Search FDA 510(k) Database

7,021 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19105–19128 of 174,061
Cleared Feb 11, 2020
AcQMap High Resolution Imaging and Mapping System
K193013 · DQK
Acutus Medical, Inc.
Cardiovascular · 105d
Cleared Feb 11, 2020
EzRay Air Portable (Model: VEX-P300)
K200182 · EHD
VATECH Co., Ltd.
Radiology · 18d
Cleared Feb 10, 2020
K3Pro Konus New Abutments and Implants
K190192 · DZE
Argon Med. Productions Vertriebs...
Dental · 371d
Cleared Feb 10, 2020
Elos Accurate Hybrid Base
K191919 · NHA
Elos Medtech Pinol A/S
Dental · 207d
Cleared Feb 10, 2020
JO for Him H2O Gel Original Personal Lubricant
K192203 · NUC
United Consortium
Obstetrics & Gynecology · 180d
Cleared Feb 10, 2020
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy...
K192377 · IYE
Varian Medical Systems, Inc.
Radiology · 164d
Cleared Feb 10, 2020
Dermadry
K192749 · EGJ
Dermadry Laboratories, Inc.
Physical Medicine · 133d
Cleared Feb 10, 2020
InPen System
K192841 · NDC
Companion Medical, Inc.
General Hospital · 130d
Cleared Feb 10, 2020
Argen Clear Aligner, Argen Clear Aligner Premium
K192846 · NXC
Argen Corporation
Dental · 130d
Cleared Feb 10, 2020
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
K193156 · HWC
Arthrex, Inc.
Orthopedic · 88d
Cleared Feb 10, 2020
MectaFix CL Fixation Button with Continuous Loop
K193165 · MBI
Medacta International S.A.
Orthopedic · 87d
Cleared Feb 10, 2020
Sutter Swyng non-stick bipolar forceps, single-use
K193587 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 49d
Cleared Feb 10, 2020
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas...
K200065 · OCC
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared Feb 10, 2020
M.U.S.T. MINI Posterior Cervical Screws System
K200130 · NKG
Medacta International S.A.
Orthopedic · 20d
Cleared Feb 07, 2020
Pulmonary Cytology Brush
K182927 · BTG
Hobbs Medical, Inc.
Anesthesiology · 473d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · CGA
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · JGS
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Feb 07, 2020
Vesta RF Cannula
K190259 · GXI
Biomerics
Neurology · 365d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · JFL
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 07, 2020
Paragon XHD Diagnostic Ultrasound System
K191347 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 263d
Cleared Feb 07, 2020
Desara One Single Incision Sling System, 1 Pack
K191416 · PAH
Caldera Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Feb 07, 2020
Elefix V Paste for EEG & EMG
K191975 · GYB
Nihon Kohden Corporation
Neurology · 198d
Cleared Feb 07, 2020
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill...
K192273 · KLE
DiaDent Group International
Dental · 169d
Cleared Feb 07, 2020
Rochal Antimicrobial Wound Gel
K192527 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 147d