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
Patient Specific Planning Solution 3D Bone Models
Biomet Manufacturing Corp
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
Megine Industries Sdn Bhd
Veuron-Brain-pAb3
Heuron Co., Ltd.
Dr. pen Microneedling System
Guangzhou Ekai Electronic Technology Co., Ltd.
Talis EMR with Talis +ACG (Talis EMR with +ACG)
Talis Clinical, LLC
Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
Serpex Medical
TIDAL Fusion Cage System
Restor3D, Inc.
Disposable 4 Layers Surgical Face Mask
Social Medical Supply, LLC
JADE PLUS PTA Balloon Dilatation Catheter
OrbusNeich Medical (Shenzhen) Co., Ltd.
Stellar M22
Lumenis Be, Ltd.
Ni2 Implant System
Newton Implant Systems, Inc.
3DMatrix DynaFlex (DynaFlex)
Printbio, Inc.
Best Glove-Latex Powder Free Examination Glove
Bestsafe Glove Co., Ltd.
Bard® Mesh; Bard® Mesh Pre-Shaped
Davol, Inc.
ClotTriever XL Catheter (41-102)
Inari Medical, Inc.
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
Cepheid
Visionbody
Vb Technologies AG
SprintRay High Impact Denture Base
Sprintray, Inc.
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.
Powdered Free Sterile Natural Rubber Latex Surgical Gloves
The Egyptian Company For Medical & Electronic Industries
ConvaVAC Negative Pressure Wound Therapy System
Convatec Limited, Gdc Building
Control-IQ Technology
Tandem Diabetes Care, Inc.
Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs
Changzhou Universal Medical Equipment Co., Ltd.
CoolTone
Zimmer Medizinsysteme GmbH
TRAP EASY
H.S Hospital Service S.P.A
MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
IPL Hair Removal Device (Models: T31A, T32A)
Shenzhen Mlay Intelligent Technology Co., Ltd.
ORA Method LED Gua Sha (GS-04)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
Oxoid Limited (Part of Thermo Fisher Scientific)
CURASYS 2 (EMDN0003)
CG Bio Co., Ltd.
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