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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