FDA 510(k) clearances — page 76
clearances on record, most recent first.
Clearances — page 76
7,501–7,600 of 175,620- K231793 — RODIN 3D Resin SPLINT, Hard/Flex
- K231984 — Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
- K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
- K233069 — Removal System Large Bore 60 cc Syringe
- K233151 — PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
- K233611 — SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
- K233650 — SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
- K233733 — SyMRI
- K240594 — Grappler Suture Anchor R3FLEX IOL System
- K231986 — Modus IR
- K232268 — STERI-OSS Implant System
- K233167 — LW Implant System Abutment
- K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
- K233919 — VariAx 2 Distal Radius System
- K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
- K234085 — LUNE PureHygiene
- K240292 — Transcutaneous Electrical Nerve Stimulator (9029SCM)
- K240329 — Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)
- K240589 — Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
- K240620 — Cube Navigator
- DEN230034 — X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
- K231795 — QuickVue COVID-19 Test
- K231806 — Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
- K231926 — NeuroStar Advanced Therapy System (All previously cleared models)
- K231927 — Elecsys PTH , Elecsys PTH STAT
- K231930 — Digital Ultrasonic Diagnostic Imaging System (Model: F6)
- K231938 — Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
- K231953 — Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
- K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
- K232169 — FITBONE® Transport and Lengthening System
- K232282 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
- K232322 — MAGNETOM Terra; MAGNETOM Terra.X
- K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
- K232431 — syngo.CT Brain Hemorrhage
- K232548 — Corsano CardioWatch 287-2 System
- K232920 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
- K233148 — Augment Off-Axis Instrument System
- K233262 — Dukal SMS Sterilization Wrap
- K233441 — The Vest APX System (PVAPX1)
- K233569 — SeptAlign
- K233578 — BAHADIR STERILIZATION CONTAINERS
- K233713 — Pilling Tracheostomy Tubes
- K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- K240522 — Esophageal TTS Stent
- K240540 — uMR Omega
- K240690 — STRUXXURE® MCS Anterior Cervical Plate System
- K240715 — Idys® C ZP 3DTi
- K230088 — Ankle Truss System (ATS)
- K232439 — Electrical Stimulator System
- K232568 — IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
- K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
- K233753 — AI-Rad Companion (Pulmonary)
- K233926 — accufit
- K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
- K234006 — AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
- K234062 — APTUS Hand Scaphoid Plates
- K234081 — RedDrop ONE (One)
- K240122 — Normatec Elite
- K240179 — Medical Diode Laser (Model: L2)
- K240253 — Reach Needle
- K240309 — Tandem Mobi insulin pump with interoperable technology
- K240530 — DynaNail Mini Tapered Hybrid
- K240754 — N2
- K231974 — PATHFAST®hs-cTnI-II
- K232125 — V-PVP
- K232654 — Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
- K233002 — BEED 2,5, BEED 3,8
- K233375 — Tranquil-L Interbody System
- K233642 — InMode RF System
- K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
- K234047 — Automatic Registration
- K234049 — Straumann® BLC and TLC Implants - Line extension
- K234052 — Access Ferritin
- K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
- K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O
- K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
- K240507 — NuVasive AttraX Scaffold
- K240537 — SMARTXIDE PRO
- K240574 — BruxZir® Radiant
- K240743 — Peak Universal Bond
- K231719 — Medical Surgical Mask
- K231843 — ARX Viral Transport Media Collection and Transport System
- K232619 — MATRIX HA PEEK Cervical IBF System
- K232682 — Pre-Sintered Zirconia Coloring Liquid
- K233146 — Blood Pressure Monitor
- K233772 — Disposable Dual Action Tissue Closure Device
- K234024 — HWJECT Auto-disable syringe
- K240668 — Amydi-med Disposable Non-invasive EEG electrodes
- K233599 — X-Clever (ASHK100G)
- K233660 — nCommand Lite System
- K240113 — CORIOGRAPH Knee Pre-Op Plan
- K240139 — Real Intelligence CORI
- K240515 — uNion® MAX Cervical Plate System
- K230981 — Meriglu Topical Skin Adhesive
- K230802 — Xprecia Prime Coagulation System
- K231856 — TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
- K232234 — Nouvo Safety Set
- K232327 — Endorail
- K233307 — Intensity Pulsed Light Therapy System
- K233342 — CINA-ASPECTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.