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
Lancing device
Tianjin Huahong Technology Co., Ltd.
FlashHeal 2 (FlashHeal 2.0)
Inwound Aps
VersaWrap
Alafair Biosciences, Inc.
prodisc® L Instruments
Centinel Spine, LLC
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)
Coloplast
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Bausch & Lomb, Incorporated
Albumin BCG2
Abbott Ireland Diagnostics Division
Peridot-EX Expandable Intervertebral Body Fusion System
Gbs Commonwealth Co., Ltd.
Procedure Mask, Surgical Mask
A Plus International, Inc.
Dreem 3S
Beacon Biosignals, Inc.
Adhese Universal DC, Cention Primer
Ivoclar Vivadent, AG
Respiratory Muscle Trainer
Chongqing Moffy Innovation Technology Co., Ltd.
SOLID CLIP Single Use Clip Applier
Medscope Biotech Co., Ltd.
Ceragem Automatic Thermal Massager (CGM MB-2401)
Ceragem Co., Ltd.
Fluido Compact System
The Surgical Company International B.V.
Frida Anterior Cervical Plate System
Spineup, Inc.
R2P Radifocus Glidewire Advantage
Terumo Corporation
B-Scan
Accutome, Inc. Doing Business AS Keeler USA
SeptAlign (SPLN001)
Spirair, Inc.
Aevumed PHANTOM Suture Anchors
Aevumed, Inc.
xvision Spine system
Augmedics, Ltd.
TearCare System
Sight Sciences, Inc.
Atlas Spine HiRISE Expandable Cervical Corpectomy System
Atlas Spine, Inc.
Remanufactured EndoWrist Cadiere Forceps (420049)
Rebotix
IPL hair removal machine
Shenzhen Borria Technology Co., Ltd.
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Sunray Medical Products, Inc.
Arthrex AlloSync PushLock Suture Anchor
Arthrex, Inc.
QuikClot Control+ Hemostatic Dressing
Z-Medica, LLC
AllTest Urinary Tract Infection Test
Hangzhou AllTest Biotech Co., Ltd.
Intensity Pulsed Light Therapy System
Beijing Adss Development Co., Ltd.
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