FDA 510(k) clearances — page 118
clearances on record, most recent first.
Clearances — page 118
11,701–11,800 of 176,479- K223765 — ATEC Lateral Navigation Instruments
- K223895 — Disposable Medical Nitrile Examination Gloves
- K230482 — Swedge Pedicle Screw Fixation System
- K213362 — BioFire Global Fever Special Pathogens Panel +1 more
- K220464 — Tigon Medical Gryphon Anchor Line
- K221402 — CEREC Tessera Abutment Block, CEREC Tessera Abutment System
- K222036 — MPXA-2000
- K223049 — CardioSTAT® ECG Test Solution
- K223086 — Ceribell Instant EEG Headcap
- K223593 — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
- K223824 — POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
- K223837 — SPIRA®-C Integrated Fixation System
- K223889 — Stativ® Knotted UHMWPE Suture Anchor
- K230142 — Epi-Stop Nasal Gel/epistaxis pack
- K230191 — Arise UHP Dilatation Catheter
- K230194 — HF Surgery Generator 400KHZ
- K230533 — Motive Electrode
- K230583 — Tryptik Ti
- K214070 — OviTex PRS (Long Term Resorbable)
- K220026 — Genomadix Cube CYP2C19 System
- K222617 — EasyTouch Lancing Device
- K222709 — Retraction, CWM-910T, APOLEX Tite
- K223490 — FlightPlan for Embolization
- K223672 — Instrument Case P1340904
- K223708 — Entasis 3D Dual-Lead Sacroiliac Implant System
- K223844 — Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
- K230054 — DSM Biomedical Calcium Phosphate Cement
- K230471 — LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface
- K230520 — Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
- K230561 — Syngo Carbon Space VA30A
- K220725 — HPR45i
- K221996 — P-Cure Proton Beam Therapy System
- K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil)
- K222417 — Shina Safety Needle
- K222828 — Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
- K223043 — The Integrity Spine Core System
- K223245 — Colibrí
- K223875 — MOBINEURO Alita Intraoperative MRI System
- K230163 — TENS and EMS Stimulation (OTC)
- K230174 — TENS and EMS Stimulation (OTC)
- K221808 — InterOss Collagen
- K221841 — EOlife®
- K220963 — Simplexa COVID-19 & Flu A/B Direct
- K221119 — RCRP Flex reagent cartridge
- K221544 — MagVenture TMS Atlas Neuro Navigation System
- K221758 — SMR Stemless Anatomic
- K221772 — NeuroRPM
- K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
- K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable
- K221965 — FemDx FalloView
- K222101 — Prism
- K223073 — Alio
- K223162 — Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
- K223418 — DeGen Impulse AM System
- K223443 — Viz AAA
- K223613 — InThrill Thrombectomy System
- K223666 — Ablacath Mapping Catheter
- K223878 — Aevumed RAPID Suture Anchors
- K230115 — Denture Base Resin
- K230141 — LOQTEQ® VA Elbow Plates 2.7/3.5 System
- K230435 — Arthrex 3.9 mm SwiveLock Anchor
- K230441 — EMPOWR Stem Extender, 50mm
- K220673 — Sterile Silver Alginate Wound Dressing
- K222619 — Ensmile
- K222813 — Nitrile Examination Gloves
- K222838 — iSyncBrain©-C
- K222839 — EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
- K223084 — MilkMate Breast Pump
- K223095 — Senhance Surgical System
- K223154 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- K223393 — Electric Wheelchair
- K223828 — BENCOX Delta Option Heads
- K230404 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
- K220122 — APEX 6
- K220234 — Precice Intramedullary Limb Lengthening System
- K221924 — Digital Routines
- K222983 — NeuroBlate Fusion-S Software V3.17
- K222991 — Air Compression Leg Massager (model: EMK-701)
- K223102 — Tegamen Nitrile Examination Gloves
- K223375 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
- K223381 — iExaminer System with Panoptic Plus
- K223760 — ECHELON LINEAR 60 mm Cutter (GLC60) +8 more
- K230124 — LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
- K212906 — HeartBuds Electronic Stethoscope
- K213247 — JETT PLASMA Medical II
- K223137 — Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
- K223279 — RT Elements (4.0)
- K223464 — Leg and Foot Air Wave Pressure Therapy Device
- K223609 — RevCore Thrombectomy Catheter.
- K223753 — Cervical Plate System
- K230019 — SofWave System
- K230145 — ONE-CUF
- K221352 — Surgical Face Mask
- K222775 — Aarhus Applicator Set
- K222954 — Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
- K223321 — Omnia Medical Coupler-C Anterior Cervical Plate
- K223350 — Remi Robotic Navigation System
- K222456 — High Protection Surgical Gown
- K213744 — Avoset Infusion Pump System
Data sourced from openFDA. This site is unofficial and independent of the FDA.