FDA 510(k) clearances — page 233
clearances on record, most recent first.
Clearances — page 233
23,201–23,300 of 176,542- K191388 — FloPatch (FP110)
- K191400 — Voyager Trajectory Array Guide (V-TAG)
- K182285 — PK High Tibial Osteotomy Correction System
- K182742 — DB-CMF
- K183354 — Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
- K183450 — EmBody System
- K183580 — Panthera Dental Milled Bars
- K183624 — Kubtec Mozart (Xpert42)
- K190095 — Powder-Free Clear Vinyl Patient Examination Gloves
- K190122 — Renovis A200 PS Knee System as part of the Renovis A200 Knee System
- K190336 — Soniquence Bipolar Electrodes
- K190545 — VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
- K191172 — Cepheid Xpert MRSA NxG Control Panel
- K191442 — Campylobacter Chek
- K191456 — Campylobacter Quik Chek
- K182638 — Hailie Sensor
- K182658 — Bioliner
- K182703 — EntericBio Dx Assay
- K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
- K182774 — STOP U (Packed Black USA), STOP U (Packed White USA)
- K182785 — LOQTEQ VA Foot Plates 2.5
- K190115 — MHD TENS
- K190387 — RayStation
- K190762 — The JASPER Spinal Fixation System II
- K190889 — Republic Spine Restore Cervical Interbody Fusion System
- K191418 — Multix Fusion Max
- K182493 — Bovine Pericardial Tissue Patch
- K182667 — Med-link Temperature Probes
- K183385 — NanoKnife System
- K183578 — Torpedo Gelatin Foam
- K190913 — QLAB Advanced Quantification Software 13
- K191049 — Stryker MIS and Footed Attachments
- K191209 — Aneroid Type Blood Pressure Kit
- K182524 — GALILEO Spine Alignment Monitoring System
- K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
- K190121 — IDS SHBG
- K190662 — MRI Compatibility for Existing Straumann Dental Implant Systems
- K190663 — Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
- K190684 — LxHA PEEK Lateral IBF System
- K190936 — Q-Switched Nd: YAG Laser System
- K191368 — FlowTriever Retrieval/Aspiration System
- K190010 — Penumbra System Reperfusion Catheter JET 7
- K183195 — VIVO
- K183219 — Trio-CT Triple Lumen Catheter
- K183263 — UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
- K183431 — Medline Digital Rectal Thermometer Sheath
- K183566 — CLARITY II Laser System
- K190172 — Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
- K190414 — Moss Gastrostomy Tube, Moss Nasal Tube Mark IV
- K190700 — ELECTRODES PAD
- K191299 — Silhouette Featherlift / Silhouette Lift
- K191318 — AEQUALIS FLEX REVIVE Shoulder System
- K191387 — ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
- K181514 — SeraQuest HSV Type 2 Specific IgG
- K181965 — Restore Toothpaste
- K182159 — Strome-Blitzer Cytology Balloon
- K182608 — Oyster ACIF Cage
- K183363 — Treace Medical Concepts (TMC) Snap-Off Screw System
- K183460 — ClariCT.AI
- K183513 — XenoSure Dura Biologic Patch
- K183564 — Electrosurgical Generator
- K190117 — Fiberoptix IAB
- K190133 — Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
- K190228 — Transcranial Doppler Ultrasound System
- K190424 — HealthICH
- K190667 — Sonopet iQ Sterilization Tray
- K191005 — ProLift® Expandable System
- K191036 — SyMRI
- K191089 — Edwards Pressure Cable
- K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- K172232 — LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
- K180511 — Eon FR
- K182749 — Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
- K183046 — Aquilion ONE (TSX-305A/6) V8.9 with AiCE
- K183335 — Medline Poly-Cath Red Polymer Urethral Catheter
- K183691 — PENTAX Medical ENT Video Imaging System
- K183692 — Avid IF2
- K190016 — Lateral Plate System
- K190177 — J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
- K190185 — Phasix ST Mesh with Open Positioning System
- K190422 — Viveve System 2.0
- K190521 — Aequalis Ascend Flex Shoulder System
- K191038 — On Call Express Voice Blood Glucose Monitoring System
- K191055 — HS40 Diagnostic Ultrasound System
- K191064 — Argon Handset
- K191115 — RS85 Diagnostic Ultrasound System
- K191291 — Wallace Dual Lumen Oocyte Recovery System
- K191331 — Life Sensor Cardiac Monitor
- K182416 — NOVA Minimally Invasive System
- K182656 — JAMBRO Single Core A Sterilization wrap
- K182713 — Scoreflex PTA Scoring Balloon Catheter
- K191226 — Arthrex SwiveLock Suture Anchor
- K191268 — Force Fiber Suture
- K191271 — T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
- K191285 — Spine & Trauma Navigation
- K182650 — Arzzt Distal Radius and Ulna System
- K183104 — Mini Cannulated Headed and Headless Screw Set
- K183630 — SPINEART Navigation Instrument System
- K190220 — Vista FS, Vista FS Liquid
- K190814 — AccuFill Bone Substitute Material
Data sourced from openFDA. This site is unofficial and independent of the FDA.