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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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