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
AviClear Laser System
Cutera, Inc.
Bladeless Trocar Artemis Lap Cannula
T.A.G. Medical Products Corporation, Ltd.
Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Un
Boston Aesthetics, Inc.
Surgical mask
Jiangsu Xingtong Biotechnology Group Co., Ltd.
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEA
Olympus Corporations of the Americas
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
Surgical Instrument Service and Savings, Inc.
Electric Wheelchair (HG-630)
Zhejiang Automwheel Tech Co., Ltd.
Endeavor Stand-Alone Cervical IBF System
Innovasis
FIX-C PEEK Anterior Cervical Interbody System
Jeil Medical Corporation
Edwards MC3 Tricuspid annuloplasty ring (4900)
Edwards Lifesciences, LLC
DESS Dental Smart Solutions
Terrats Medical SL
Sterile Level 3 Surgical Gown
Barco Tekstil Sanayi VE Ticaret A.S.
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registra
Brainlab AG
CE Deliver (DLV)
CapsoVision, Inc.
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
Beckman Coulter, Inc.
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
L&K BIOMED Co., Ltd.
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
Joytech Healthcare Co. , Ltd.
Cionic Neural Sleeve NS-100
Cionic
Medical Surgical Mask
Nanchang Kanghua Health Materials Co., Ltd.
VitreJect® Needle; OcuSafe® Needle
Ocuject, LLC
Protrieve Sheath
Inari Medical
Remi Impression Material
Grindguard, Inc.
High Pressure Tubing
Ningbo Dizegens Medical Science Co.,Ltd
Qora Stool Management Kit
Cm Technologies, Inc.
GR Resin System MSI
Pro3Dure Medical
Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
Shenzhen Medke Technology Co., Ltd.
Disposable Blood Lancets
Suzhou Kyuan Medical Apparatus Co., Ltd.
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
Shenzhen Bsx Technology Electronics Co., Ltd.
Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
Beijing Konted Medical Technology Co.,Ltd
Vision 2, EVARVision, TrackVision 2, HeartVision 2
GE Medical Systems SCS
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