FDA 510(k) clearances — page 236
clearances on record, most recent first.
Clearances — page 236
23,501–23,600 of 175,699- K181956 — Masimo MightySat Rx Fingertip Pulse Oximeter
- K182907 — SPY Elite Intraoperative Perfusion Assessment System
- K183151 — Optilite IgA CSF Kit
- K180767 — FEMON Banana Thermometer
- K181887 — AMD Anti-Fog Solution
- K182193 — S-Line
- K182574 — Freedom Ultra-Congruent CR Tibial Liner
- K182837 — M.U.S.T. Mini Extension
- K182894 — HM70A Diagnostic Ultrasound System
- K182955 — EZStart Interference Screw
- K182970 — EUROPA Pedicle Screw System
- K183553 — Compress and Mini Compress Anti-Rotation Spindles
- K183636 — SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
- K183671 — LG PRA.L DERMA LED MASK
- K183685 — O-Scan
- K182507 — Tigon Medical Tissue Anchors
- K183357 — XableCath Crossing Catheter
- K183581 — Codman Disposable Perforators
- K182527 — ELAN 4 Tools
- K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
- K181076 — Responsive Arthroscopy Wedge Push-In Suture Anchors
- K181084 — PENTAX Video Colonoscopes (EC Family)
- K181097 — Cook Cystostomy Catheter Set
- K181099 — Bright Guard
- K181126 — Reprocessed Visions PV .035 Digital IVUS Catheter
- K181895 — Kurin PIV Blood Collection Set with High Pressure
- K182211 — Aurora Surgiscope System
- K182284 — Tyber Medical PT Interbody Spacer
- K182323 — PICO 7Y Single Use Negative Pressure Wound Therapy System
- K182518 — AHMED ClearPath Glaucoma Drainage Device
- K182620 — MRI Compatibility for Existing Neodent Implant System
- K182782 — DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
- K182784 — MUTYH-Associated Polyposis (MAP)
- K182951 — Pristina Serena 3D
- K182956 — Puffin Lite Infant Resuscitation System
- K183224 — SureForm 45, SureForm 45 Reloads
- K183231 — SIGNA Premier
- K183254 — Magnetom Vida
- K183264 — Flex-THOR scope
- K183298 — HardyDisk AST Omadacycline 30µg (OMC30)
- K180779 — Savina 300
- K181190 — Pinehurst Anterior Cervical Plate System
- K181302 — Bodycad Unicompartmental Knee System
- K181338 — Imboki Knee Instrument System
- K182010 — ProgenaMatrix
- K182111 — DL Self-adhesive Electrode
- K182227 — Esprit Nova
- K182456 — Study Watch
- K183060 — CervAlign Anterior Cervical Plate System
- K183538 — VIVA combo RF System
- K173847 — Disposable Ultra Reinforced Surgical Gown
- K180410 — Dosis SAM
- K181071 — SIRA RFA Electrosurgical Device
- K181106 — Powder Free Nitrile Patient Examination Gloves, Blue Color
- K181451 — URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
- K181540 — Estremo Citieffe Nailing System
- K182489 — 4CIS® Pinehurst Anterior Cervical Plate system
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.