FDA 510(k) clearances — page 122
clearances on record, most recent first.
Clearances — page 122
12,101–12,200 of 176,479- K223678 — Sterile Syringes for Single Use
- K230063 — G Surgical Marksman Spinal Deformity System
- K230073 — Okti
- K230089 — ETHICON LINX® Esophagus Sizing Tool
- K221472 — Filter and HME/Filter
- K222247 — Hailie Sensor NF0110
- K222685 — NIRA Model 2
- K223038 — Access Cortisol
- K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
- K222451 — SAVE GBR
- K222928 — Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System
- K223146 — EVOLUTION SPINE Interbody System
- K223686 — Medical Protective Masks
- K212701 — Eminent Spine 3D Cervical Interbody Fusion System
- K221531 — ClotTriever Thrombectomy System
- K221980 — Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
- K222398 — Care Team Portal
- K222955 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
- K223169 — Nerivio
- K223296 — Videa Perio Assist
- K223444 — Powder Free Blue Nitrile Examination Glove
- K223735 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System
- K230095 — ScanX Swift 2.0, ScanX Swift View 2.0
- K230270 — 3M VitCal Liner/Base
- K222570 — COPAL knee moulds
- K222574 — Simparo Anchor Line Fixation System
- DEN220044 — Active Anthrax DetectTM Plus Rapid Test
- K213954 — BIOFIRE SPOTFIRE Respiratory (R) Panel
- K220296 — Manta Ray TDF Spacer
- K220337 — GaiaBone Bioabsorbable Bone Graft
- K220996 — Duoblade
- K221253 — SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
- K221348 — IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470)
- K221491 — Anivia SG1000 Pump Console
- K222063 — MONTAGE Settable, Resorbable Bone Putty
- K222153 — Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
- K222950 — AcuPebble OX100
- K223026 — NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
- K223051 — Pre-Formed Silicone Block
- K223395 — Luna Dental Implant System
- K223481 — VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
- K223648 — Cook® Spectrum® 2 MRC Central Venous Catheter
- K223679 — Access AMH
- K223876 — SMR Shoulder System
- K230051 — 14F iSLEEVE Introducer Set
- K230059 — Digital Flat Panel Detector
- K210751 — S.E.A.L. Hemostatic Wound Spray
- K213545 — Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
- K220126 — Geonic Nasal Aspirator, Geonic Nasal Cleaner
- K221356 — Wee Bell
- K221515 — StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
- K221781 — Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
- K222211 — Implant Direct Dental Implant Systems Portfolio - MR Conditional
- K222422 — Polaris Valve Electronic Reading Instrument
- K222671 — DeltaScan Patch
- K222680 — DeltaScan Monitor
- K222803 — Oncospace
- K223284 — SutureLoc Implant
- K223362 — Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
- K223406 — SmartRelease Endoscopic Soft Tissue Release System
- K223627 — PreView-III Anterior Cervical Plate System
- K230012 — Atomica Planner
- DEN220014 — RefleXion Medical Radiotherapy System (RMRS)
- K213480 — 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
- K221168 — Tinnitogram Signal Generator
- K221943 — EmbedMed
- K222751 — LED Light Therapy Device, KN-7000L
- K222863 — Garment Electrodes
- K222970 — LVivo IQS
- K223330 — Certas Plus Programmable Valves
- K223396 — Rapid RV/LV
- K230020 — BriefCase
- K221200 — XBody Go USA, XBody Pro USA
- K223117 — V-SPERM WASH
- K223351 — Naviswiss Knee
- K210112 — XChange Device, XChange System
- K221532 — PHMB Wound Dressing
- K222567 — Playground For All Love Sesh
- K223348 — My3D® Personalized Pelvic Reconstruction
- K212684 — BrainView QEEG Software
- K203833 — Tacrolimus Assay Kit
- K210166 — Omnispec ED1000
- K211559 — EasyStat 300
- K213059 — Tibia and Fibula System
- K220803 — VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
- K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- K221338 — F&P Airvo 3
- K221551 — FUJIFILM Endoscope Model EI-740D/S
- K221868 — QOCA image Smart CXR Image Processing System
- K222664 — Sim&Size
- K222835 — Prophecy Preoperative Navigation Alignment System
- K222901 — EVA15 insufflator
- K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
- K223090 — GEM Premier ChemSTAT
- K223254 — C2 Xplore
- K223546 — 14HQ721G-B
- K223903 — Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102) +3 more
- K223927 — 360CAS
- K220073 — RMF-2000
- K221424 — Sterile Surgical Powder Free Latex Glove
Data sourced from openFDA. This site is unofficial and independent of the FDA.