510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
HemoCare Hemodialysis System
Deka Research and Development
StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
Staclear, Inc.
Ziehm Solo FD
Ziehm Imaging GmbH
Hyper Insight - ICH
Sk, Inc.
Respiratory Gating for Scanners (2.1)
Varian Medical Systems, Inc.
Cystoscope System
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Edma Group, LLC
PICOANDY (Q-Switched Nd:YAG Laser)
Wontech Co., Ltd.
Fractional CO2 Laser Machine
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Servator P SALF Solution with THAM
S.A.L.F. Spa
c-med0 alpha
Cosinuss GmbH
Cardio P1
Bionet Co., Ltd.
Dental Implant Unit
Guilin Aesthedent Medical Instruments Co., Ltd.
UNITY Sacroiliac Joint Fixation System
Dio Medical Corporation
uWS-Angio Basic
Shanghai United Imaging Healthcare Co., Ltd.
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
Osteonic Co., Ltd.
YSI 2900C Biochemistry Analyzer
Ysi, Inc.
JETT PLASMA Medical II
Compex, Spol, S.R.O.
SOUNDSTAR CRYSTAL Ultrasound Catheter
Biosense Webster, Inc.
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
Task Force CORE
Cnsystems Medizintechnik GmbH
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
Artsmedia Denmark Aps
PacePro Wire
Opsens, Inc.
VASSALLO GT 018 Floppy
Filmecc Co., Ltd.
SmartGUIDE deflectable hydrophilic guidewire
Artiria Medical SA
AI-Rad Companion Organs RT
Siemens Healthcare GmbH
Neuromuscular Transmission Monitor TOF3D
MIPM Mammendorfer Institut für Physik und Medizin GmbH
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
Immunalysis Corporation
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
MacroLux Medical Technology Co., Ltd.
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Xiros, Ltd.
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