Search FDA 510(k) Database

6,990 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18577–18600 of 174,061
Cleared Apr 09, 2020
Nautilus Smart ECMO Module
K191935 · BYS
Mc3 Incorporated
Cardiovascular · 265d
Cleared Apr 09, 2020
Rejuvapen NXT
K192138 · QAI
Refine USA, LLC
General & Plastic Surgery · 245d
Cleared Apr 09, 2020
Unified Arrhythmia Diagnostic System PocketECG IV
K193104 · DSI
Medicalgorithmics S.A.
Cardiovascular · 153d
Cleared Apr 09, 2020
PreXion3D Explorer EX
K193329 · OAS
Prexion Corporation
Radiology · 129d
Cleared Apr 09, 2020
ClearCalc
K193640 · MUJ
Radformation, Inc.
Radiology · 104d
Cleared Apr 09, 2020
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus...
K200001 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 98d
Cleared Apr 09, 2020
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC...
K200052 · ODP
Orthofix, Inc.
Orthopedic · 90d
Cleared Apr 09, 2020
Powder Free Nitrile Examination Glove (Aqua Green)
K200326 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
K200492 · CHL
Abbott Point of Care, Inc.
Chemistry · 41d
Cleared Apr 09, 2020
Standard Trocar
K200517 · GCJ
Standard Bariatrics
General & Plastic Surgery · 38d
Cleared Apr 09, 2020
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with...
K200539 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 37d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External...
K200630 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Apr 09, 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
K200634 · DSP
Arrow International, Inc.
Cardiovascular · 30d
Cleared Apr 09, 2020
hyperion X5, NewTom GO, X-RADiUS COMPACT
K200688 · OAS
Cefla S.C.
Radiology · 24d
Cleared Apr 09, 2020
EchoNavigator
K200713 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 22d
Cleared Apr 08, 2020
Standard Bougie
K191885 · KNT
Standard Bariatrics
Gastroenterology & Urology · 268d
Cleared Apr 08, 2020
Panthera Dental Milled Bars
K192108 · NHA
Panthera Dental, Inc.
Dental · 247d
Cleared Apr 08, 2020
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable...
K192636 · FTL
Medtronic, Inc.
General & Plastic Surgery · 198d
Cleared Apr 08, 2020
AIMI-Triage CXR PTX
K193300 · QFM
Radlogics, Inc.
Radiology · 133d
Cleared Apr 08, 2020
Go2Wire Guide Wire
K193571 · DQX
Merit Medical System, Inc.
Cardiovascular · 107d
Cleared Apr 08, 2020
HI-TORQUE Steelcore Bare Guide Wire
K200144 · DQX
Abbott Vascular
Cardiovascular · 77d
Cleared Apr 08, 2020
Orfit Aerial Couchtop
K200282 · LHN
Orfit Industries NV
Radiology · 64d
Cleared Apr 08, 2020
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
K200411 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 49d
Cleared Apr 08, 2020
Flex Body Speeder
K200477 · MOS
Quality Electrodynamics, LLC
Radiology · 41d