Search FDA 510(k) Database

6,768 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13273–13296 of 174,061
Cleared Jan 31, 2022
DIAPLUS Universal
K213401 · KLE
DiaDent Group International
Dental · 105d
Cleared Jan 31, 2022
SKR 3000
K213908 · MQB
Konica Minolta, Inc.
Radiology · 48d
Cleared Jan 31, 2022
8mm Monopolar Curved Scissors
K220023 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 26d
Cleared Jan 28, 2022
syngo.CT Brain Hemorrhage
K203260 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 449d
Cleared Jan 28, 2022
Platform treatment system
K203395 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 436d
Cleared Jan 28, 2022
Optiflow Oxygen Kit
K211096 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 290d
Cleared Jan 28, 2022
Surgical Masks
K212120 · FXX
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 205d
Cleared Jan 28, 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U,...
K212341 · DTZ
Qura S.R.L
Cardiovascular · 184d
Cleared Jan 28, 2022
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
K212533 · DZE
Institut Straumann AG
Dental · 170d
Cleared Jan 28, 2022
iHealth infrared Ear thermometer PT5
K212598 · FLL
Andon Health Co, Ltd.
General Hospital · 165d
Cleared Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
K212648 · JHX
Ortho-Clinical Diagnostics
Chemistry · 158d
Cleared Jan 28, 2022
SyntheCel Dura Repair
K212943 · GXQ
Synthes USA Products, LLC
Neurology · 135d
Cleared Jan 28, 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 127d
Cleared Jan 28, 2022
STEP-1 PumEtch
K213093 · KLE
Rounding Third, LLC
Dental · 126d
Cleared Jan 28, 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and...
K213142 · LZA
Shen Wei (Usa), Inc.
General Hospital · 123d
Cleared Jan 28, 2022
ShinEvac Smoke Evacuation Pencil
K213317 · GEI
Shining World Health Care Co., Ltd.
General & Plastic Surgery · 116d
Cleared Jan 28, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use With...
K213325 · LZC
Anhui Xinyisheng Medical Technology...
General Hospital · 115d
Cleared Jan 28, 2022
X-CUBE i8, X-CUBE i9
K213523 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 86d
Cleared Jan 28, 2022
QuikPass Catheter
K214106 · DQY
Traverse Vascular, Inc.
Cardiovascular · 30d
Cleared Jan 27, 2022
Omnipod 5 ACE Pump (Pod)
K203768 · QFG
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
Omnipod 5 SmartBolus Calculator
K203772 · QRX
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
SmartAdjust technology
K203774 · QJI
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models),...
K210360 · GWO
Osteonic Co., Ltd.
Neurology · 353d
Cleared Jan 27, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K211210 · FMF
Azur Medical Company, Inc.
General Hospital · 279d