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
Vinyl Examination Gloves
Taian Hengchang Medical Technology Co., Ltd.
Anthogyr FlexiBase® titanium bases for Axiom® BL
Anthogyr
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with l
Medinice S.A.
IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
Boston Scientific
ClotTriever Thrombectomy System
Inari Medical, Inc.
F&P Optiflow+ Duet Nasal Cannula
Fisher & Paykel Healthcare, Ltd.
MR Contour DL
GE Healthcare
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Mono
Sofradim Production
Polyisoprene Surgical Gloves
Puyang Linshi Medical Supplies Co., Ltd.
NOABLE LASER
Daeju Meditech Engineering Co., Ltd.
EDS Calculus Softener TURBO CR
Essential Dental Systems, Inc.
iDart Lyme IgG ImmunoBlot Kit
Id-Fish Technology, Inc.
SoClean 3+
Soclean, Inc.
3MP Color LCD Monitor (CL-S301)
Jvckenwood Corporation
Sonendo Filling Material 5C
Sonendo, Inc.
ProGrip Self-Gripping Polypropylene Mesh
Covidien
Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
Total Joint Othopedics, Inc.
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
Owens & Minor (O&M) Halyard, Inc.
Kodiak Dual Port Coaxial Introducer Kit
Argon Medical Devices
Sagami Original 002 Polyurethane Male Condom
Mayer Laboratories
Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; G
Gymmax Technology Shenzhen Co., Ltd.
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
Fresenius Kabi AG
EONS Nitrile Examination Gloves Powder Free
Eons Gloves (Thailand) Co., Ltd.
JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus
Jdentalcare Srl
CLISIS SYSTEMS, Discovery RF180
General Medical Merate S.P.A
ADRx Admixture Device
Epic Medical Pte. , Ltd.
Nitrile Patient Examination Glove
Jiangxi Zhonghong Pulin Medical Products Co., Ltd.
KLS Martin Ixos System
KLS Martin L.P.
MagnetOs Flex Matrix
Kuros Biosciences B.V
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