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
Diagnostic X-ray System/PLX5200A
Nanjing Perlove Medical Equipment Co., Ltd.
Disposable Medical Face Mask
Zhejiang the Purples Protective Products Co.,Ltd
Sterile Hypodermic Needles for Single Use
Wepon Medical Technology Co., Ltd.
Disposable Safety Lancet
Beijing Ruicheng Medical Supplies Co., Ltd.
Peak Universal Bond
Ultradent Products, Inc.
Infusion Sets for Single Use
Sichuan Prius Biotechnology Co., Ltd.
NeuroSwift Pro
Neurobit Technologies Co., Ltd.
UniPrime A, UniPrime E, UniPrime E/C
S&C Polymer Silicon- Und Composite Spezialitäten GmbH
DEKA PHYSIQ 360
El.En S.P.A.
Prana System
Prana Surgical
ALLONUS Tech Prosthetics
Allonus Tech Co., Ltd.
Comby EEG Caps
Pamel D.O.O
OsteoCentric Technologies Cannulated Fasteners and Nuts
OsteoCentric Technologies
ExcelsiusXR
Globus Medical, Inc.
Elecsys HSV-1 IgG (08948844160)
Roche Diagnostics
Amplatzer Piccolo Delivery System (9-PDS-04F-045)
ABBOTT MEDICAL
PicoLO Premium
Laseroptek Co., Ltd.
Adin Long Dental Implant System
Adin Dental Implant Systems , Ltd.
SofWave System
Sofwave Medical, Ltd.
Arterys MICA
Arterys, Inc.
Cryojet Plus (SHE-ACP001-1)
Beijing Sano Laser S&T Development Co.,Ltd
Reprocessed Agilis NxT Steerable Introducer
Innovative Health, LLC
VERIQA RT EPID 3D
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
POTENZA
Jeisys Medical, Inc.
Aptima Neisseria gonorrhoeae Assay
Hologic, Inc.
Formus Hip
Formus Labs, Ltd.
Velacur One (LI-1100)
Sonic Incytes Medical Corp
ANDI 2.0
Imeka Solutions, Inc.
Microdent Sterilization Cassette
Implant Microdent System S.L.U.
Sonu
Sound Health Systems, Inc.
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