FDA 510(k) clearances — page 110
clearances on record, most recent first.
Clearances — page 110
10,901–11,000 of 176,479- K231469 — PAXgene® Blood DNA Tube
- K231485 — iLet® ACE Pump
- K231489 — Sturdy Autoclave Super Microm
- K231533 — Habib EndoHPB
- K221024 — tremoflo C2 Airwave Oscillometry System
- K222998 — F3
- K223029 — Perfit CL
- K223103 — BethaLoc® stem cementless HA
- K223522 — NC° Thermometer (Gen 3), Model Number: NCTG3
- K223535 — SMARTbase Abutment System
- K230346 — Voluson SWIFT; Voluson SWIFT+
- K230781 — Belle Sensilube
- K230796 — Sparrow Ascent
- K230993 — CODA Anterior Cervical Plate System
- K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
- K231148 — ScleroSafe 150 mm, ScleroSafe 350 mm
- K231459 — HepaFatSmart (V2.0.0)
- K220072 — Sinobot X1
- K223917 — VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
- K223920 — VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
- DEN220048 — Neoasis
- K220107 — Mindray SV600 Ventilator, Mindray SV800 Ventilator
- K220703 — F&P 950 Respiratory Humidifier
- K220907 — The iNAP One Sleep Therapy System
- K221121 — Volumat Polyethylene I.V. Administration Set
- K222597 — BabySat 3
- K222906 — Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
- K222999 — Surgical Gown
- K223217 — Zynex Monitoring System, Model CM-1600
- K223357 — EyeArt v2.2.0
- K223556 — DeepCatch
- K223646 — IB Lab LAMA
- K223890 — NAJA Gastrointestinal Catheter
- K230015 — OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver
- K230421 — SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
- K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
- K230538 — All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
- K230894 — NuVasive Modulus ALIF System
- K230910 — NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
- K230965 — Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens
- K231045 — Healgen URS Test Strips
- K231110 — Manual Wheelchair (A006)
- K231136 — Fitness Belt (Model: KLT-07)
- K231199 — Solar Lumbar Interbody Fusion System
- K231461 — Smart Correction System (HA Half Pins)
- K222861 — EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
- K223258 — TNI Clear-Guard 3 angled breathing filter (1545020)
- K223469 — WallFlex Biliary RX Stent System
- K223715 — Celerity Incubator
- K223717 — Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
- K230386 — SpassageQ
- K230473 — IPL Hair Removal Device Models: MLY-T069
- K230718 — UTC 3mL Medication Cartridge
- K230762 — EDEN Spinal Fixation MIS System
- K231023 — ERBEJET® 2 System
- K231090 — Zevo Anterior Cervical Plate System
- K231109 — Xerxes Hip Stem
- K221540 — Synexis Sphere Rx
- K222144 — IR SLA Type Implant System
- K222790 — F65 Laser System
- K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
- K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
- K223291 — Electronic Blood Pressure Monitor
- K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
- K230731 — Zavation ALIF System
- K230761 — TRIGEN META-NAIL Nail System
- K231406 — ClearumTM HS
- K201153 — Tisuthes e-PTFE Surgical Patch
- K223517 — Clear Aligner
- K223518 — iOrtho
- K230112 — CAC Software
- K230567 — OptiVu ROSA® MxR
- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
- K231145 — Axis Anterior Cervical Plate System
- K213754 — SpiroHome Personal, SpiroHome Clinic
- K221888 — Genadyne Hybrid Foam Dressings
- K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil)
- K223669 — SecurePortIV Advanced Catheter Securement Adhesive
- K230397 — Cut Screw - Percutaneous Compression Screw
- K231022 — Pounce Thrombectomy System
- K231466 — RxSight Insertion Device
- K223361 — BMR 1900 PHISIO
- DEN220078 — Eroxon
- K220498 — NovoGen Wound Matrix
- K222450 — LVIS NeuroMatch
- K223091 — CT Perfusion V1.0
- K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
- K230293 — TheraFace Mask
- K230502 — Ear Pressure Relief Device(Model:ER813B)
- K230505 — Orthopantomograph OP 3D LX
- K230512 — Gamma4 System
- K230586 — Renuvion® Micro Handpiece
- K230709 — Auryon Atherectomy System
- K230728 — JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
- K230744 — Acumed Acutrak 3 Headless Compression Screw System
- K230768 — M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
- K230776 — Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
- K230779 — Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K230892 — Fixone Biocomposite Anchor
Data sourced from openFDA. This site is unofficial and independent of the FDA.