FDA 510(k) clearances — page 159
clearances on record, most recent first.
Clearances — page 159
15,801–15,900 of 175,699- K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System
- K210402 — Curiteva Sacroiliac Joint Fusion System
- K210509 — Rocket Platinum Cured Cathter
- K211242 — Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
- K211352 — Electronic Thermometer (XHF2001, XHF2002)
- K211824 — HERA W9, HERA W10 Diagnostic Ultrasound System
- K212246 — Exofin Precision Pen
- K212553 — DIGITAL RADIOGRAPHY CXDI-Pro, D1
- DEN200030 — FEops HEARTguide
- K203434 — BlueStar Rx
- K203555 — AmCAD-UT
- K210712 — Verifine Mechanical Safety Insulin Syringe
- K211127 — Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
- K211235 — CIRCUL8 Luxe DVT Prevention Device
- K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K211832 — Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
- K211867 — RayStation 11.0
- K211945 — V8 Diagnostic Ultrasound System
- K212058 — Longeviti ClearFit OTS Cranial Implants
- K212495 — Leva Pelvic Health System
- K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
- K210997 — PreferX Delivery System
- K211579 — CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
- K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K211769 — OneLIF Intervertebral Body Replacement System
- K202796 — SANSIN Tubing Sets for Hemodialysis
- K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
- K212081 — 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
- K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- K202689 — Dentilube Spray
- K202786 — Dental Low-speed Handpieces and Accessories
- K203536 — Male Latex Condom
- K210133 — Current Health Monitoring System Gen 2 (G2)
- K210342 — BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
- K210470 — C-CURVE Interbody Fusion Device
- K210861 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K210940 — LuxaPrint Ortho Plus
- K211200 — WoundExpress
- K211583 — Infrared Thermometer, Model: HW-1
- K211637 — AROMA GRAND
- K211762 — Altor Safety 4-Ply Surgical Mask (Model:62232)
- K212421 — ADAS 3D
- K212476 — KARL STORZ Flexible HD Cysto-Urethroscope System
- K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter
- K201612 — Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
- K203722 — RayPilot System
- K210868 — Nitrile Examination Gloves Powder Free (Blue)
- K211074 — Univers Revers Modular Glenoid System, Standard Augment Baseplates
- K211201 — MagnetOs Easypack Putty
- K211778 — Nitrile Examination Gloves, Green/ Blue/ Black Color
- K211881 — AI Segmentation
- K212491 — Air Relax Pro Model AR-4.0
- K212494 — Lung Image Analysis
- K201258 — EASYMAX Tag Self-Monitoring Blood Glucose System
- K202204 — Tracheal Stent System
- K202395 — SP-1000, SP-2000
- K203014 — EndoLIF Delta-Cage and DoubleWedge-Cage
- K203625 — Numen Coil Embolization System; NumenFR Detachment System
- K210032 — Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
- K210254 — MeMed BV
- K210901 — Elecsys Vitamin D total III
- K210951 — Leonardo Mini Blue
- K211174 — IPL Hair Removal
- K211367 — Evo sEEG System
- K211536 — Welspun Health Surgical Mask
- K211673 — Disposable Medical Nitrile Gloves
- K211823 — Bonine Acupressure Bands
- K211972 — Omeza Collagen Matrix
- K212139 — Admiral ACP System
- K201560 — Auto Lung Nodule Detection
- K203084 — Ablamap Software
- K203636 — PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG
- K210448 — Adhesive Electrode
- K210956 — Kubtec Mozart (XPERT42)
- K210957 — Kubec Xpert 80 Radiography System
- K211449 — Triton Sacroiliac Joint Fixation System
- K211704 — CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
- K212083 — Tactoset Injectable Bone Substitute
- K212145 — DR 800 with DSA, DR 800
- K212383 — EndoNaut
- K210090 — Impulse AM Interbody Fusion System
- K210805 — Ceribell Instant EEG Headband
- K211041 — Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681
- K211322 — Paratrooper Plantar Plate Repair System
- K211630 — VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
- K211903 — Shoreline Threaded TruProfile® Plate
- K212054 — Senhance Surgical System
- K212070 — KMTI S141 Lumbar Interbody Fusion System
- K212103 — StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
- K203554 — AnyOne External Implant System
- K211255 — Surgical Mask
- K211390 — Nitrile Blue Powder-free Examination Glove
- DEN200064 — Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
- K202746 — Surgical mask
- K202752 — AXS Vecta 46 Intermediate Catheter
- K202781 — Neuspera Neurostimulation System (NNS)
- K202861 — Needle Stimulator
- K203251 — SOLOPASS System
- K203613 — ENFit Reusable Enteral Syringe
- K203696 — RBknee
Data sourced from openFDA. This site is unofficial and independent of the FDA.