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
SILKRO
Hironic Co., Ltd.
K-ASSAY CRP (Ver.2)
Kamiya Biomedical Company, LLC
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
Inner Mongolia Cureguard Medical Technology Co., Ltd.
Konig Mogen Clamp
Medline Industries, Inc.
Hearing Aid Feature (HAF)
Apple, Inc.
Fastplex BCR-ABL (p210) %IS digital PCR Kit
Suzhou Precigenome, Ltd. Co;
MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System
Smith & Nephew, Inc.
VYBE RF Electrosurgical System
ShenB Co., Ltd.
Hi bebe super (BT-150B)
Bistos Co., Ltd.
EveryWare
Breas Medical AB
Arthrex FiberTak Suture Anchor
Arthrex, Inc.
ViewFlex X ICE Catheter, Sensor Enabled
ABBOTT MEDICAL
AMT G-Tube Balloon Gastrostomy Feeding Device
Applied Medical Technology, Inc.
EdgePro
Biolase, Inc.
VM-2000
Ventis Medical, Inc.
Surgical Face Mask (Non-sterile)
Hubei Kimsoul Industrial Co., Ltd.
Pentax Medical Valve Set
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
contact forte Alpha
Bhm-Tech Produktionsgesellschaft Mbh
powder free nitrile examination glove - white, non-sterile
Hong Seng Gloves Sdn Bhd
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
Univlabs Technologies Private Limited
Philips IntelliSite Pathology Solution 5.1
Philips Medical Systems Nederland B.V.
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
Siemens Medical Solutions USA, Inc.
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc
Zoll Circulation, Inc.
Kinos Total Ankle System
Restor3D
Enivo
Aroa Biosurgery , Ltd.
Sonosite LX Ultrasound System
FUJIFILM Sonosite, Inc.
Double Tube Herbst Appliance
The Tmj Clinic PC
Saige-Dx
DeepHealth, Inc.
Maxiocel Chitosan Wound Dressing
Advamedica, Inc.
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