Search FDA 510(k) Database

6,923 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
17473–17496 of 174,061
Cleared Sep 02, 2020
ApolloVue S100 Image System
K201552 · NQQ
Apollo Medical Optics, Ltd.
General & Plastic Surgery · 84d
Cleared Sep 02, 2020
Arthrex Mesh Plates
K201677 · HRS
Arthrex, Inc.
Orthopedic · 75d
Cleared Sep 02, 2020
SmartHDM-510 System
K201765 · FIZ
Mesa Laboratories, Inc.
Gastroenterology & Urology · 65d
Cleared Sep 02, 2020
Aesculap PAS-Port Proximal Anastomosis System
K202124 · FZP
Aesculap, Inc.
General & Plastic Surgery · 33d
Cleared Sep 02, 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal...
K202169 · KFM
Qura S.R.L
Cardiovascular · 30d
Cleared Sep 02, 2020
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K202182 · NRY
Imperative Care, Inc.
Neurology · 29d
Cleared Sep 02, 2020
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
K202215 · QMI
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Sep 02, 2020
EPIQ Series Diagnostic Ultrasound Systems
K202216 · IYN
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Sep 01, 2020
Resolution 360™ ULTRA Clip
K193424 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 266d
Cleared Sep 01, 2020
VICTUS Femtosecond Laser Platform
K200724 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 166d
Cleared Sep 01, 2020
Patient Administration Set
K200916 · IYT
Cyclomedica Australia Pty, Ltd.
Radiology · 148d
Cleared Sep 01, 2020
Image1 S CCU, Image1 S 4U Camera Head
K201135 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 126d
Cleared Sep 01, 2020
CAPOGEN Laser Cap
K201854 · OAP
Nature, Inc.redible, Inc.
General & Plastic Surgery · 57d
Cleared Sep 01, 2020
Endoscope Reprocessor OER-Elite
K201920 · FEB
Olympus Medical Systems Corp.
General Hospital · 53d
Cleared Sep 01, 2020
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz...
K202160 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 29d
Cleared Aug 31, 2020
TrueTear Intranasal Tear Neurostimulator
K193589 · QBR
Allergan
Ophthalmic · 252d
Cleared Aug 31, 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K201052 · PPT
KLS-Martin L.P.
Neurology · 132d
Cleared Aug 31, 2020
CONFIDENCE Spinal Cement System
K201831 · NDN
Depuy Spine, Inc.
Orthopedic · 60d
Cleared Aug 31, 2020
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology
K202251 · NRY
Penumbra, Inc.
Neurology · 21d
Cleared Aug 30, 2020
LabPro Data Management System
K201405 · LON
Beckman Coulter, Inc.
Microbiology · 94d
Cleared Aug 29, 2020
Masimo O3 Regional Oximeter System
K201432 · MUD
Masimo Corporation
General & Plastic Surgery · 89d
Cleared Aug 28, 2020
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
K191041 · OAT
Gni Co., Ltd.
Dental · 497d
Cleared Aug 28, 2020
FitRelief TENS&EMS Wireless Device
K191938 · NGX
Heat IN A Click, LLC
Neurology · 406d
Cleared Aug 28, 2020
Hemostatic Xerogel Sponge
K192671 · QSY
Solaplus Biotech Co., Ltd.
General & Plastic Surgery · 337d