FDA 510(k) clearances — page 328
clearances on record, most recent first.
Clearances — page 328
32,701–32,800 of 175,699- K153159 — Vinyl patient examination glove, Powder Free
- K151594 — Ellipse Supplemental Instrument Trays
- K152137 — FacetBRIDGE System
- K152503 — ImagenSPECT
- K152520 — Magicore System
- K152977 — DG PACS
- K153166 — Fusion Bx
- K153386 — Perla Posterior Cervico-Thoracic Fixation system
- K142541 — POCKET NEB
- K143042 — SonarMed AirWave, Airway Monitoring System
- K151048 — CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
- K151072 — Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
- K151617 — Livewire Electrophysiology Catheter
- K151996 — TAURUS C1
- K152100 — Evogue Dental Unit
- K152149 — VersaOne Bladed Trocar 5mm
- K152400 — General & Plastic Surgery Instruments
- K152447 — ASAHI Caravel
- K152497 — PW Guidewires
- K152670 — DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
- K152676 — FD TENS 2090, FD TENS 2095
- K152741 — Mepiseal Soft Silicone Sealant
- K152820 — Ponto Bone Anchored Hearing System
- K152873 — Crosstella RX Balloon Dilatation Catheter
- K152887 — Crosperio RX PTA Balloon Dilatation Catheter
- K153594 — MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
- K153679 — Stryker Neptune E-SEP Smoke Evacuation Pencil
- K150888 — Shape-HF Cardiopulmonary Testing System
- K151303 — AirLife Infant Heated Wire Circuit
- K151570 — Carestation 620/650/650C
- K152672 — Cajun Commando 4x4
- K152802 — Grasping Forceps
- K152810 — DeVilbiss DV6WM Wireless Modem
- K152833 — Pruitt F3-S Polyurethane Carotid Shunt
- K152926 — AQUACEL Ag Surgical SP Dressing
- K153034 — aap LOQTEQ VA Radius Set 2.5
- K153381 — Corin Metafix Hip Stem
- K153402 — Discovery NM/CT 670 CZT
- K153421 — HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
- K153695 — Biomet Spine Fusion System
- K153735 — Release Laminoplasty Fixation System
- K151558 — Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
- K151620 — Firefly Peritoneal Dialysis Connector Disinfection System
- K151726 — AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer
- K151959 — AirLife Infant Single Limb Heated Wire Circuit
- K152241 — Medtronic Transportation/Sterilization Cassettes
- K152311 — Pentacam AXL
- K152352 — Stereo 3D option for Vision Applications
- K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
- K152473 — CAS-One IR
- K152584 — Stroke VCAR
- K152790 — Venus Versa System
- K153626 — SonoSite Edge II Ultrasound System
- K153642 — DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
- K153643 — Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
- K153672 — basixTOUCH40 Inflation Syringe
- K153681 — PleuraFlow System
- K143713 — Lustre PRO Light System
- K151029 — Phadia Prime
- K151969 — Hospira Extension Sets
- K152215 — DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
- K152613 — True Flow Valvuloplasty Perfusion Catheter
- K152793 — Unison-C Anterior Cervical Fixation System
- K152980 — Flo Trac sensor, Volume View sensor
- K153333 — Epic Extremity Cannulated Screw System
- K153373 — CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
- K153618 — Capillus202
- K153664 — M.U.S.T. Pedicle Screw System
- K153669 — MultiFIX S Ultra Knotless Fixation System
- K143153 — EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
- K150409 — VIVACE Electrosurgical System
- K151075 — BR-ABVS Viewer 1.0
- K151081 — MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
- K151228 — PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm
- K151269 — ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
- K151320 — BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
- K151491 — Falck Medical Multifunction Tonometer, FAT1
- K151661 — Renovo Life Hard Carbon Coated Drill Bit
- K151794 — da Vinci Xi Surgical System
- K151848 — Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
- K152134 — Reprocessed Vessel Sealer
- K152450 — Esophageal Cooling Device
- K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
- K152531 — InstaClear Lens Cleaner
- K152620 — Spine Wave Gen II Expandable Interbody System
- K152669 — PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
- K152690 — DISPOSABLE THERMOMETER PROBE SHEATHS
- K152697 — INFX-8000C, V6.20
- K152777 — Bovie Disposable Bipolar Ablator
- K153289 — HEALTHMYNE
- K153598 — Medtronic Bio-Medicus Adult Cannula Kit
- K153675 — Paragon T2 Wand with Integrated Cable
- K150032 — GluStitch Twist Tissue Adhesive
- K151039 — ATLANTIS Abutment for NobelActive 3.0
- K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter
- K151468 — ARIX Wrist System
- K151487 — Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
- K151842 — Rainbow Shine
- K151846 — Rainbow LS Pressing
- K152361 — OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
Data sourced from openFDA. This site is unofficial and independent of the FDA.