FDA 510(k) clearances — page 90
clearances on record, most recent first.
Clearances — page 90
8,901–9,000 of 175,620- K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
- K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+
- K231899 — HAtetracell-C Titanium Cervical IBF System
- K232089 — SOZO Pro
- K232151 — Dynamic TiBase
- K232878 — TransLoc 3D
- K232903 — Legend X Platform
- K230104 — Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
- K230249 — Ikshana
- K230570 — Willow Generation 3 Breast Pump
- K231725 — Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
- K232020 — Iontophoresis Electrodes
- K232118 — ANDORATE® Valve Kit
- K232128 — Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
- K211676 — Motiva Flora SmoothSilk Tissue Expander
- K222143 — APIS (R), VERIS (TM)
- K223697 — MRI compatibility for existing BioHorizons dental implants and abutments
- K223863 — BONHAWA Respiratory Humidifier
- K230125 — Neuroblade System
- K230370 — SpotLight/SpotLight Duo (with DLIR option)
- K230440 — Xpert® Xpress CoV-2 plus
- K230495 — Serena Sleep Night Guard
- K230741 — Macro & Micro-Test HCG Pregnancy Test Midstream
- K231495 — The Evolve System with the Transform Applicator
- K231642 — Veuron-Brain-pAb3
- K231672 — S1
- K231744 — VyLink Spinal Screw System
- K232429 — Titan Dental Design
- K232437 — Paragon 8F Balloon Guide Catheter
- K232481 — RIGEL 3DR Anterior Cervical Corpectomy System
- K232504 — Calibrate CCX Interbody System
- K232822 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
- DEN200076 — ORi
- K222222 — Artemis, Artemis TPO, Artemis MX
- K230650 — Monopolar Electrode Surgical Instrument
- K230707 — Skypro, Surgical Gown 6021
- K230717 — Exactech® Vantage® Total Ankle System
- K231152 — Collagen Wound Dressing
- K231231 — MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
- K231475 — MONTAGE-QS Settable, Resorbable Bone Putty
- K231486 — Stable-L Standalone Lumbar Interbody System
- K231551 — Stethophone
- K231574 — Scenaria View 4.2
- K231708 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
- K231814 — ValvuloPro Valvuloplasty Balloon Catheter
- K232448 — FREEPRINT® splintmaster
- K232802 — TMINI Miniature Robotic System
- K232809 — Cross Vascular RF Generator and Footswitch (optional accessory)
- K232838 — Monkey RingsTM External Fixation System
- K232852 — Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
- K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty
- K222025 — G4Derm / G4Derm Plus Synthetic Wound Matrix
- K223126 — SurgiAid® Collagen Wound Dressing
- K230116 — Vital Spinal Fixation System
- K230148 — Vlab
- K230220 — NeuViz 128 Multi-Slice CT Scanner System
- K230618 — MegaGen Dental Implant Systems Portfolio - MR Conditional
- K230897 — Anterion
- K231050 — Arm Blood Pressure Monitor
- K232070 — Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
- K232090 — JO Coconut Hybrid Warming Personal Lubricant
- K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
- K232460 — Disposable electrosurgical pencil (MD1000)
- K232499 — IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
- K232574 — VASSALLO GT Crossing14
- K232578 — VASSALLO GT 018 G12; VASSALLO GT 018 G30
- K232981 — Synq Software Version 1.3
- K233233 — EMPHASYS Femoral Stems
- K223027 — NeuroTrigger Basic (NTB)
- K230130 — Micromate Navi+
- K230916 — WeSensor
- K230961 — Zeus Spinal System
- K231413 — IPD Dental Implant Abutments
- K231658 — VEOS Spinal Fixation System
- K232341 — CarboClear® Pedicle Screw System
- K232471 — Vy Spine VyLam Laminoplasty System
- K232775 — ID NOW Influenza A & B 2
- DEN220087 — Edison System
- K221777 — Disposable Sterile Syringe
- K223802 — accufit
- K223905 — Vivio® LVEDP System
- K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
- K230091 — THE Cover
- K230144 — Denti.AI Detect
- K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
- K230777 — Patient Examination Gloves
- K230853 — EARP Nerve Cuff Electrode
- K231300 — Nutricair Enteral Syringe with ENFit
- K231603 — Standard Staple-Line Reinforcement (SSLR23)
- K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom)
- K232044 — Invictus Robotic Navigation Instruments
- K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
- K232055 — Vial Adapter
- K232056 — IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
- K232173 — Ascend VBR System, Ascend NanoTec VBR System
- K232276 — Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
- K232407 — Cautery Protective Actuation System (CPAS)
- K232411 — JuggerKnot Soft Anchor OC
- K232480 — ProtekDuo Veno-Venous Cannula Sets
- K232492 — 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor
Data sourced from openFDA. This site is unofficial and independent of the FDA.