FDA 510(k) clearances — page 111
clearances on record, most recent first.
Clearances — page 111
11,001–11,100 of 176,479- K230905 — OrthoPulse 2.0E (OPi2E-100)
- K230992 — DJF Intravascular Administration Set
- K231037 — MyKnee UNI-ST
- K231347 — BruxZir TintEFX Coloring Liquid
- K231359 — RODIN Expandable Lumbar Cage System
- K231368 — Bemer Therapy System Evo
- K214124 — AlloX2 Pro Tissue Expanders
- K222001 — Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
- K222684 — XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2 Spinal System, ES2 Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi
- K222762 — SIDDHARTH-II; IMPACT
- K222792 — SNUCONE Tissue Level Implant System
- K223918 — AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
- K230008 — Ablamap® System
- K230057 — Acumen Hypotension Prediction Index (HPI) Algorithm
- K230659 — Zionic Aesthetic
- K230715 — Promisemed Safety Huber Needle
- K231042 — Disposable Laparoscopic Trocar
- K231350 — OCD MT Cap (85-00397-000)
- K212183 — STA R Max 3, STA Compact Max 3
- K213611 — Fenom Pro
- K222248 — Infrared Thermometer
- K223059 — Xenco Medical InterAlign Cervical Interbody System
- K230381 — Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
- K230446 — TiLink-L SI Joint Fusion System
- K230572 — AETOS Shoulder System
- K230651 — BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)
- K230691 — HyperVue Imaging System
- K231002 — Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
- K231170 — C350/C350G LCD Monitor; M550/M550G LCD Monitor
- K231322 — Fix2Lock(PEEK Self Punching)
- K231360 — Ambra PACS
- K231430 — Intimate Rose Vaginal Dilators
- DEN220028 — Cue COVID-19 Molecular Test
- K212733 — Diode laser therapy device
- K212734 — Diode laser therapy device
- K220117 — ARC Intensive Care Information System (ARC System)
- K223532 — Olea S.I.A. Neurovascular V1.0
- K223855 — FEops HEARTguideTM, FEops HEARTguideTM ALPACA
- K230005 — Pantheris LV Atherectomy Catheter
- K230261 — Gnesis EMS Plus
- K230329 — F3D Interbody System
- K230584 — Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
- K230660 — AviClear Laser System
- K231349 — Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
- K231635 — A-Line Advanced
- K211618 — Fluido Compact Blood and Fluid Warming System
- K223718 — HandX Self-Righting Needle Holder
- K223801 — FX V135(TM) Shoulder Prosthesis
- K230225 — DynaFlex Clear Brackets & Buttons
- K230498 — ArtiSential Laparoscopic Instruments-Electrodes
- K230633 — APOLLO ADVANTAGE Nitrile Examination Gloves
- K230727 — SPY Portable Handheld Imaging (SPY-PHI) System
- K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track
- K231320 — Zhenjiang Assure Mechanical Wheelchair,model:K1
- K231348 — Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
- K221752 — Stella
- DEN220041 — Tristel Duo ULT
- K220301 — Volumat Line
- K220728 — vWF Ag
- K221801 — ADVIA Centaur® Anti-Müllerian Hormone (AMH)
- K222018 — Breathe+
- K222702 — RGS; RGS Mini
- K222727 — i3 ONE (203100-S); i3 TWO connect (203200-S); i3 TWO direct (203300-S)
- K222961 — Harvest Conceal ZR Block Out
- K223074 — CorNeat EverPatch
- K223562 — Xpan Universal Trocar System
- K223822 — ACTIVBRAID
- K230214 — Huma RPM (RPM)
- K230635 — Pen Needle
- K230888 — Titanium Turbine
- K230936 — Anatomic PEEK Cervical Fusion System with Nanotechnology
- K230952 — Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component
- K230971 — APTUS® 3.5 TriLock Straight Plates
- K231309 — SCAR 3
- K231311 — CPS Direct Universal slittable outer guide catheter (DS2C029)
- K231314 — Fine Osteotomy
- K222905 — Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
- K223299 — Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance
- K223447 — OmniTom Elite
- K223498 — Radius VSM and Accessories
- K223555 — Brainomix 360 e-CTP
- K223676 — SomniCheck
- K223929 — Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)
- K230185 — ANT-X System
- K230408 — K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
- K230617 — Surgical Face Mask (L 175*95mm)
- K230827 — HardyDisk AST Rezafungin 5µg (RZF5)
- K230990 — Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
- K231293 — Drakon and Sequre® Microcatheters
- K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
- K231330 — FiberTak® Suture Anchor
- K211056 — Oxus Sieve Beds
- K213010 — FEELject LDV (Low dead volume) syringe
- K213992 — CombiSet Hemodialysis Blood Tubing Set
- K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
- K222556 — BTL-785X
- K222644 — Nihon Kohden NKV-440 Ventilator System
- K222885 — Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
- K230542 — Disposable Nitrile Gloves (ABC-DG01)
- K230671 — Pitch PaSoft Tissue Reinforcement Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.