FDA 510(k) clearances — page 241
clearances on record, most recent first.
Clearances — page 241
24,001–24,100 of 176,542- K182771 — ISS-JAZZ Screw System and JAZZ CAP SP
- K183176 — Endotoxin Activity Assay (EAA)
- K183180 — Caiman 5 Maryland
- K183232 — Double ENDOBUTTON Fixation Device
- K183437 — AirRay Subdural Cortical Electrodes
- K183440 — CRYOcheck FVIII Inhibitor Kit
- K183446 — BioPlex 2200 Lyme Total
- K183469 — Microlife Digital Blood Pressure Monitor
- K183524 — VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
- K183603 — INnate Cannulated Screw System
- K183610 — Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
- K181823 — KardiaAI
- K182013 — EasyInstruments
- K182241 — Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
- K182313 — BoneTrust Implant System
- K182553 — Inno-Pathwire
- K182789 — KLS Martin Individual Patient Solutions (IPS) Planning System
- K183236 — Rotium Bioresorbable Wick
- K190253 — EVOS Small Fragment Upper Extremity Plates Line Additions
- K173064 — ZAPnea Oral Appliance
- K182537 — RADMAX Digital Imaging Software
- K182799 — Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
- K182995 — Bariatric Power Positioning System (BPPS)
- K183085 — CoreDx Pulmonary Mini-Forceps
- K183092 — Kuros TLIF Cage
- K183177 — Nitinol Thermocouple (TCN) Electrode
- K183285 — cmTriage
- K183303 — Brainsway Deep TMS System
- K183448 — NewTom 5G XL
- K190039 — EchoSure Diagnostic Ultrasound System
- K190146 — Nexus DR Digital X-ray Imaging System
- K190153 — RadiForce MX216
- K190201 — CORUS Spinal System
- K190206 — DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
- K190224 — Medline Burn and Wound Dressing (OTC)
- K190256 — Rulo Radiofrequency Lesion Probe
- K190276 — Provident II Hip Stem
- K173518 — Spectrum Spine Expandable Cages (SSEC)
- K180880 — DARI Health
- K181165 — Philips wearable biosensor-G5 Solution
- K182311 — Cervella
- K182344 — RhythmAnalytics
- K182413 — Electric Breast Pump
- K182870 — Introcan Safety 3 Closed IV Catheter
- K183078 — VitalConnect Platform, VitalPatch Biosensor
- K183373 — Bonebridge
- K183551 — VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
- K190055 — Duo Lumbar Interbody Fusion Device
- K190098 — Endophys Pressure Sensing Sheath
- K190141 — HANAROSTENT LowAx Colon/Rectum (NNN)
- K190184 — iSLEEVE Introducer Set
- K181682 — VISULAS green
- K181807 — Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
- K181859 — Visualase Thermal Therapy System
- K182173 — Joule System
- K182966 — PLANET Onco Dose
- K183201 — Hearing Healthcare Pro
- K183289 — ClearGrasp Snare
- K183366 — GenePOC Strep A
- K183397 — ChoiceSpine Stealth Cervical Spacer System
- K180842 — MAC Medical D-Series Blanket and Solution Warming Cabinets
- K181656 — ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
- K182628 — Imagio Ultrasound Imaging System
- K183053 — Olympus Small Intestinal Capsule Endoscope System
- K183172 — Stryker SternalPlate System
- K190030 — Embrella Endoscopic Distal Attachment
- K181782 — Medline Reinforced Epidural Catheter
- K181843 — MLP Special Locking Bone Plate System
- K182225 — Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
- K183384 — JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
- K183453 — VS3-IR
- K190193 — SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
- K190322 — SCARLET® AC-T Secured Anterior Cervical Cage
- K182495 — Electronic Blood Pressure Monitor
- DEN180021 — Early Bird Bleed Monitoring System
- K173793 — XactTrace Single Use Respiratory Effort Belt System
- K180050 — CurvaFix Intramedullary Rodscrew System
- K180852 — Manual Wheelchair
- K181475 — DxH 520 Hematology Instrument
- K181730 — BD Vacutainer Eclipse UltraFill Blood Collection Needle
- K181788 — Lead-free Chemical Indicators for Steam Sterilization
- K181871 — EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
- K181932 — DTX Studio design
- K182710 — Fetal Doppler, Model FD88
- K182804 — Traditional Length GJ Feeding Device
- K182822 — Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
- K183067 — Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
- K183147 — BrackFix
- K183259 — Idys TLIF TiVac
- K183266 — EP-TRACER System
- K183401 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K183402 — PRO-LITE Sterilization Tray
- K183478 — ClearON Mobile
- K183690 — Tenodesis Screw System
- K183702 — Polar Care Wave
- K183705 — IdentiTi Porous Ti Interbody System
- K190007 — Vydence Laser Family
- K190234 — ODI HD Dental Sensor
- K180479 — ReDS System
- K181528 — Austin Miller Large External Fixation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.