FDA 510(k) clearances — page 232
clearances on record, most recent first.
Clearances — page 232
23,101–23,200 of 175,699- K180127 — TCAT (R) THA Instrument Tray Set
- K181633 — MTF Pre-Sutured Tendon
- K182022 — ApexMV
- K182571 — CardioFlux with Faraday Analytical Cloud
- K182639 — MOBILETT Elara Max
- K182813 — COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
- K182853 — HORIZON TMS Therapy System
- K183187 — nextaro Transfer System, nextaro va
- K183426 — MectaLIF Anterior Stand Alone Extension
- K183493 — SelectSite C304-HIS Deflectable Catheter System
- K183501 — Parcus Twist AP Suture Anchors
- K183657 — Vantage Galan 3T, MRT-3020/A9, V5.0
- K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
- K190280 — Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly
- K190294 — CELL-DYN Emerald 22 AL System
- K190347 — HIVOX OTC Electrical Stimulator
- K190357 — Star-X, Intraoral X-ray System
- K190373 — SonialVision G4
- K190401 — MAMBA and MAMBA Flex Microcatheters
- K190476 — FUJIFILM Sonosite Vevo MD Imaging System
- DEN170044 — ClearMate
- K180337 — EUROPA Pedicle Screw System
- K181669 — ConvertX Biliary Stent System
- K182203 — JKH Stimulator Plus
- K182371 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- K182475 — Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
- K182579 — Omron Model BP7900 Blood Pressure Monitor + EKG
- K182589 — BD Plastipak Syringe
- K183142 — PathVisionXL
- K183247 — dpl Faceware
- K183380 — Tetric PowerFill
- K183573 — Vstrip H. pylori Antigen Rapid Test
- K190168 — Aquas Probes
- K190283 — PROSTIM Injectable Inductive Graft
- K190285 — L300 Go System
- K190318 — VASOBand Vascular Compression Device
- K190326 — VITROS XT Chemistry Products UREA-CREA Slides
- K181668 — FasTouch Absorbable Fixation System
- K182502 — Alteon Acetabular Cup System
- K182570 — Venture 0.014 Catheter
- K182920 — MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES PEEK Anterior Lumbar Interbody Fusion (ALIF)
- K183026 — Wright Jones Fracture System
- K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional
- K183238 — BeneVision Central Monitoring System
- K183430 — Modular Spinal Fixation System
- K183463 — AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
- K183464 — AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
- K183472 — DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional
- K183492 — JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
- K183600 — Anchor Bag-Alone Tissue Retrieval System by ConMed
- K190296 — GammaTile
- K190300 — BIOK7600W Wireless Flat Panel Detector
- K190311 — BIOK7600 Flat Panel Detector
- K190368 — Enhanced Feature Software Pack CXDI Series
- DEN180017 — Quantra Hemostasis Analyzer, QPlus Cartridge
- K181447 — Safety insulin needle for single use
- K181610 — ActivOrtho Nitinol Compression Screw System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.