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
Ball Joint Guide Array (66295)
Bayer Medical Care, Inc.
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ort
Stryker Leibinger GmbH & Co KG
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Tonica Elektronik A/S
VEINOPLUS Back
Dynapulse Medical
Dynamic TiBase; TRI Screws
Talladium España, SL
Shoreline ACS Interbody System; Shoreline RT Interbody System
SeaSpine Orthopedics Corporation
Opulent TiNbN Coated Knee
Meril Healthcare Pvt. , Ltd.
Fiber Laser Treatment Systems (HS-232,HS-233)
Shanghai Apolo Medical Technology Co., Ltd.
SurgiAid Collagen Wound Dressing (HA)
Maxigen Biotech, Inc.
Cannulated Screws
Maxxion Medical, LLC
ARTIS pheno (VE21) System
Siemens Medical Solutions USA, Inc.
Non-Sterile Ultrasound Transmission Gels
Hony Medical Co., Ltd.
Clearblue® Early Digital Pregnancy Test
Spd Swiss Precision Diagnostics GmbH
DESS Dental Smart Solutions
Terrats Medical SL
miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with Eautra
Benq Materials Corporation
Disposable Surgical Face Mask
Anhui Cleanpro Pharmpack Co., Ltd.
syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
TMINI Miniature Robotic System
THINK Surgical, Inc.
safety lancet
Tianjin Huahong Technology Co., Ltd.
RC-SwiftPrep
Belport Company, Inc., Gingi-Pak
More-Cell-System
Agency For Medical Innovations GmbH
CT3000Pro
Srs Medical
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
Dixi Medical
Nitrile Examination Gloves (Blue, Violet)
Lyncmed Medical Technology (Beijing) Co., Ltd.
Arm Type Blood Pressure Monitor (BPM82)
Avita Corporation
reVive Light Therapy® Wrinkle and Acne LED Device
Led Technologies, Inc.
SternaFuse Ti Fixation System
Fusion Innovations, LLC
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
The Magstim Company Limited
NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner
SeaSpine Orthopedics Corporation
ARIX Small Fragment System
Jeil Medical Corporation
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