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
Disposable Surgical Gown UM-148
Unimax Medical Products Co., Ltd.
Tomey Cornea/Anterior Segment OCT (CASIA2)
Tomey Corporation
LAP-iX2N
Sejong Medical Co., Ltd.
Sunrise
Sunrise SA
Hugo RAS System
Covidien, LLC
Elecsys Folate III
Roche Diagnostics
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
Olympus Medical Systems Corporation
Disposable Endoscopic Injection Needles
Changzhou New Med Micro-Medtech Co., Ltd.
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
Kms Medical Technology Co., Ltd.
ID LIGHT CURE SYSTEM
Id Korea Co., Ltd.
AGILON XO Shoulder System
Implantcast GmbH
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
Ttk Healthcare Limited
Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
Innova Vision, Inc.
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
Shenzhen AOJ Medical Technology Co., Ltd.
Radial Jaw 4 Pulmonary Biopsy Forceps
Boston Scientific Corporation
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
Cefla S.C.
KLS Martin Drill-Free MMF Screw
KLS-Martin L.P.
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wi
Merit Medical Ireland, Ltd.
RenaPure Endotoxin Retentive Filter
Evoqua Water Technologies, LLC
JO Coconut Hybrid Cooling Personal Lubricant
CC Wellness, LLC
Zeolite Hemostatic Cotton
Hangzhou Zeo-Innov Life Technology Co., Ltd.
VITAL Tubing Sets for Hemodialysis
Vital Healthcare Sdn. Bhd.
Micro Catheter
Suzhou Zenith Vascular SciTech Limited
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
Infobionic, Inc.
APRO 70 Catheter and Alembic Aspiration Tubing
Alembic, LLC
TruAbutment DS; TruBase
Truabutment, Inc.
Breathing circuit bacterial/viral filter
Shaoxing Haitech Medical Products Co., Ltd.
Medline Orbis Chemo Surgical Gown
Medline Industries, LP
SIGNA Bolt
Ge Medical Systems, LLC
Elecsys proBNP II, Elecsys proBNP II STAT
Roche Diagnostics
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