FDA 510(k) clearances — page 245
clearances on record, most recent first.
Clearances — page 245
24,401–24,500 of 175,699- 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; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
- 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
- K182539 — 2MP Color LCD Monitor CL-R211
- K171696 — NOxBOXi Nitric Oxide Delivery System
- K173642 — KLOCKNER SURGICAL BOX
- K181081 — Infrared Ear Thermometer
- K181867 — Deka Smartxide2 Trio
- K181885 — Voyant System
- K182051 — FUJIFILM Duodenoscope Model
- K173716 — MPS2 Myocardial Protection System Console
- K181445 — AMSure Hydrophilic Intermittent Catheter
- K181622 — StrataMR guider tool
- DEN170080 — Adaptive Biotechnologies clonoSEQ Assay
- K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System
- K173872 — FibriCheck
- K180041 — BioCode Gastrointestinal Pathogen Panel (GPP)
- K180068 — ORISE Gel
- K180216 — Seidmon Antegrade AQ Stent Set
- K180241 — Orthocaps Twinaligner
- K180964 — Endoscope Sterilization Tray
- K180973 — Libertas Hip Replacement System
- K180998 — BioHorizons CAD/CAM Bars
- K181088 — TSP Crosser Transseptal Access System
- K181124 — Acessa ProVu System
- K181277 — E-CUBE 12
- K181476 — Prime&Bond active Universal Adhesive
- K181652 — Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
- K181746 — MICRORAPTOR Knotless Suture Anchor
- K181771 — RightEye Vision System
- K181794 — Truliant Porous Femoral Components
- K182039 — Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
- K182376 — Harmony
- K182415 — Alphenix, INFX-8000F/B, V8.0
- K173833 — CRP Vario
- K181021 — EmboCube Embolization Gelatin
- K181075 — PureSet Tray
- K181397 — DualX
- K181608 — Disposable Standard Clamp
- K181742 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K181975 — Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
- K182370 — Acculoc Total Knee System
- K182377 — CarboClear® Pedicle Screw System
- K182402 — CoLink View Plating System
- K180340 — Stat Profile Prime Plus Analyzer System
- K180803 — BeautiBond Universal
Data sourced from openFDA. This site is unofficial and independent of the FDA.