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
Diode laser hair removal machine (QDTM-02)
Beijing Nubway S&T Co., Ltd.
Electric Scooter (Mojo-T330)
Dongguan Smarfody Mobility Technology Co., Ltd.
Assisted Reproduction Laser System (Model ILS-400M)
Hua Yue Medical Technology Co., Ltd.
Ready to use Nelaton Catheter
Jamjoom Fullcare Corporation
SOLIUS PRO UVB Light Panel
Solius Labs, Inc.
Wellead Ureteral Catheter
Well Lead Medical Co., Ltd.
AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
Telemetry Monitor 5500 Release 4.0 (867232)
Philips Medizin Systeme Böblingen GmbH
OsteoCentric Dental Implant System
OsteoCentric Technologies
SIGNA Bolt
Ge Medical Systems, LLC
Quantra QStat Cartridge
Hemosonics, LLC
F&P Airvo 3 NIV (PT311US)
Fisher & Paykel Healthcare, Ltd.
Profoject Enteral Feeding Syringe
CMT Health PTE., Ltd.
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
Sanhe Laserconn Tech Co., Ltd.
CardiaMend Pericardial and Epicardial Reconstruction Matrix
Helios Cardio, Inc.
SOFIA 88 Catheter
MicroVention, Inc.
T-FIT
Techwin Co., Ltd.
CorVision® (91-205-Z0014)
CorVent® Medical, Inc.
Celerity 20 HP Biological Indicator
STERIS Corporation
ProMIS Extension Rod System
Premia Spine, Ltd.
Boehringer Laboratories Liver Retractor
Boehringer Laboratories, LLC
Iconic Nitrile Glove
Iconic Medicare Sdn Bhd
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrat
Ever Global (Vietnam) Enterprise Corporation
Digital Radiography CXDI-Elite, Digital Radiography E1
Canon, Inc.
Cove Putty, OsteoCove Putty
SeaSpine Orthopedics Corporation
BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232);
Becton Dickinson
ATTUNE® Revision Cones
Depuy Ireland UC
Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
Wontech Co., Ltd.
Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
Zeus Scientific
Alinity m BKV
Abbott Molecular, Inc.
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