FDA 510(k) clearances — page 215
clearances on record, most recent first.
Clearances — page 215
21,401–21,500 of 175,699- K191668 — Infrared Forehead Thermometer (Model IR-FT)
- K191723 — ATEC IOM Accessory Instruments
- K191943 — SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
- K192325 — Quantum Blood and Fluid Warming System
- K192593 — Confirm Rx Insertable Cardiac Monitor
- K192598 — Bashir S-B Endovascular Catheter, Ref. No. 7101
- K192760 — NuVasive Modulus XLIF Interbody System
- K182073 — BcSs-PICNI-2000 Sensor
- K183503 — EasyMark Tissue Marker
- K190102 — DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System
- K190162 — SmartCeph
- K191216 — Voxel Dosimetry v1.0
- K191653 — Freestyle Flex
- K191942 — MT One Diamond
- K192175 — On Call Express II Blood Glucose Monitoring System
- K192239 — WavelinQ Plus EndoAVF System
- K192316 — Matrix HA PEEK Cervical Implant System
- K192441 — Arthrex SwiveLock Anchors
- K192455 — Merge PACS
- K192556 — Carnation Ambulatory Monitor
- K192566 — Reach and CQ'ENCE Circular Staplers
- K190486 — Pitkar External Fixation System
- K190953 — Arthrex Minimally Invasive Ankle Fusion Plate
- K191493 — Ventripoint Medical System Plus (VMS+) 3.0
- K191771 — SECURE Screw
- K192250 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
- K192512 — Focus 35C Detector, Trimax 35C Detector
- K192541 — DigiX FDX
- K190149 — Vial Adapter Ø20 mm
- K190840 — Medtronic Transportation / Sterilization Cassettes
- K191251 — Infared Thermometer
- K191326 — Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module
- K191672 — NuFACE Mini Device
- K192194 — TotalShield II Surgical Helmet System
- K192434 — DualX Lumbar Intervertebral Body Fusion Device
- K190937 — Echelon Endopath Staple Line Reinforcement
- K183589 — PMT Facet Screw
- K183674 — Electronic Pulse Stimulator
- K183681 — Protego Antimicrobial Wound Dressing
- K190084 — McLean-Ring Enteral Feeding Tube Set
- K190713 — F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
- K191181 — NXPRO Neuromuscular Electrical Stimulation Device
- K191208 — Spectra Cashmere
- K191420 — Reusable SpO2 Sensor
- K191480 — Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
- K191542 — Apyx Plasma/RF Handpiece
- K191548 — Nexus Universal Self-Cure
- K191684 — MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
- K191822 — Nano FortiCore, FortiCore
- K191902 — Razor, Everest, U&C Liquid
- K192057 — K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall
- K192214 — CarboClear VBR System
- K192235 — AEON Laparoscopic Instruments
- K192312 — Zimmer Natural Nail System Cephalomedullary Nails
- K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
- DEN190025 — OraQuick Ebola Rapid Antigen Test
- K182136 — Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
- K182184 — Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
- K190319 — Waterlase Laser System Family
- K190386 — KTA Adipose Treatment Kit
- K190523 — Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial
- K190772 — SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
- K191010 — Palladium High Flow Therapy System
- K191174 — Mercy babyTAPE
- K191417 — Belun Ring
- K191458 — Legacy SMARTBase Abutments
- K191659 — Instylla Delivery Kit
- K191963 — SMR Finned Short Stems
- K192147 — Halyard ONE-STEP* Sterilization Wrap
- K192210 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
- K192465 — DigiFix Sterile Kit
- K192474 — VERA
- K192526 — Spine Wave Navigated Instruments
- K182448 — AnyRidge Octa 1 Implant System
- K190314 — Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
- K190321 — Pediatric Nailing PlatformFemur
- K190630 — SolidAIRity III Airway Stabilization System
- K191359 — Nipro Syringe
- K191523 — Visalys Restorative Primer
- K191596 — Arcadia Balloon Catheter
- K191687 — pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
- K191783 — Parcus Synd-EZ Ti
- K192185 — The Cellfina System
- K192200 — DynaCAD
- K192208 — CORNICE Cervical Spacer System
- K182773 — Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps
- K183171 — ScopeSeal Duodenoscope Protective Device
- K191127 — Advanced Intermezzo Implant System
- K191133 — KATANA Cleaner, KATANA Cleaner (Trial)
- K191150 — Bodycad Unicompartmental Knee System
- K191369 — TSolution One Total Knee Application
- K191448 — Barrier Sleeves
- K191779 — Attune Revision LPS Inserts
- K191854 — Premia Spine XL Instruments
- K192206 — 32mm Glenosphere and Humeral Cup
- K190086 — Cepheid Xpert Respiratory Control Panel
- K190538 — NIO-I
- K191431 — Interlude Rolled Tampons in Plastic Applicator
- K191632 — PROFEMUR TL2 Stems
- K191833 — Dexcom G6 Pro Continuous Glucose Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.