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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