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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

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