FDA 510(k) clearances — page 177
clearances on record, most recent first.
Clearances — page 177
17,601–17,700 of 176,479- K202971 — DRPx Locking Distal Radius Plate System
- K203183 — CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
- K203640 — CoolSeal Reveal
- K210066 — ImagePilot
- K210191 — Identity Imprint Knee Replacement System
- K210353 — AutoCap RX
- K210529 — Dr. Yglo Wart Remover
- K210705 — Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3
- K210728 — CONDUIT Instruments
- K211034 — Corvus Radiation Therapy Planning System
- K200765 — Genius / Genuin Total Knee System
- K203525 — D function
- K210298 — GR-14 Resin System
- K210451 — OrthoGold 100
- K211008 — Bose SoundControl Hearing Aids
- K211112 — OIC External Fixation System
- K200768 — Rebellion, Phantom Multi-Bite Kerrison Rongeur
- K200893 — ProntoPump Sterile Tube Set
- K201152 — Electric Breast Pump
- K201671 — A-Link Z
- K202521 — PtoleMedic System
- K202921 — Uro-G Cystoscope
- K203135 — Medline Vacu-line Suction Aspirator
- K203192 — NaviCam Xpress Stomach System
- K203218 — CaP Spheres Pellet Pack
- K203450 — EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
- K203529 — VASSALLO GT Hybrid
- K203655 — Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
- K203698 — CoLink Sfx Implant System
- K210304 — Surgical Mask
- K210669 — Quantum Mini Ventilation Module
- K210682 — SOTA Cloud Imaging
- K203409 — MC3 Crescent Jugular Dual Lumen Catheter
- K203710 — Storz Medical MAGNETOLITH Muscle Stimulator
- K203749 — Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
- K210675 — EasyWhip
- K201949 — Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
- K202430 — Kerecis Reconstruct
- K203165 — Disposable Ureteral Access Sheath
- K203267 — The BioBrace Implant
- K203580 — ArtiSential Laparoscopic Instruments-Electrodes
- K203601 — Innova Nasal Non-Vented Mask
- K203699 — syngo. CT Extended Functionalities
- K203786 — MAC 7 - Resting ECG Analysis System
- K210001 — HYPER AiR
- K210061 — ProLift Lateral HELO Fixated
- K210247 — OsteoCentric Integrated Hip Fastener System
- K210290 — JACE Medical Thoracic Plating System
- K210637 — CD Horizon Spinal System
- K210647 — SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
- K210919 — AcuityDRe
- K210993 — CereLink ICP Monitor
- K211013 — FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
- K201024 — Expandable Titanium PLIF/TLIF System
- K202457 — M1 Surgical Face Mask
- K202619 — KardiFlex PTCA Balloon Dilatation Catheter
- K202987 — Rescue Pulmonary Grasping Forceps
- K203454 — Infrared Thermometer
- K210605 — 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
- K210944 — Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
- K210981 — Pure Vu System
- K200391 — MPACT Extension
- K202757 — CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
- K203277 — Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
- K203436 — Disposable Nitrile Examination Gloves
- K203451 — TCL3 Motion Tracking System
- K203532 — BI-MENTUM ALTRX® Dual Mobility Liner
- K203535 — Trinias
- K210020 — Medical Mask
- K210242 — Astroglide X Silicone Personal Lubricant
- K210278 — Titan SGS
- K210601 — Plato 17 Microcatheter
- K210621 — Oral/Enteral Syringe
- K210925 — Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
- K210982 — AMX Navigate
- K210985 — 1717FCC
- K191951 — Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device
- K203098 — STARband, STARlight, St. Louis Band
- K203121 — Responsive Arthroscopy Thunderbolt System
- K203240 — AccelX Abutments
- K210609 — AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
- K210660 — Stone Retrieval Balloon Catheter
- K210964 — Resonic Rapid Acoustic Pulse Device
- K211072 — Safety Trocar Cannula
- K193070 — VIVACE Electrosurgical Device
- K200260 — Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
- K202258 — ERISE Laser handpiece
- K202464 — Vital Sign Monitoring Sensor (Model :XK300)
- K202647 — Surgical Mask
- K203264 — MicroDose Injector
- K203512 — Powder Free Blue Nitrile Examination Glove
- K210347 — VSP System
- K210663 — Dermatological Diode Laser Systems
- K210918 — da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
- K211010 — Illusion Aligners
- DEN200046 — Neurolutions Upper Extremity Rehabilitation System
- K192190 — Solax Electric Scooter
- K201853 — Naton Disposable Surgical Face Mask
- K202043 — Secret Duo
- K202257 — Dermatological Diode Laser Systems
Data sourced from openFDA. This site is unofficial and independent of the FDA.