FDA 510(k) clearances — page 244
clearances on record, most recent first.
Clearances — page 244
24,301–24,400 of 176,542- K183070 — ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
- K173743 — Greenmedi Safety Filter Syringe
- K180822 — VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
- K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
- K181775 — Quantum Blood and IV Fluid Infusion Warmer
- K182093 — ZOLL ECG Analysis Software
- K182228 — MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
- K182477 — Cervical Spacer
- K183001 — WEGO-PGLA RAPID
- K183004 — WEGO-PGA RAPID
- K183025 — MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
- K183362 — Venue GO
- K183456 — Aloka Arietta 850
- K180230 — NEST Interbody System
- K180780 — microINR System
- K182078 — MiniCollect K2E K2EDTA Tubes
- K182389 — Sysmex XN-L Automated Hematology Analyzer
- K182480 — Earlens Contact Hearing Aid
- K182548 — Accucuff Cuff Pressure Indicator
- K182642 — GenesisZr 4Y Zirconia
- K182895 — Wilson-Cook Achalasia Balloon
- K182919 — SI-Restore® Sacroiliac Joint Fixation System
- K182968 — Hoffmann LRF System
- K183042 — SMR Lateralized Connectors with screws
- K183228 — HammerToe Compression System
- K183321 — Treace Medical Concepts (TMC) Plating System
- K183468 — Revive Reusable Bladder Support
- K183615 — Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
- K183631 — medi pneumatic compression system (pcs) brio (Model 651)
- K180183 — Ritter Dental Implant System
- K181056 — Reprocessed CS Diagnostic Electrophysiology Catheter
- K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
- K182297 — Surveyor S2
- K182312 — Zyppah Anti-Snoring Device
- K182363 — BTL-703
- K182514 — Surgical Face Mask
- K182594 — E-CUBE i7
- K182964 — ROSA Knee System
- K183244 — MAGNETOM Lumina
- K183346 — FLOW 90 Wand
- K183541 — ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
- DEN180047 — Aptima Mycoplasma genitalium Assay
- K181387 — Pre-Formed Penile Silicone Block
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.