FDA 510(k) clearances — page 305
clearances on record, most recent first.
Clearances — page 305
30,401–30,500 of 175,699- K161913 — AOS Small Fragment Plating System
- K161921 — SwiftNINJA Microcatheter
- K161935 — Avance Foam Dressing Kit - XL
- K162162 — Barrier Supreme Sterilization Wrapper
- K162284 — Puritan Fecal Opti-Swab Collection and Transport System
- K162350 — Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
- K162440 — CardioInsight Cardiac Mapping System
- K162573 — Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
- K162585 — SuniIQ Digital Radiography System
- K162595 — Trex_HD
- K162619 — I View and Imagen Sensor
- K162769 — Pinpoint GT Introducer Needle
- K152615 — Vonflex S
- K160180 — Intermittent Pneumatic Compression system
- K160349 — Electronic Sphygmomanometer
- K160437 — PleurX Peritoneal Catheter System
- K160532 — Greiner Holdex
- K160921 — CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
- K161131 — FONA Pan/Ceph
- K161157 — Vitrea CT Dual Energy Image View
- K161174 — Nanova Interference Screw
- K161373 — Nunchaku
- K161590 — MatrixRIB Fixation System
- K161592 — Persona Partial Knee System
- K161779 — MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
- K161948 — Avance Gauze Dressing Kits
- K161968 — MicrUs
- K162136 — CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System
- K162268 — Senographe Pristina
- K162801 — CastleLoc Spinal Fixation System
- K160421 — Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
- K160561 — Boosting Catheter
- K160746 — CARDIOLINE touchECG
- K161370 — Durepair Dura Regeneration Matrix
- K161378 — joimax Electrosurgical Instruments
- K161670 — Lucid Q-PTP / HWA 55
- K162095 — Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
- K160895 — Initia Total Hip System & BIOCERAM AZUL(R) HEAD
- K161454 — Propeller Sensor Model 2015-E
- K161620 — Anatomical Shoulder Domelock Dome centric
- K161974 — SLENDERTONE® Connect Abs, Type 570
- K162002 — Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay
- K162062 — AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
- K162155 — Xario 200 Diagnostic Ultrasound System V5.0
- K162358 — T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
- K162453 — 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
- K152472 — Disposable Pressure Transducer
- K160141 — miraDry System
- K160450 — Pleurx Pleural Catheter System
- K161448 — Footmotion Plating System
- K161483 — Unger Quad Injector
- K161851 — Glass Ionomer Cement (Luting)
- K162150 — BreathID Hp Lab System
- K162741 — AxoGuard Nerve Connector
- K162777 — Squirt Fluid Delivery System
- K161282 — FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
- DEN160001 — BD MAX Vaginal Panel, BD MAX Instrument
- K152533 — Xonrid Gel
- K160143 — ClearVision ExamVue Flat Panel Detector
- K160297 — Tuohy NRFit
- K160312 — FRAXIS DUO
- K160488 — Cutera enlighten III Laser System
- K160519 — Link Abutment for CEREC
- K160882 — PaX-i3D Green Premium (Model: PCT-90LH)
- K160974 — Gammex Cut-Resistant Glove Liner
- K161497 — Dental Implants and Abutments
- K161520 — ELEOS Limb Salvage System
- K161725 — Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
- K162419 — FIREFLY® Pedicle Screw Navigation Guide
- K162422 — Klassic Knee System
- K162437 — Codman EDS3 CSF External Drainage System
- K162513 — Arterys Software v2.0
- K162715 — SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
- K153332 — ETIII SA Fixture System (O3.2mm)
- K160121 — CorPath GRX System
- K160295 — SPROTTE NRFit, Quincke NRFit
- K160296 — SPROTTE SPECIAL NRFit
- K160316 — SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
- K160885 — HemosIL D-Dimer HS
- K161065 — ColpoWave Colpotomizer and CerviGrip Uterine Manipulator
- K161605 — Smart External Drain (SED) System
- K161718 — MaxBlend 2, MaxBlend Lite
- K161822 — Torcon NB Advantage Catheters
- K162169 — EdgeOne CO2 Laser
- K162256 — Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
- K162367 — Erisma® LP MIS
- K162750 — Libra Pedicle Screw System
- K160583 — REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
- K161194 — PLEX Elite 9000 SS-OCT
- K161351 — NanoBone SBX Putty
- K161393 — Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
- K161830 — Zimmer M/L Taper Hip Prosthesis
- K162138 — NuVasive CoRoent Small Ti-C System
- K162250 — FortiBridge Anterior Cervical Plate System
- K162469 — CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps
- K162514 — Multichem A1c
- K162762 — NeuroBlate System
- K160260 — Tempo Temporary Pacing Lead
- K161042 — CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
- K161973 — G-scan Brio, S-scan
Data sourced from openFDA. This site is unofficial and independent of the FDA.