FDA 510(k) clearances — page 355
clearances on record, most recent first.
Clearances — page 355
35,401–35,500 of 176,542- K142577 — PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
- K142645 — Avenue T TLIF Cage
- K143559 — XP1000 RF
- K150135 — DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
- K150216 — Synergy Cranial
- K150250 — SternSnap Angled Attachment
- K150280 — PulmoVia Working Channel
- K150362 — NuVasive CoRoent Small Interbody System
- K150373 — Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]
- K150489 — EOS PMP, EOS PMP Integrated
- K150548 — Tek RMD (Tek Robotic Mobilization Device)
- K151244 — Pre-Formed Guidewire
- K142920 — KM Needles (Acupuncture Needle)
- K143572 — Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
- K143730 — GBR System
- K150569 — LaparoVue
- K150867 — Affixus Tibial Nailing System
- K151253 — 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
- K151260 — ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
- K151291 — BD Veritor (TM) System for the Rapid Detection of Flu A+B
- K141292 — Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System
- K142269 — Reliance Cervical IBF System
- K142559 — ELEVATE Spinal System
- K142770 — Powered Wheelchair
- K142906 — APTUS Wrist 2.5 System
- K143520 — SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)
- K150034 — AMT Enteral Transition Adapters
- K150393 — TETRIC EVOFLOW BULK FILL
- K150578 — Capillus 272 Office Pro
- K150593 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
- K150625 — Morrison Steerable Needle
- K150662 — Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
- K150753 — OASYS System
- K151240 — extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
- K132058 — VIDAS FT4
- K142327 — smARTrack Feeding Tube System
- K143466 — Hemogrip Patch
- K150466 — ZX2 Laser System
- K150643 — Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
- K150725 — Visaris Avanse
- K150939 — Ensizor Endoscopic Scissors
- K151301 — BD Veritor System Flu A+B Assay
- K151082 — MicroCross Catheter
- DEN130033 — COGNIVUE
- K140021 — TI-OSS
- K142503 — IMED-Z FLUID STATUS MONITOR
- K142518 — HumaPen Luxura
- K143002 — Metallic Locking Bone Plate and Screw System
- K143380 — Phasix ST Mesh
- K143715 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K150109 — Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
- K150140 — MCL 31 Dermablate
- K150186 — Chariot Guiding Sheath
- K150294 — DPZ Pedicular Fixation System
- K150332 — FreeStyle Lite Blood Glucose Monitoring System
- K150517 — Freedom Spinal Cord Stimulator System
- K150531 — FreeStyle Freedom Lite Blood Glucose Monitoring System
- K150761 — Ez3D-i/E3
- K151001 — MUSE System
- K151060 — Ultrasound System SONIMAGE HS1
- K151203 — Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
- K142446 — Fixtemp Cement
- K142595 — VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
- K142833 — INTRAGen
- K143041 — Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
- K143570 — WIRION
- K143590 — Alevicyn SG Antipruritic Gel
- K150012 — CreoDent Solidex Customized Abutment
- K150266 — Remington Medical Inc. Tuohy Epidural Needles
- K150443 — ToeTac Hammertoe Fixation System
- K150472 — NxStage System One
- K150552 — ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
- K150581 — Tritium Sternal Cable Plate System
- K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System
- K150976 — Collage
- K151211 — AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
- K141637 — SPB SKIN EMULSION
- K142159 — DISPOSABLE PRE-GELLED SURFACE ELECTRODE
- K143204 — AOS Clavicle Intramedullary Device
- K143387 — GE333 Blood Glucose Monitoring System
- K143432 — Cardio-TriTest
- K150093 — Pulse Oximeter, Models PC-66A +16 more
- K150570 — ANAX OCT Spinal System
- K150910 — ACCU-CHEK Connect Diabetes Management App
- K150949 — FibroScan
- K151115 — MR Core Software
- K151215 — Mercury Spinal System
- K141188 — MICRODENT GENIUS IMPLANT SYSTEM
- K142794 — Everyway Facial MENS
- K143524 — Fiber Disks and Blocks (TRINIA)
- K150042 — PleuraFlow System
- K150076 — Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
- K150434 — Injection Needle
- K150562 — Safe'n'Sound Staked Passive Delivery System - Plajex version
- K141531 — POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
- K143086 — VX120 Ophthalmic Diagnostic Device
- K143335 — Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
- K143397 — ICIS View
- K150549 — Reactor(TM) Trocar and Sleeve
- K150617 — cobas HSV 1 and 2 Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.