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
Xpert Wrist
Newclip Technics
LINQ II Insertable Cardiac Monitor (ICM)
Medtronic, Inc.
21HQ513D
Lg Electronics.Inc
Feeding Tube
Anhui Tiankang Medical Technology Co., Ltd.
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w
Thermo Fisher Scientific
DRPx Locking Distal Radius Plate System
Orthopaedic Implant Company
ATOMIC Nitinol Fixation System
Rmr Ortho, LLC
syngo Application Software
Siemens Medical Solutions USA, Inc.
14HQ721G-B
Lg Electronics.Inc
InVision 3T Recharge Operating Suite
Imris Imaging, Inc.
Atalante
Wandercraft SAS
Alio
Alio, Inc.
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
ViVi® Toga Premium
Thi Total Healthcare Innovation GmbH
Quantum Mitohormesis (QMT) (M2101)
Quantumtx Pte. , Ltd.
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
Olympus Medical Systems Corporation
EMPOWR Acetabular® Liner Extension
Encore Medical L.P.
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P
Cochlear
Cryopush Cold Compression Device (A02-P-001)
Chengdu Cryo-Push Medical Technology Co.,Ltd
neo315
Neoscan Solution GmbH
Custom-made Invisible Aligners
Zhejiang Yinchili Medical Technology Co., Ltd.
ROSA® Shoulder System
Orthosoft Inc (D/B/A Zimmer Cas)
Sonicaid Team3
Huntleigh Healthcare , Ltd.
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
Access Bio, Inc.
CO2 Laser Therapy System (Model: LFS-D9U)
Sanhe Lefis Electronics Co., Ltd.
uMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd.
8mm Monopolar Curved Scissors
Intuitive Surgical, Inc.
Bio-Medicus Life Support Catheter and Introducer
Medtronic, Inc.
CaRi-Plaque
Caristo Diagnostics , Ltd.
Flowflex COVID-19 Antigen Home Test
ACON Laboratories, Inc.
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