FDA 510(k) clearances — page 69
clearances on record, most recent first.
Clearances — page 69
6,801–6,900 of 175,620- K233238 — Air Pressure Therapy System (Model:VU-IPC4M)
- K233254 — TELIGEN System Navigation Ready Instruments
- K233496 — EndeavorOTC
- K233707 — HFT150
- K233955 — Clarius OB AI
- K233991 — CanGaroo RM Antibacterial Envelope
- K240002 — G-Vitri Vitrification Straw
- K240124 — BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
- K240696 — Airdog X8 Air Purifier (KJ800F-X8)
- K240721 — ExcelsiusFlex
- K240729 — Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)
- K240817 — VersaWrap
- K241082 — INNOVERSE Navigation Instruments
- K241083 — SIS System
- K241250 — 3DMax Light Mesh
- K241407 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
- K231060 — ProMin Dental Desensitizing Gel
- K232930 — VERVE
- K232953 — AquaBplus; AquaB LITE
- K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214C
- K233662 — Radiography 7300 C
- K233821 — F&P Optiflow Oxygen Kit (AA451J)
- K233892 — 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
- K233925 — Relu Creator
- K240017 — InMode System with the Morpheus8 90 Applicator
- K240149 — Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium
- K240460 — FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
- K240815 — Arthrex Cannulated Screw System
- K241358 — BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
- K241370 — Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
- K241499 — 21.3 5MP Color LCD Display UMD5-21B01
- K232950 — Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
- K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
- K233007 — Picosecond Nd:YAG Laser System; PICO LEGEND
- K233266 — MEDIBLU ECG SYSTEM
- K233610 — ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System
- K233613 — ACUSON SC2000 Diagnostic Ultrasound System
- K240050 — SOUNDSTAR CRYSTAL Ultrasound Catheter
- K240256 — Remunity System
- K240504 — PLASMA EDGE System
- K240516 — RS85 Diagnostic Ultrasound System
- K240876 — Identity Shoulder System
- K240910 — EO Chex Indicator Tape
- K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
- K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
- DEN230069 — Mi-CHORD System
- K221547 — InActiv Blue
- K230546 — SIGNEX
- K232749 — DOOPANG
- K241011 — Mako Total Knee Application
- K241025 — JADE PLUS PTA Balloon Dilatation Catheter
- K241344 — MetriCide OPA Plus Solution Test Strip
- K232911 — KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
- K233767 — OmniTom Elite
- K234106 — Venue Fit
- K240053 — Venue Go
- K240106 — Histofreezer V
- K240108 — Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)
- K240111 — Venue
- K240206 — Venue Sprint
- K240283 — BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
- K240644 — Medical Diode Laser (S1Pro)
- K241399 — Indigo® Lightning Flash Aspiration System Select + Catheter
- K231010 — Corvair
- K232035 — Impala
- K232625 — Steriking® Pouch for Robotic Instruments
- K232804 — FibriCheck
- K232806 — HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
- K232816 — Electrocardiograph, model: ECG301
- K232837 — Uro-G HD Flexible Cystoscope
- K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
- K232969 — Disposable Hemostatic Clips
- K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
- K233861 — Libre Rio Continuous Glucose Monitoring System
- K234042 — EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
- K234099 — Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
- K240570 — IPD Dental Implant Abutments
- K240672 — Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)
- K240832 — Blood Pressure Monitor (BBZ32-AA01)
- K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
- K241038 — Cardiac CT Function Software Application
- K241069 — iLoop Interventional Coil 0.55T
- K241423 — Access Thyroglobulin
- K232774 — Wearable Breast Pump,Model S18
- K232968 — Grande Medical Masks, Model SF-600
- K233094 — Wellead® Latex Foley Catheter
- K233824 — Swan-Ganz catheter
- K240202 — Conical Platform Dental Implants System
- K240657 — ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-
- K240662 — Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
- K240948 — TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
- K240951 — Invictus Robotic Navigation Instruments
- K240963 — Spinal System
- K240965 — CORTRAK* 2 Enteral Access System (20-0950)
- K241304 — WaveSense Jazz Blood Glucose Monitoring System
- K233008 — Cannulated Headless Bone Screws
- K240008 — Mobility Scooter (W3331)
- K240187 — Tapered Pro Conical Implant System
- K240211 — VELYS Robotic-Assisted Solution
- K240358 — ShockPhysio Mobile (model SW3200 Basic)
Data sourced from openFDA. This site is unofficial and independent of the FDA.