FDA 510(k) clearances — page 222
clearances on record, most recent first.
Clearances — page 222
22,101–22,200 of 175,699- K190488 — ProLift Expandable System
- K190926 — Hammertoe Truss System (HTS)
- K190963 — DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
- K191662 — Vantage Orian 1.5T, MRT-1550, V4.5
- K182817 — CottonDay Tampon
- K182985 — Roadrunner PC Wire Guide, Olcott Torque Device
- K190834 — Corin Optimized Position System Functional Hip Analysis (OPS FHA)
- K190975 — Plexus SCD110 Sequential Compression Device Sleeve
- K191078 — BAROnova Access Sheath Kit
- K191092 — Powder-Free Vinyl Patient Examination Gloves, Yellow Color
- K191374 — Revival Modular Hip Stem
- K191593 — Digital Automatic Blood Pressure Monitor MD36 Series
- K182487 — CerusEndo Microcatheter
- K191660 — CARTO 3 EP Navigation System, Version 7.1 and Accessories
- K182407 — Exceed Microneedling device
- K182798 — KIDScore D3
- K182940 — Surdial DX Hemodialysis System
- K182971 — SpaceOAR Vue Hydrogel
- K183349 — AeroDVx System
- K183545 — Anspach Helix Dissection Tools
- K190050 — Tech Dots - Adhesive and conductive gel
- K190260 — STERIZONE(R) VP4 Sterilizer
- K191117 — NvisionVLE Low-profile Optical Probe
- K191309 — syngo.via MI Workflows VB40A, Scenium
- K191365 — Stat Profile Prime ES Comp Plus Analyzer System
- K191467 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
- K191633 — Infyna Chic
- K191648 — Mariner MIS Pedicle Screw System; SeaSpine Navigation System
- K191757 — EUROPA Pedicle Screw System
- K181166 — Trilogy Evo
- K181170 — Trilogy Evo Universal
- K182794 — BionicGym Powered Muscle Stimulator
- K182908 — Ziacom Dental Implant Systems
- K183121 — Qraypen
- K183532 — Latitud Hip Replacement System
- K190343 — Silverlon Wound Contact, Burn Contact Dressings
- K190427 — Immucise
- K190492 — Peralta Stone Removal Catheter
- K190680 — FAVO S-TLIF
- K190895 — MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
- K191048 — AcuSnare Polypectomy Snare - Duckbill
- K191060 — ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
- K191140 — MONTAGE-QS Settable, Resorbable Hemostatic Bone
- K191370 — DreaMed Advisor Pro
- K191598 — AOS ES Retrograde Femoral Nail
- K191615 — Huvitz Imaging System
- K191755 — SPAR-K Instruments (for use with Gemini SL Total Knee System)
- K182820 — The POD
- K183270 — Silent Nite sl
- K191053 — Xtreme-Loop
- K191068 — Powersculp laser lipolysis system
- K191167 — Fungitell STAT
- K191345 — Pegasus System
- K191578 — ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
- K191711 — ORTHOLOC SPS Shoulder Plating System
- K180992 — Biotex
- K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
- K183572 — FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
- K183663 — Microlife Digital Infrared Ear Thermometer
- K190150 — Sage 2-in-1 Personal Lubricant and Moisturizer
- K190163 — ALARA Neuro Access Kit
- K190575 — iBreastExam
- K191287 — OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners
- K191325 — EMPOWR Partial Knee
- K191608 — Impress Angiographic Catheter
- K191616 — Orthophos S
- K182158 — UNiD Patient-matched PLIF cage
- K182455 — A.B. DENTAL DEVICES Dental Implants System
- K182814 — Rael Tampon
- K190123 — MicroPort CoCr Femoral Heads
- K190749 — 087 Balloon Guide Catheter System
- K191372 — Lyra
- K191635 — Optilite IgM Kit
- K173974 — DROWZLE
- K183325 — Modus Nav
- K182091 — Osstem Abutment System
- K182714 — Novidia Bulk Fill Flow Composite
- K182930 — PerioLase Nd:YAG Pulsed Dental Laser System
- K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe
- K190457 — VERITON CT whole body SPECT/CT system
- K190972 — Ambu aScope 4 RhinoLaryngo Intervention
- K190976 — Radial Medical Compression System
- K190999 — SureForm 45 Curved Tip, SureForm 45 Gray Reload
- K191050 — MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow
- K191259 — Stryker CrossFlow Integrated Arthroscopy Pump
- K191272 — Wearable Device, Wearable Package
- K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC)
- K191317 — StitchKit
- K191585 — iNtuition-Structural Heart Module
- K191601 — Valleylab FT10 Electrosurgical Platform
- K181418 — ScopeFlow Pure(TM)
- K181457 — EndoStream(TM)
- K182854 — GC FujiCEM 2 (Improved)
- K190229 — Stryker PEEK Customized Cranial Implant Kit
- K190694 — Unifi Workspace v1.0.0
- K190718 — Zygomatic Implants
- K190960 — Nalu Lead Blank (50cm)
- K191138 — AeroForm Tissue Expander, Smooth
- K191482 — Senhance Surgical System
- K191534 — ID NOW Influenza A & B 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.