FDA 510(k) clearances — page 95
clearances on record, most recent first.
Clearances — page 95
9,401–9,500 of 176,479- K222712 — Fogg System Patient Monitoring Cables
- K230529 — HealiAid Dental Collagen Wound Dressing
- K230604 — IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
- K231245 — Digital Blood Pressure Monitor (Arm Type)
- K231797 — Medifun Lancing Device, Model No. LD-E1
- K232593 — FITme Customized Silicone Implant
- K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels
- K232621 — Blood pressure monitor
- K232635 — IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
- K233078 — Posterior Cervical Spine System
- K233110 — Carnation Ambulatory Monitor
- K221606 — Absorbable Cranial Flap Fixation System
- K222511 — Oxy2Pro
- K223615 — Digital ClarusScope System, Digital NeuroPEN System
- K230211 — CranioXpand
- K230287 — SaviSafe Safety Device
- K230641 — Ultrasonic Scaler Tips
- K230773 — Endoscopy Irrigation Tubing
- K230834 — CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
- K231443 — Mini-OSTEO Pedicle Fixation System
- K231975 — PNK Total Knee System
- K232001 — Nu Skin RenuSpa iO
- K232388 — High Pressure Tubing
- K232496 — Brainomix 360 Triage Stroke
- K232546 — Meta G UCLA Abutment
- K232549 — NemoCast
- K232573 — INFINITI Ambi Angiographic Catheter
- K232576 — Medical Nitrile Examination Gloves
- K232719 — ProMIS Extension Rod System
- K232898 — Quantisal Oral Fluid Collection Device
- K232977 — Biophotas Celluma CONTOUR
- K232988 — Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
- K233010 — Beagank 4T Plus
- K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator
- K233053 — DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
- K233084 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
- K233191 — TotalTi ACDF by SAGICO
- K233245 — MagnetOs Flex Matrix
- K233333 — KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
- K230627 — Zilia Ocular FC (ZIL-10002)
- K230700 — RIWOtrack Navigation System
- K231498 — TraumaCad Neo
- K231692 — Ziehm Vision RFD
- K231941 — ARIETTA x10
- K232545 — The SensiTox B. anthracis Toxin Test
- K232555 — Harmony
- K232575 — Hair Removal Device, Model(s): R2815-G Pro, R2815-G
- K233346 — Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005) +4 more
- K233351 — Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M) +4 more
- K230190 — Polyver Silver Alginate Dressing (Prescription and OTC)
- K230589 — Celox Rapid X-Ray Gauze
- K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin
- K230954 — Samfilcon B Custom Contact Lens
- K231020 — Alinity c Tricyclic Antidepressants Reagent Kit
- K231559 — Multi-Unit DAS System
- K231600 — SENDERO Microcatheter
- K232028 — Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
- K232501 — AI Platform (AIP001)
- K232512 — Masimo W1
- K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
- K232925 — Gastric Alimetry System
- K232974 — EKGenius Smart System
- K230451 — Aptima® Chlamydia trachomatis Assay
- K231445 — LINK Embrace Shoulder System - Reverse Configuration
- K231652 — D100 KIDS; D101 KIDS
- K231694 — MASADA Modular Spinal Fixation System
- K231738 — NEUWAVE Microwave Ablation System and Accessories
- K232139 — Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
- K232392 — CT Lung Ventilation Analysis Software (CT:V)
- K232521 — ExactechGPS® Total Ankle Application
- K232533 — ROSA Partial Knee System
- K232753 — EXPD 4343D; EXPD 3643D
- K232921 — DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric
- K232945 — Trio-CT® Triple Lumen Catheter w/ Curved Extensions
- K233200 — XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
- K233302 — OSSIOfiber® Compression Staple
- K233443 — Vital Navigation System
- DEN200070 — Simple 2 Test
- K223414 — Curing Light, Model: MaxCure 9
- K230463 — NSite Scoliosis Assessment App
- K231012 — CoolSeal Trinity
- K231818 — METIC- Airway Balloon Catheter
- K231852 — BinkieRT
- K232841 — Axial3D Insight
- K232973 — Arthrex Knee FiberTak® Button Suture Anchor
- K230856 — BrainSpec Core Software
- K230878 — QScout Lab; QScout RLD
- K231097 — Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems
- K231521 — Broncho Videoscope System
- K231554 — UniPearls® Embolic Microspheres
- K231783 — VitroPRO
- K232050 — saremco print BRIDGETEC
- K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2)
- K232461 — Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +3 more
- K232494 — MAGNETOM Avanto fit; MAGNETOM Skyra fit
- K232656 — BLU TOTALE (Model: ENEOB852)
- K232845 — IPL Cooling Hair Removal Device
- K233434 — Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)
- K233468 — Iconix Anchor
- K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
Data sourced from openFDA. This site is unofficial and independent of the FDA.