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
da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
OsteoCoil Nitinol Compression System (Multiple Component PNs)
Flower Orthopedics Corporation Dba Conventus Flower Ortho
StimRouter Neuromodulation System
Bioness, Inc.
CellFX® System
Pulse Biosciences, Inc.
Wrinkle Treatment Device (JM1, JM2B)
Shenzhen Qianyu Technology Co., Ltd.
Novum IQ Syringe Pump
Baxter Healthcare Corporation
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
Church & Dwight Co., Inc.
Elos Accurate® Denture Fixation System
Elos Medtech Pinol A/S
NEOVEIL Staple Line Reinforcement
Gunze Limited
Gamma4 System
Stryker GmbH
Manual Wheelchair
Hebei Ruilangde Medical Equipment Technology Group Co., Ltd.
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
Shenzhen Ulike Smart Electronics Co., Ltd.
HEXIM Implant; Samwon General Abutments
P&A USA
GraftGun Universal Graft Delivery System (GDS)
SurGenTec, LLC
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
Biofire Diagnostics, LLC
Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D
Edwards Lifesciences
fMRI Hardware System
Nordicneurolab AS
Stealth AXiS Cranial clinical application
Medtronic Navigation, Inc.
UltraPrint-Dental Temp C&B UV
Guangzhou Heygears IMC., Inc.
Inspire HCR and HCR DUAL cardiotomy reservoirs
Sorin Group Italia S.R.L.
CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)
Comercializadora Brever
Swift Ray 1
Swift Medical, Inc.
Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
EVOLUTION® Tibial Cones
Microport Orthopedics, Inc.
Esperance 3+ Aspiration Catheter System
Wallaby Medical
gammaCore Sapphire
Electrocore, Inc.
ONLINE TDM Phenytoin - Free Phenytoin application
Roche Diagnostics
Thermeo System
Pro3Dure Medical GmbH
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
Qingdao Hisense Medical Equipment Co., Ltd.
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
Medynus, Inc.
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