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
Mako Total Knee Application
Mako Surgical Corp.
ViewFlex Eco Reprocessed ICE Catheter
ABBOTT MEDICAL
Lyric4 Hearing Aid
Sonova AG
VersaCross Connect Transseptal Dilator
Baylis Medical Company, Inc.
APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis
Clever Culture Systems
Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
Bone Solutions, Inc.
Telescope Guide Extension Catheter
Medtronic, Ireland
Byte Aligner System
Dentsply Sirona, Inc.
Tigon Medical Button System
Tigon Medical
Contour Shoulder
Quality Electrodynamics
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
Edan Instruments, Inc.
VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
Advin Biotech, Inc.
Dexcom G6 Continuous Glucose Monitoring (CGM) System
Dexcom, Inc.
Xpert® Xpress CoV-2 plus
Cepheid®
Pen Needle
Jiangsu Caina Medical Co.,Ltd
Arm Type Blood Pressure Monitor (BPM82)
Avita Corporation
Delta III Pro
Dornier Medtech America, Inc.
GEM ZIPCLIP
Synovis Micro Companies Alliance A Subsidiary of Baxter Int
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
Fingertip Pulse Oximeter
Zhuhai Linte Medical Instrument Co., Ltd.
Vy Spine ClariVy Cervical IBF System
Vy Spine, LLC
ADVIA Centaur® Total hCG assay
Siemens Healthcare Diagnostics, Inc.
SSS-NX (Serum Substitute Supplement-NX)
Fujifilm Irvine Scientific
MIS Angulated multi-unit abutments
Dentsply Sirona
Leltek Ultrasound Imaging System (Model: LU700 Series)
Leltek, Inc.
Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06
Shenzhen Ulike Smart Electronics Co., Ltd.
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
Mercator Medical (Thailand), Ltd.
X-FLO Fluid Management System
Thermedx, LLC
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Fixxsure Anterior Lumbar Plate and Screw System
Oak Tree Engineering, LLC
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