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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

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue

Guangdong Kingfa Sci. & Tech.Co., Ltd.

SENDERO MAX Delivery Catheter

Okami Medical, Inc.

Femoral Trochanteric Nail System – Neonail

Neoortho Produtos Ortopédicos S/A

Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

Siemens Healthcare Diagnostics, Inc.

EXPD 4343S

DRTECH Corporation

Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)

Taidoc Technology Corporation

Blood Volume Analyzer (200)

Daxor Corporation

NextAR™ Spine Platform

Medacta International S.A.

Ultrasonic Scaler Tips

Guilin Refine Medical Instrument Co., Ltd.

EARP Nerve Cuff Electrode

Nvision Biomedical Technologies, Inc.

Cypris eXact Suture Placement Device

Cypris Medical

eKuore Pro 4T - REF EP0098

Chip Ideas Electronics S.L.

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating

Waldemar Link GmbH & Co. KG

TaiChiB

Our United Corporation

SOLACE Sacroiliac Fixation System

Ht Medical, LLC Dba Xenix Medical

Silverlon Wound Contact, Burn Contact Dressings

Argentum Medical, Inc.

Wearable breast pump (model W8)

Shenzhen TPH Technology Co., Ltd.

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

Rocket Platinum Cured Cathter

Rocket Medical Plc

DigiLine Direct Print Aligner System

Park Dental Research Corporation

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

Sol-Millennium Medical, Inc.

Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Professional Latex Sdn Bhd

Starly pad

Shenzhen Xingyuanli Technology Co., Ltd.

Synthetic Bone Graft Particulate

Shenzhen Dazhou Medical Technology Co., Ltd.

INTEGRA Wound Matrix (Macro-Channels)

Integra LifeSciences Corporation

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w

Thermo Fisher Scientific

Gating Reflector Block

Varian Medical Systems, Inc.

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

Draegerwerk AG & CO Kgaa

Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291,

Shenzhen Ruiankang Technology Co., Ltd.

ProNephro AKI™ (NGAL)

Bioporto Diagnostic, Inc.

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