FDA 510(k) clearances — page 253
clearances on record, most recent first.
Clearances — page 253
25,201–25,300 of 176,542- K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe
- K182614 — RCT700
- K180418 — Reliant(TM) Multistage Dilatation Balloon Catheter
- K181815 — DynaBridge
- K181910 — BracePaste MTP Light Cure Primer
- K182036 — NeuroBlate System
- K182233 — FlowTriever Retrieval/Aspiration System
- K180099 — Optilite High Sensitivity C-Reactive Protein Kit
- K180292 — PENTAX Video Upper G.I. Scope EG34-i10
- K180446 — b-ONE Total Knee System
- K180620 — Endophys Pressure Sensing Sheath Kit
- K180991 — AG 100s
- K181220 — Juell 3D Volo Base
- K181539 — OSSDSIGN Cranioplug
- K181569 — BKS Revision Sleeves System
- K181607 — Thorecon Rigid Fixation System
- K181640 — X-BOLT Hip Fracture Fixation System
- K181644 — EIT Cellular Titanium® Lumbar Cage LLIF
- K181651 — Radial Medical Compression System
- K181717 — Life Spine Laminoplasty System
- K181848 — ADAPT for Gamma3, Gamma3
- K181852 — Percuvance Percutaneous Surgical System
- K181999 — Integra TITAN Reverse Shoulder System
- K182129 — MAGNETOM Sola
- K182237 — uMI 550 PET/CT System
- K182247 — ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
- K182504 — 3.0T Air MP M, 3.0T Air MP L
- K182522 — Penumbra System (Modified 110 Aspiration Tubing)
- K182536 — Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
- K173920 — LS OIL
- K180249 — OmniPore DUROMAX Surgical Implants
- K180555 — Ergoline Prestige 1600 Hybrid Performance
- K180680 — Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
- K180872 — SCARLET SRF
- K181008 — NuFACE Trinity
- K181091 — AxSOS 3 Ti
- K181330 — NeoMatriX Wound Matrix
- K181426 — Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
- K181460 — OnePacs System
- K181503 — Fingertip Pulse Oximeter
- K181520 — Sirona Dental CAD/CAM System
- K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture
- K181617 — E-CUBE 8
- K182015 — Piccolo Composite® Plate System
- K182151 — MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
- K182244 — Voyant Electrosurgical Generator
- K182826 — Ormco Spark Aligner System
- K172826 — Cellent Spinal Systems
- K173194 — Temperature Probe
- K180467 — SBG Blue Nitrile Powder Free Medical Examination Glove
- K180468 — SBG Black Nitrile Powder Free Medical Examination Glove
- K181038 — CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
- K181774 — Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures +4 more
- K181863 — Elvie Pump
- K182070 — BioHorizons Tapered IM Implants
- K182289 — Sterile High-pressure Angiographic Syringes for Single-use
- K182492 — Geminus Volar Distal Radius Plate System
- K182531 — ClotTriever Thrombectomy System
- K181517 — Senhance Surgical System
- K181818 — Scarlet AL-T
- K181892 — Ziostation2
- K182490 — Swiss LithoClast Trilogy
- K182018 — Bluetooth blood pressure monitor
- K182117 — Vinyl Patient Examination Gloves
- DEN180026 — Bose Hearing Aid
- K173945 — Straumann SC Variobase Abutments
- K180054 — Royal Flush Plus High-Flow Catheter
- K180919 — GORE Tri-Lumen Catheter
- K181322 — MAGNETOM Sola
- K181531 — SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
- K181587 — ORTHOLOC SPS Shoulder Plating System
- K181603 — EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
- K181642 — B-Laser Atherectomy System
- K181725 — Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
- K181860 — NuVasive Cohere Thoracolumbar Interbody System
- K181868 — SHINY RPL System
- K182112 — Sense System with IBT Electrodes
- K173076 — CURA 16; ScintCare CT16
- K180209 — Diazyme 1,5-AG Assay
- K180736 — WishBone Medical Plate and Screw System
- K181240 — Rhino-Laryngo Fiberscope Olympus ENF-GP2
- K181949 — SYMPHONY OCT System
- K182059 — Prase MIS Spinal System
- K182122 — Ureteric Catheters
- K182189 — Encompass SRS Headframe; Encompass MR SRS Headframe
- K182337 — HYBRID Guidewire
- K182423 — MAGLUMI 2000 FT4
- K182436 — POWEREASE System
- K182533 — PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
- K180972 — ARIX Clavicle System
- K181138 — IS-III active System
- K181196 — Caretaker Remote Display App and Caretaker Software Library
- K181370 — uMR 780
- K181371 — uMR 790
- K181527 — On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
- K181881 — Outlet Sacroiliac Joint Fusion System
- K181883 — FIREFLY® Midline Navigation Guide
- K181903 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
- K182050 — Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch
- K182115 — Vinyl Patient Examination Gloves
Data sourced from openFDA. This site is unofficial and independent of the FDA.