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
Titanium Interbody System
Spine Innovation, LLC
SmartPilot YpsoMate NS-A2.25
Ypsomed AG
CombiDiagnost R90
Philips Medical Systems Dmc GmbH
Pocket Ultrasound System
Guangdong Youkey Medical Co., Ltd.
Maestro Microcatheter
Merit Medical System, Inc.
Powder free nitrile examination glove- blue, non-sterile
Hong Seng Gloves Sdn Bhd
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Ki
Access Vascular, Inc.
Insulin Syringes without needle
Berpu Medical Technology Co., Ltd.
SAGI Cervical Cage System
ZheJiang Decans Medical Devices Co., Ltd.
VIOLA
Vascular Graft Solutions, Ltd.
Manual Wheelchair (SYIV100-CA9221)
Foshan Shunkangda Medical Tech Co., Ltd.
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Bl
Guangdong Kingfa Sci. & Tech.Co., Ltd.
ROVO Mechanical Thrombectomy Device
2mg, Inc.
Catalyst R1 Reverse Shoulder System
Catalyst Orthoscience, Inc.
eMVFit (MVF-10M)
Weero Co., Ltd.
OLIZ LTB-1000A
Ltbio Co., Ltd.
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra
Sonoscape Medical Corp.
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Jiangsu Synecoun Medical Technology Co., Ltd.
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Ortho-Clinical Diagnostics, Inc.
Optimas MAX System
InMode , Ltd.
PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
DePuy Mitek, Inc.
Target Detachable Coil
Stryker Neurovascular
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
Guangzhou Hehong Biotech Co., Ltd.
AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
Hangzhou AllTest Biotech Co., Ltd.
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Vascular Solutions, LLC
MEDRAD® Imaging Bulk Package Transfer Spike
Bayer Medical Care, Inc.
Venue Go
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
EK Digital Abutments
Hiossen, Inc.
RxSight Insertion Device
Rxsight, Inc.
Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
Clariance
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