FDA 510(k) clearances — page 78
clearances on record, most recent first.
Clearances — page 78
7,701–7,800 of 176,479- 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) +1 more
- 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 +8 more
- K240111 — Venue
- K240206 — Venue Sprint
- K240283 — BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) +1 more
- 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) +1 more
- 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 (7+ models)
- K240662 — Spine Guidance Software (version 5.0) +8 more
- 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)
- K240603 — Ti-Base & Master Fix
- K240648 — Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
- K241262 — Baby Gorilla/Gorilla Plating System; Monster Screw System
- K232773 — da Vinci SP Surgical System (SP1098)
- K232820 — HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
- K233971 — Arthrex AlloSync PushLock Suture Anchor
- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
- K240100 — SAM Model 9-10000
- K240222 — Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
- K240463 — Slow Wave DS8 (SWDS802)
- K240505 — Eminent Spine SI Screw System
- K240627 — LIAISON PLEX Yeast Blood Culture Assay
- K240877 — Monteris Medical NeuroBlate System
- K241258 — Ingenix Spinal System
- K231291 — Perforated Baskets
- K233587 — LOCATOR Angled Abutment (Various)
- K233751 — Milieve (YPS-301BD)
- K240251 — ANNE Chest
- K240598 — Maestro System (REF100)
- K240617 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K240834 — EcoFit® short stem cementless cpTi
- K240947 — TENSOR® Suture Button System
- K241259 — Amplatz Goose Neck Snare Kit
- K220062 — QIAstat-Dx Gastrointestinal Panel 2
- K222196 — Deep TMS System
- K223427 — Mimics Enlight CMF
- K231151 — Kenota 1 Total IgE; Kenota 1 (instrument)
- K232080 — Puracyn® Plus Antimicrobial Irrigation Solution
- K232107 — °M Warmer System
- K232333 — Anti-bacterial bandage
- K232601 — BroncTru Transbronchial Access Tool
- K232715 — Distinct® Digital Pregnancy Test
- K232738 — BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
- K232821 — S.I.N. Dental Implant System
- K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
- K233295 — LFR-260
- K233591 — Stylus
- K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881) +8 more
- K233842 — iHealth COVID-19 Antigen Rapid Test
- K240254 — Blood Pressure Monitor (TMB-2296-BT)
- K240281 — Bone Suppression Software
Data sourced from openFDA. This site is unofficial and independent of the FDA.