FDA 510(k) clearances — page 158
clearances on record, most recent first.
Clearances — page 158
15,701–15,800 of 176,479- K210077 — MED RF 4000
- K210102 — Topwide Surgical Face Mask
- K210825 — Revitive Medic Coach (Model Number 5575AQ)
- K210871 — PDO Max Suture with Dual Needle
- K210914 — Sterile Syringe for Single Use
- K210931 — Libby IAAA v1.0
- K211172 — Single Use Electrosurgical Knife with Fluid Pump System
- K211209 — Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves
- K211531 — Cordless Prophy System, Model: i-Polish
- K212059 — Surgical Face Mask
- K212340 — EMBOGUARD Balloon Guide Catheter
- K212872 — Avenger Radial Head System
- K213381 — Physica system
- K213397 — InkSpace Imaging Pediatric Body Array
- K213627 — RF Vapor System
- K213644 — Arthrex Knotless Mini TightRopes
- K213715 — Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT +3 more
- K202803 — Activmotion S DTO
- K202818 — Voyant Fine Fusion Device (EB230)
- K210355 — Surgical Gown, Model: surgical gown-hp-3
- K211217 — Profound Matrix
- K211277 — Theia NPWT Foam Wound Dressing Kit
- K211378 — LM Surgical Mask Level 3, LM Surgical Mask Level 2,
- K211471 — Balanced Knee System Uni
- K212055 — Connected OR Hub with Device and Voice Control
- K212402 — MIVI Q Distal Access Catheter
- K212420 — Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
- K212616 — Koios DS
- K212630 — Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
- K212645 — AT
- K212898 — Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs
- K212985 — 6MP Color LCD Monitor CL-S600
- K213020 — IPL hair removal machine
- K213407 — UltiCare Disposable Pen Needles
- K213463 — NightOwl
- K213628 — VBrain
- K213733 — Ponto 5 SuperPower
- K213916 — ArchForm Orthodontic Software System
- K200176 — FREEDOM Integrated Syringe Infusion System
- K202822 — Helianthus
- K202823 — Innomed NPWT Silicone Foam Dressing
- K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
- K210223 — Transcutaneous Electrical Nerve Stimulator
- K210405 — ProTEC-USA EZDoff Gown
- K210965 — reVive Light Therapy Essentials
- K211039 — BIT-Motion
- K211114 — Will3D
- K211539 — Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
- K211803 — HealthPPT
- K212351 — Revolution Peripheral Atherectomy System
- K212398 — Surgical Face Mask (Non-sterile)
- K212781 — Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate
- K212817 — Merit Siege Vascular Plug
- K212861 — Surgical Gown, Reinforced Surgical Gown
- K212903 — SIMPACT Sacroiliac Joint Fixation System
- K212919 — Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
- K212944 — Disposable Surgical Mask
- K213092 — Cellusheet, Cellufil
- K213155 — RT-Mind-AI
- K213443 — Insignia Anterior Cervical Plate System
- K213631 — Chocolate PTA Balloon Catheter
- K213728 — Serranator PTA Serration Balloon Catheter
- K200932 — Blood Collection Needles
- K202848 — S2 Pigment Removal System
- K203716 — PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System
- K210481 — Instant 20s Indicator
- K210744 — Surgical Mask
- K210827 — ZEPTO Precision Capsulotomy System
- K212538 — DESS Dental Implants
- K212574 — Surgical Face Mask
- K212675 — Aspira Peritoneal Drainage System
- K212832 — TimeWaver Frequency
- K212904 — SeaSpine WaveForm C Interbody System
- K212958 — MRIdian Linac System
- K213029 — Nitrile Examination Gloves (Powder free, Blue)
- K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular Device
- K202794 — Surgical face mask: F-Y1-A
- K210388 — Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color
- K211572 — Aesculap Slim Clip Applier
- K211942 — Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
- K212060 — neXus Ultrasonic Surgical Aspirator System
- K212186 — Philips Radiology Smart Assistant
- K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
- K212428 — Centerpiece Plate Fixation System
- K212706 — SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
- K212869 — Disposable Surgical Gown, Disposable Reinforced Surgical Gown
- K212890 — Nyquist.IQ
- K212918 — Heat StimPlus
- K212924 — Nitrile Examination Gloves
- K212925 — Disposable Surgical Gown
- K213069 — CoLink NeoFuse Plating System
- K213176 — Disposable Nitrile Powder-Free Examination Gloves
- K213700 — MULTIX Impact, MULTIX Impact C
- K212085 — Siam NTD+ Nitrile Powder-Free Examination gloves
- K212182 — Iconic Nitrile Glove
- K212840 — Nitrile Gloves (Model: NE01)
- K212867 — Medical Surgical Mask
- K212899 — Disposable Vinyl/Nitrile Blend Medical Examination Gloves
- DEN200041 — Comfort Marker 2.0.
- K201600 — Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28
Data sourced from openFDA. This site is unofficial and independent of the FDA.