gynecology · 271d
Cleared Sep 25, 2019
LifeWindow LW8 Lite
K183687 · MWI
Digicare Biomedical Technology, Inc.
Cardiovascular · 271d
Cleared Sep 25, 2019
SafeBreath Filter Mouthpiece
K190022 · CAH
MD Diagnostics Limited
General Hospital · 264d
Cleared Sep 25, 2019
Aloe Glide Lubricant
K190323 · NUC
Desert Harvest, Inc.
Obstetrics & Gynecology · 224d
Cleared Sep 25, 2019
Mediracer NCS
K190536 · JXE
Mediracer OY
Neurology · 205d
Cleared Sep 25, 2019
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser...
K190875 · HQC
D.O.R.C. Dutch Ophthalmic Research...
Ophthalmic · 174d
Cleared Sep 25, 2019
ARIES MRSA Assay
K191742 · NQX
Luminex Corporation
Microbiology · 86d
Cleared Sep 25, 2019
OMNI TiN Coated Apex Knee™ System
K191765 · JWH
Omni Life Science, Inc.
Orthopedic · 86d
Cleared Sep 25, 2019
TranS1 Interbody Fusion System
K191791 · MAX
Trans1
Orthopedic · 84d