FDA 510(k) clearances — page 102
clearances on record, most recent first.
Clearances — page 102
10,101–10,200 of 175,620- K222790 — F65 Laser System
- K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
- K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
- K223291 — Electronic Blood Pressure Monitor
- K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
- K230731 — Zavation ALIF System
- K230761 — TRIGEN META-NAIL Nail System
- K231406 — ClearumTM HS
- K201153 — Tisuthes e-PTFE Surgical Patch
- K223517 — Clear Aligner
- K223518 — iOrtho
- K230112 — CAC Software
- K230567 — OptiVu ROSA® MxR
- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
- K231145 — Axis Anterior Cervical Plate System
- K213754 — SpiroHome Personal, SpiroHome Clinic
- K221888 — Genadyne Hybrid Foam Dressings
- K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil)
- K223669 — SecurePortIV Advanced Catheter Securement Adhesive
- K230397 — Cut Screw - Percutaneous Compression Screw
- K231022 — Pounce Thrombectomy System
- K231466 — RxSight Insertion Device
- K223361 — BMR 1900 PHISIO
- DEN220078 — Eroxon
- K220498 — NovoGen Wound Matrix
- K222450 — LVIS NeuroMatch
- K223091 — CT Perfusion V1.0
- K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
- K230293 — TheraFace Mask
- K230502 — Ear Pressure Relief Device(Model:ER813B)
- K230505 — Orthopantomograph OP 3D LX
- K230512 — Gamma4 System
- K230586 — Renuvion® Micro Handpiece
- K230709 — Auryon Atherectomy System
- K230728 — JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
- K230744 — Acumed Acutrak 3 Headless Compression Screw System
- K230768 — M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
- K230776 — Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
- K230779 — Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K230892 — Fixone Biocomposite Anchor
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.