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
Vinyl Examination Gloves(Yellow)
Liuping Trading Co., Ltd.
4K UHD LCD Monitor OEV321UH
Olympus Medical Systems Corp.
Dornier Thulio
Dornier Medtech America, Inc.
Miro3D Wound Matrix
Reprise Biomedical, Inc.
Disposable Medical Face Mask
Xiantao Zhibo Nonwoven Products Co., Ltd.
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Var
Kettenbach GmbH & Co. KG
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
Kerecis Limited
Flow-Nail
Flow-Fx, LLC
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
Abbott Diabetes Care, Inc.
EZYPOR
Fci (France Chirurgie Instrumentation) Sas
S.I.N. Dental Implant System
S.I.N. Implant System Ltda
Retraxil
Kulzer, LLC
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Grand Work Plastic Products Co., Ltd.
Dark Star Deformity Pedicle Screw System
Republic Spine, LLC
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
Ambu A/S
Medifun Lancing Device, Model No. LD-E1
Medifun Corporation
VADER® Pedicle System, G21 Cement
Icotec AG
Flexx Junior (FLX-J00, FLX-J50)
Karma Mobility Co, Ltd.
SonoAir Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., Ltd.
Lavieen
Wontech Co., Ltd.
Pure Impact
Sofwave Medical, Ltd.
SNOO Smart Sleeper
Happiest Baby, Inc.
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pu
Qura S.R.L
Quantum Heater-Cooler
Spectrum Medical , Ltd.
SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
Siemens Medical Solutions USA, Inc.
3D Anatomic Models
Ricoh USA, Inc.
EVOS Pelvic and Acetabular System
Smith & Nephew
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
Steris Corparation
BostonSight® Specialty Lenses
Boston Foundation For Sight, Inc. D/B/A Bostonsight
RI.HIP MODELER
Blue Belt Technologies, Inc.
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