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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

Vial Adapter with Filter

Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Nitrile Patient Examination Gloves, Powder Free

Lalan Rubbers (Pvt), Ltd.

OSSIOfiber® Cannulated Trimmable Fixation Nail

OSSIO , Ltd.

XSense Cryoablation System with CryoProbes

IceCure Medical , Ltd.

TITAN 3-D Wedge System

Paragon 28, Inc.

TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)

TriMed, Inc.

Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)

Scivita Medical Technology Co., Ltd.

OSSDSIGN Cranial PSI

Ossdsign AB

Pectus Blu Support Bar System

Biomet Micofixation

Electric Breast Pump

Shantou Huihengqi Electronic Technology Co., Ltd.

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465

Covidien, LLC

Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula

Qura S.R.L

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)

Hunan Accurate Bio-Medical Technology Co., Ltd.

Montage-XT Settable Bone Putty

Orthocon, Inc.

CATS-L Tonometer™ Prism

Cats Tonometer, LLC

LeafPure-Echo (LM-LPNdA)

Shenzhen Leaflife Technology Co., Ltd.

Vapotherm Aerosol Adapter AAA-2

Vapotherm, Inc.

Hailie Sensor NF0107 & NF0108

Adherium (Nz), Ltd.

EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)

Medos International SARL

Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology

Nanovis, LLC

Diagnostic X-ray System

Nanjing Perlove Medical Equipment Co., Ltd.

ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

Olympus Medical Systems Corporation

Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System

Tyber Medical, LLC

SS Abutment System

Osstem Implant Co., Ltd.

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.

Diode Laser System GP900A8, Diode Laser System GP900Q8

Shenzhen Gsd Tech Co., Ltd.

ClearTip TBNA Type

Finemedix Co., Ltd.

Merlexi Craft Bariatric series of manual wheelchairs

Turbo Wheelchair Co., Inc.

Bioline Dental Implant System

Bioline Dental Implant Systems, Ltd.

Wearable Electric Breast Pump (YM-8803)

Guangdong Youmeng Electrical Technology Co., Ltd.

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