FDA 510(k) clearances — page 245
clearances on record, most recent first.
Clearances — page 245
24,401–24,500 of 176,542- K182538 — Merit RadialFlo Arterial Catheter
- K182651 — HbA1c Advanced
- K183165 — Pristine Scope
- K183329 — Laser Hair Therapy
- K183474 — Carestream DRX-1 System with DRX Core Detectors
- K183510 — T2 STRATOSPHERE Expandable Corpectomy System
- K181096 — Avenue P Cage System
- K182478 — Whistler Modular Pedicle Screw System
- K182497 — OsteoCool RF Ablation System
- K183497 — JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
- K180570 — Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
- K182307 — Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System
- K182898 — TenoTac Soft Tissue Fixation System
- K183514 — ZELTIQ CoolSculpting System
- K180228 — II-Type Intervertebral Spacer
- K180229 — RESCAN 700, CALLISTO eye
- K180902 — MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
- K181377 — PROSTEP MICA Screw System
- K181649 — AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
- K181805 — UV Phototherapy
- K181917 — MTA2.3 MATERIALS
- K182202 — SLEEPAPP
- K182212 — Geo Staple System
- K182409 — Applied Tissue Technologies PWD Platform Wound Dressing
- K182421 — Senhance Ultrasonic System
- K182453 — ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)
- K182500 — Catalyst CSR Press-Fit Humeral Components
- K182517 — MULTIX Impact
- K182545 — Tamper Evident Cap with Male Luer Lock
- K182928 — CD Horizon Spinal System
- K182973 — DigitalDiagnost C90
- K183031 — ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
- K183137 — uMR 580, uMR 588
- K183140 — MTS Tetracycline 0.016 - 256 ug/mL
- K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable
- K183467 — Roadrunner Extra Support Wire Guide
- K180355 — Advocate Non-Contact Infrared Thermometer
- K180387 — Infrared Ear Thermometer
- K180837 — CONTEC Oxygen Concentrator
- K181180 — OSSIO Pin Product Family
- K181204 — RENASYS Y-Connector; RENASYS TOUCH
- K181444 — CLARUS
- K182120 — Maxpower Relief
- K182367 — DIASAFEplusUS
- K182635 — Signal Catheter
- K182636 — DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
- K182727 — Trident HD Specimen Radiography System
- K182873 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
- K183011 — Additive Orthopaedics Patient Specific 3D Locking Lattice Plates
- K183071 — VLIFT-s Vertebral Body Replacement System
- K183097 — Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
- K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
- K181047 — Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
- K181086 — Cortical Fixation Systems
- K181118 — Reliance Lumbar IBF System
- K181282 — G3A 40 Bone Cement
- K181637 — DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
- K182846 — PENTAX Medical EPK-3000 Video Imaging System
- K182869 — Fit SA
- K183133 — MRCP+ v1.0
- K183200 — iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
- K183422 — Wireless Digital Flat Panel Detector
- K183713 — Wireless Digital Flat Detector
- K180648 — Park Dental Research Aligners
- K182439 — TruShot with Y-Knot Shallow All-Suture Anchor
- K182630 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System
- K182632 — HS30 Diagnostic Ultrasound System
- K182692 — BD MAX CTGCTV2, BD MAX System
- K182721 — Choice Spine Navigation System
- K182868 — INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
- K180564 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
- K182114 — FlareHawk Interbody Fusion System
- K182210 — TiWAVE-L Porous Titanium Lumbar Cage
- K182305 — Stryker Facial iD Plating System
- K183470 — Precision Ideal Eyes Arthroscopes
- K180199 — BIO-C TEMP
- K180477 — Straumann PURE Ceramic Implant System
- K181053 — Care Orchestrator
- K181461 — Rapid-i Kit
- K182621 — CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver
- K182675 — Polygon Resection Device
- K182982 — BridalVeil Navigated Instruments
- K183033 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
- K183175 — BostonSight Scleral
- K183256 — GlideScope BFlex Single-Use Bronchoscope System
- K183293 — VERIFY VH202 Indicator Tape
- K183295 — Celerity HP Chemical Indicator (CI)
- K183392 — PicoLO Nd:YAG Picosecond Laser System
- K180139 — Safe Secure Sterilization Pouches and Rolls
- K180435 — Arm Blood Pressure Monitor
- K180951 — Responsive Arthroscopy Suture Anchor System
- K180983 — Maxcon Two Gallon Chemotherapy Container
- K180984 — Maxcon Sharps Container
- K181127 — EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
- K182568 — V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
- K182741 — SculpSure
- K182766 — Cufitec Surgical Mask
- K183143 — uCT 520, uCT 528
- K183214 — Raven Lumbar Plate System
- K183294 — CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
Data sourced from openFDA. This site is unofficial and independent of the FDA.