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
BrainSpec Core Software
Brainspec, Inc.
UpDoc
Updoc, Inc.
Viz RV/LV
Viz. Ai, Inc.
Clear Miracle
Ods Co., Ltd.
Tempo Tampon
Dong-A Pharmaceutical Co., Ltd.
SCARLET® AC-Ti
Spineart SA
Fibresolve (with PCCP)
Imvaria, Inc.
Medline UNITE® Medial Malleolus Peg Plate System
Medline Industries, LP
IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
Shenzhen Qianyu Technology Co., Ltd.
Dental Implants and Abutments
Ditron Dental, Ltd.
Gemini Medical Cage System
ZheJiang Decans Medical Devices Co., Ltd.
Trigon Trigon HA Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies
UltraGuideCTR® image guided soft tissue release system
Sonex Health
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
Philips Medizin Systeme Boeblingen GmbH
HeartKey® Rhythm
B-Secur Limited
Flowflex Plus COVID-19 + Flu A/B Home Test
ACON Laboratories, Inc.
Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Concentriq Dx
Proscia, Inc.
SchurSign Tissue Marker
Surgmark GmbH
Novum IQ Syringe Pump (40800BAXUS)
Baxter Healthcare Corporation
Biotres
Biotricity
KIDS Arterial Filters
Sorin Group Italia S.R.L.
MFG-05
Zimmer Medizinsysteme GmbH
Implanova
Dental Evolutions, Inc.
Disposable Surgical Mask
Heilongjiang Yinjia Medical Equipment Co., Ltd.
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate),
TriMed, Inc.
Skin Care Beauty Mask (Model: MJ-06)
Shenzhen Kaiyan Medical CO , Ltd.
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model
STERIS Corporation
PRORAD X-Ray Flat Panel Detector with DROC
Prognosys Medical Systems Private Limited
Infinity CentralStation Wide
Draeger Medical Systems, Inc.
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