FDA 510(k) clearances — page 161
clearances on record, most recent first.
Clearances — page 161
16,001–16,100 of 176,479- K212415 — Arthrex Modular Glenoid System-Titanium Glenosphere
- K212444 — Qora Stool Management Kit
- K212456 — Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
- K213425 — BruxZir Esthetic
- DEN210014 — EaseVRx
- K210854 — Enteral Feeding Set
- K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
- K211697 — Esperance Aspiration Catheter System
- K211845 — Deploy Expandable Interbody System
- K212029 — Disposable Medical Nitrile Examination Gloves (non-sterile)
- K212047 — Pantheris System
- K212265 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
- K212344 — Surgical Mask
- K212455 — InZone Detachment System
- K212839 — Opulent TiNbN Coated Knee
- K212996 — Sterile PHALINX Hammertoe System
- K213071 — MOTOTM Partial Knee & MOTO PFJ Systems Extension
- K211329 — Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
- K211483 — SofWave System
- K211754 — Vital Signs Monitor
- K212301 — Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
- K212607 — Darwin
- K212695 — KARL STORZ ICG Imaging System
- K212731 — Circul8 Pro
- K212765 — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K213000 — Air Compression Massager (Model LF-FT003)
- K213254 — Axialis Ophthalmic Ultrasound System
- K213436 — Clarius Ultrasound Scanner
- K213449 — DS Implants abutments provided with the EV connection
- K213497 — ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
- K212109 — Spin Care Disposable Protective Mask Level 3
- K212575 — Surgical Face Mask
- DEN210006 — Hemolung Respiratory Assist System
- K210785 — Disposable Surgical Gowns
- K212264 — Surgical Face mask
- K202319 — Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
- K202671 — DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
- K203184 — HYDRASHIFT 2/4 isatuximab
- K210383 — Wrap Accessory Electrodes
- K210757 — ETEST Fosfomycin (FO) (0.032-512 µg/mL)
- K210989 — Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
- K211359 — Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation
- K211876 — Intellijoint VIEW
- K212259 — Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K212448 — NightGuard Flex
- K212595 — Erchonia FX-405
- K212621 — MAMMOVISTA B.smart
- K212984 — MiPACS HTML5 Web Viewer
- K212497 — Nitrile Examination Glove (Powder free, Blue)
- K212532 — Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
- K213364 — EnSite X EP System
- K201082 — LTV2 Series Ventilators
- K203746 — Venen-trainer (Model: FM150, SFM90)
- K210344 — inVisionOS
- K210779 — Powder Free Nitrile Patient Examination Gloves, Blue Color
- K211244 — VSP® Orthopedics System
- K211733 — Lunit INSIGHT CXR Triage
- K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
- K212003 — ESSENZ Patient Monitor
- K212013 — eKuore Pro 4T - REF EP0098
- K212107 — Reverso
- K212284 — Disposable Automatic Core Biopsy Instrument
- K212583 — AlignRT Plus
- K212659 — More-Cell-System
- K212887 — RTapp
- K212978 — Diode laser therapy system
- K213089 — Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
- K213389 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
- K202326 — BESPA Charcot System
- K211165 — Medical Face Masks, Model Name:MY020003
- K211206 — FreedomEdge(R) Syringe Infusion System
- K211289 — RMU-2000 Automated Chest Compression System
- K211315 — Comby EEG Caps
- K211517 — Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
- K211546 — Vektor Computational ECG Mapping System (vMap)
- K211967 — Sensual Massage, Ultra Pure
- K212331 — BodySculp
- K212526 — Surgical Face Mask
- K213383 — WHILL Model C2
- K202371 — Highspeed Airturbine Handpiece
- K203067 — Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
- K211199 — ST AIA-PACK BNP Assay
- K211356 — GIQuant
- K212068 — Biotech Dental Kits
- K212550 — Hura CTP v1.0
- K212787 — GT5 conductive & abrasive gel
- K212895 — Paragon 28 External Ring Fixation System
- K212956 — FDR Cross (DR-XD 3000)
- K212504 — Isolation Gown AAMI Level 3
- K212506 — Medical Examination Gloves (Tested for Use with Chemotherapy)
- K202110 — MStim Drop Model: LGT-233
- K202676 — Disposable Medical Face Mask
- K210253 — Best Glove-Latex Powder Free Examination Glove
- K210859 — NextAR Spine Platform
- K211055 — Microcurrent device (Model: HBR2-1)
- K211577 — SoftFix Balloon Trocar
- K211726 — Acuson SC2000 Diagnostic Ultrasound System
- K211817 — Anterion
- K211971 — Drug Relief v1
- K212044 — TrueLok Evo
Data sourced from openFDA. This site is unofficial and independent of the FDA.