FDA 510(k) clearances — page 109
clearances on record, most recent first.
Clearances — page 109
10,801–10,900 of 175,620- K230271 — ISOLIS Cryoprobe
- K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K200452 — Meril-Bonewax
- K222746 — Overjet Caries Assist
- K223192 — XT Stain/Glaze
- K223365 — RODIN Palette Naturalizing Kit
- K223581 — Solero Microwave Tissue Ablation (MTA) System and Accessories
- K223823 — Disposable Surgical Face Mask
- K223882 — Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
- K220644 — Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
- K230046 — Vinyl examination gloves
- K220212 — BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
- K221589 — Starly pad
- K222559 — BD BACTEC Myco/F Lytic Culture Vials
- K222591 — BD BACTEC Plus Aerobic/F Culture Vials
- K223076 — BD Texium Closed Male Luer
- K223236 — Medline Surgical Face Mask and Medline Procedural Face Mask
- K223323 — Blood Collection Needle (with/without Needle Holder)
- K223803 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- K230002 — Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
- K230206 — Entarik Feeding Tube System; Entarik Feeding Tube
- K230382 — 3 Series NeoLux
- K230461 — Quantra Hemostasis Analyzer
- K230474 — EVA5 Insufflator
- K230797 — SmartMTA Capsule
- K212121 — VHT-200 Wound Treatment System
- K212207 — Sterile Hypodermic Syringe for Single Use
- K212394 — Implant-One Multi-Unit Abutment
- K221585 — 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
- K221805 — AccurSound Electronic Stethoscope AS-101
- K222096 — Endo Ultrasonic Activator
- K222105 — RESPONSE 5.5/6.0 Cannulated Screw System
- K222151 — Sterilization Wrap
- K222332 — MeMed BV
- K222367 — SAVE GBR
- K222423 — Fixone All Suture Anchor
- K222620 — Sterilized Latex Surgical Gloves
- K222859 — 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)
- K223419 — Triever16 Curve
- K223441 — SpaceFlex Acetabular Cup
- K223488 — ClosureFast Endovenous Radiofrequency Ablation Catheter
- K223765 — ATEC Lateral Navigation Instruments
- K223895 — Disposable Medical Nitrile Examination Gloves
- K230482 — Swedge Pedicle Screw Fixation System
- K213362 — BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.