FDA 510(k) clearances — page 234
clearances on record, most recent first.
Clearances — page 234
23,301–23,400 of 175,699- K173418 — NobelParallel Conical Connection
- K182578 — Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
- K182641 — Sensus IORT System
- K182665 — Sensus TPS Workstation
- K183255 — Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
- K183279 — HEALIX Ti ANCHOR with DYNACORD
- K190105 — ZOOM Aspiration Pump
- K190255 — Sensus Healthcare TVM Balloon Applicator
- K180953 — AnyCheck IMT-100
- K181989 — MRIdian Linac System
- K183415 — VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)
- K180346 — Byte Aligner System
- K181409 — Pressure Therapy System PT1003
- K181872 — MIS Bunion System
- K183055 — Vector Hammertoe Correction System
- K183241 — BrainScope TBI (Model: Ahead 400)
- K183594 — Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J
- K182768 — TMS-Cobot TS MV
- K180509 — Quo-Test A1c System
- K181163 — Wu's Powered Wheelchair
- K181362 — TEMA Elbow System
- K183546 — GEM Premier ChemSTAT
- K183549 — GEM Premier ChemSTAT
- K183555 — GEM Premier ChemSTAT
- K183704 — RX-1 Rhythm Express Remote Cardiac Monitoring System
- K173937 — SpiroSphere
- K181194 — SmartMouth DryMouth Oral Rinse
- K181353 — Lunderquist® Fixed Core Wire Guide
- K181393 — Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
- K181507 — PREVENA RESTOR(TM) Incision Management System
- K181534 — CIRRUS HD-OCT
- K182293 — OsseOne Dental Implant System
- K182332 — PhantomMSK
- K182932 — RS85 Diagnostic Ultrasound System
- K183039 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K183049 — Reliance Lumbar IBF System
- K183072 — EndoFLIP System
- K183209 — 3M Comply Hydrogen Peroxide Indicator Tape
- K183217 — IPL Hair Removal Device
- K183222 — MAGNETOM Terra
- K183225 — Stabil Orthopaedic Solutions Total Knee System
- K183324 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
- K183556 — oCare Wrist Pulse Oximeter
- K190138 — MAGNETOM Aera
- DEN180058 — t:slim X2 insulin pump with interoperable technology
- K181315 — Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing
- K181930 — GMC Wrist Automatic Blood Pressure Monitor
- K182188 — Ion Endoluminal System ; Flexision Biopsy Needle
- K182677 — DynaNail Mini
- K182705 — Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
- K182756 — MyoStrain 5.1
- K183063 — Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K183083 — Shoreline Cervical Interbody RT System
- K183196 — Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
- K183206 — Dexcom G6 Continuous Glucose Monitoring System
- K183221 — MAGNETOM Amira, MAGNETOM Sempra
- K183317 — AdvantageRib System
- K183506 — HEALIX ADVANCE Anchor with DYNACORD Suture
- K183569 — DD cube ONE ML
- K183635 — PhotoFix Decellularized Bovine Pericardium
- K190074 — Presero 3D Scanning System
- K181508 — U&U Blood Collection Sets
- K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
- K182661 — Kava and Kava with Herbst
- K182874 — Fenom Pro Nitric Oxide Test
- K182915 — ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
- K182974 — NuVasive Reline System
- K182991 — EPIC Extremity Fusion Plate System
- K183161 — SnapShot Freeze 2
- K181955 — WiEMSpro
- K182934 — FORA P100 Blood Pressure Monitoring System
- K183127 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
- K183167 — Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens
- K183375 — Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
- K183637 — Cruxcan (CRX-1000)
- K190056 — KOWA VK-2s
- K190075 — Aurora Evacuator
- K180691 — TrueDorsal Devices
- K181340 — Cemented TSI Hip Stem
- K183073 — SMG Anterior Cervical Plate System
- K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus
- K183396 — HANAROSTENT FASTTM Biliary (NNN)
- K183409 — Athena II Cervical Plate System
- K183477 — easyPPHTM Hemorrhoidal Stapler for Single Use
- K183557 — Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
- K183585 — Elitone Device
- K190078 — IntraSight
- K190085 — Journey II Unicompartmental Knee System
- K180835 — SEKURE Acetaminophen L3K Assay
- K181143 — Keeler TonoCare Tonometer
- K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- K181467 — Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
- K182040 — Coala Heart Monitor
- K182833 — ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
- K183141 — LINK MP Monoblock Hip Prosthesis
- K183186 — Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24
- K183245 — Carestream DRX-1 System with DRX Plus 2530 Detectors
- K183517 — Ammonia II
- K181577 — AcQMap High Resolution Imaging and Mapping System
- K182224 — SafeAir Smoke Evacuator compact
Data sourced from openFDA. This site is unofficial and independent of the FDA.