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
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse P
Wuhan United Imaging Healthcare Co.,Ltd
Alpha Dent Implants Dental Implants System
Alpha Dent Implants GmbH
SAGICO Spinal System
Sagico VA USA, LLC
Advanced Tissue Resection Device
Micro-Tech (Nanjing) Co., Ltd.
OIC Variable Angle Small Fragment Locking Plate System
Orthopaedic Implant Company
DuraGraft Vascular Conduit Solution
Marizyme
VXvue
Vieworks Co., Ltd.
Saans (F4-01-00-000-000)
Innaccel Technologies Private Limited
Current Health System
Current Health , Ltd.
RemeOs Screw LAG Solid
Bioretec, Ltd.
Avatar Medical Software V1
Avatar Medical
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
Healgen Scientific,, LLC
VariTrax Sternal CircumFixation System
Circumfix Solutions, Inc.
uMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd.
CO2 Laser Therapy System (Model: LFS-D9U)
Sanhe Lefis Electronics Co., Ltd.
Picosecond Laser System (Model PS10-A and PS10-B)
Beijing Adss Development Co., Ltd.
CoreLink Navigation Instruments
Corelink, LLC
Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (R
Centerline Biomedical, Inc.
APOLLO ADVANTAGE Nitrile Examination Gloves
Dell Corning Corporation
Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
Ormco Corporation
LC ChromeFlow
S&C Polymer Silicon- Und Composite Spezialitaten GmbH
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
Hearx SA (Pty) , Ltd.
JADE PLUS PTA Balloon Dilatation Catheter
OrbusNeich Medical (Shenzhen) Co., Ltd.
JAZZ Solo sensor
Jazz Imaging, LLC Dba Jazz Imaging
Disposable Dual Action Tissue Clip
Micro-Tech (Nanjing) Co., Ltd.
SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.
NaviCam ProScan
Ankon Technologies Co., Ltd.
Portare System (FA-001)
Grumpy Innovation, Inc.
Ion-L
SurGenTec, LLC
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-
Nanjing Devin Medical Technology Co., Ltd.
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