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
CO2 Laser Machine (Lume)
Nanjing Bestview Laser S&T Co., Ltd.
Sterile Latex Powder Free Surgical Gloves
Protect Gloves Company Limited
Hypnos (369054-200)
Cadwell Industries, Inc.
uCT 780
Shanghai United Imaging Healthcare Co., Ltd.
Sophy Mini Monopressure Valve (SM1)
Sophysa
Leg Massager (Models:RP-ALM070H, RP-ALM071H)
Shenzhen Ruiyi Business Technology Co., Ltd.
Diagnostic X-ray System
Nanjing Perlove Medical Equipment Co., Ltd.
Omnipod 6 algorithm
Insulet Corporation
Steiking Packaging for Medical Devices
Wipak OY
Water Solubility Human Body Lubricant
Dongguan Yanxuan Biotechnology Co., Ltd.
IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Rem
Miley Technology (Hebei) Co., Ltd.
ellacor System with Micro-Coring Technology
Cytrellis Biosystems, Inc.
Apex Flex
Sprintray, Inc.
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
Wrp Asia Pacific Sdn. Bhd.
Dakota ALIF System
Precision Spine, Inc.
HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
Procept Biorobotics
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
Surgical Instrument Service and Savings, Inc.
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
Signature Orthopaedics Pty, Ltd.
Diode Laser Hair Removal System (RD-SLD600)
Shanghai Omni Laser Skinology Co., Ltd.
AlignRT Plus
Vision Rt, Ltd.
CoraForce Microcatheter, CoraFlex Microcatheter
Reflow Medical, Inc.
Elos Accurate Customized Abutment
Elos Medtech Pinol A/S
Apex Locator
Cefla S.C.
Cios Select (VA21) Image Intensifier
Siemens Medical Solutions USA, Inc.
NOBILCAM IMPAK Disc
Shandong Huge Dental Material Corporation
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked c
Access Vascular, Inc.
OptimMRI
Rebrain, Sas
AcQMap® High Resolution Imaging and Mapping System
Acutus Medical, Inc.
S.I.N. Instrument Kits
S.I.N. - Sistema DE Implante Nacional S.A.
Kodiak C Spinal Implant System
Met One Technologies, LLC
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert