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
ARIES Anterior Cervical Plate Systems
ZheJiang Decans Medical Devices Co., Ltd.
Remanufactured EndoWrist Long Tip Forceps (420048)
Rebotix
BNLE Hydrophilic Jacketed Peripheral Guidewire
Biomerics Nle
XC11 ICE System, USA
Yorlabs, Inc.
Biotres
Biotricity
BTI Interna Dental Implant System UnicCa - Prosthetic Components
B.T.I. Biotechnology Institute, Sl.
C350/C350G LCD Monitor; M550/M550G LCD Monitor
Nanjing Jusha Display Technology Co., Ltd.
Scan Monitor
Withings SA
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R
Samsung Medison Co., Ltd.
BriefCase-Triage
Aidoc Medical , Ltd.
Catalyft LS Expandable Interbody System
Medtronic Sofamor Danek USA, Inc.
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
Dongguan Lide Electric Appliance Co., Ltd.
Ureteral Access Sheath
Seplou (Zhuhai) Co., Ltd.
Oryx Cloud Imaging
Oryx Dental Software, Inc.
Passio Pump Drainage System
Bearpac Medical
Indigo® Aspiration System Aspiration Catheter 6X
Penumbra, Inc.
ArtiFascia
Nurami Medical , Ltd.
WSA Self-Fitting Hearing Aid Gen 2
Wsaud A/S
DCX Disposable Cassette (DCX)
Institut Geroges Lopez
CORGRIP* SR NG/NI Tube Retention System
Avanos Medical, Inc.
CARESCAPE R860
Datex-Ohmeda, Inc.
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc.
CoreLink Navigation Instruments
Corelink, LLC
PreXion3D Expedition
Prexion Corporation
MAGNETOM Avanto Fit
Siemens Medical Solutions USA, Inc.
R2P Navicross
Terumo Medical Corporation
RIGHTEST Blood Glucose Monitoring System Max Tel
Bionime Corporation
Disposable Surgical Gown
Shandong Zhushi Pharmaceutical Group Co., Ltd.
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
Li Medical Corporation , Ltd.
AquaA
Fresenius Medical Care Rental Therapies Group, LLC
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