510(k) Device Clearances

ElastiMed SACS

Elastimed , Ltd.

Disposable Surgical Mask (Model: YYKZ-01)

Jiaxing Amazing Travel-Ware Co., Ltd.

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization

Shinva Ande Healthcare Apparatus Co., Ltd.

Disposable Subdermal Needle Electrode, Corkscrew

Technomed Europe

BosCATH Support Catheter

Sonorous NV, Inc.

LMA Fastrach ETT SU

Teleflex Medical

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable

Acuity Polymers, Inc.

Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)

Well-Life Healthcare Limited

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

Assure Tech., LLC

Air Compression Massager (Model LF-FT003)

Wenzhou Lingfeng Electronic Technology Co., Ltd.

EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 Syste

Intuitive Surgical, Inc.

BrainsWay Deep TMS System

Brainsway , Ltd.

Surgical Trays

Dentsply Sirona, Inc.

LumiVy™ Lumbar IBF System

Vy Spine, LLC

Medline Digital Thermometer Non-Lubricated Probe Sheath

Medline Industries, Inc.

Disposable Endoscopy Valve Set

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

Remanufactured EndoWrist Cadiere Forceps (420049)

Rebotix

OsteoSight™ Hip (v1)

Naitive Technologies, Ltd.

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

Ortho Clinical Diagnostics

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

W.A. Rubbermate Co., Ltd.

NObreath®

Bedfont Scientific, Ltd.

CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)

The Beauty Tech Group, Ltd.

OpenSensorX Series

Dentimax, Inc.

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)

Ambu A/S

Reusable Temperature Probe, Disposable Temperature Probe

Shenzhen Sino-K Medical Technology Co.,Ltd

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

Drägerwerk AG Co. Kgaa

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

Esaote, S.p.A.

Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021

Shenzhen Root Innovation Technology Co., Ltd.

FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000

Fujifilm Corporation

EARP Nerve Cuff Electrode

Retropsoas Technologies, LLC