FDA 510(k) clearances — page 105
clearances on record, most recent first.
Clearances — page 105
10,401–10,500 of 175,620- K231224 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
- K220721 — FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
- K222501 — Regeneten Bioinductive Implant
- K222549 — OpenTex
- K223265 — CryoX Vitrification Freeze Kit / Thaw Kit
- K223623 — SubtleMR (2.3.x)
- K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
- K230550 — JAWS Nitinol Staple System
- K231052 — ExacTrac Dynamic 1.1.2
- K220437 — Neurophet AQUA
- K221127 — Sientra, inc. Portfinder
- K222870 — Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
- K222987 — Akunah REFLECT
- K223044 — Digital Thermometer (Model QT001)
- K223318 — Internal Joint Stabilizer - Elbow
- K223624 — Emerald Herbst
- K230491 — HandX Monopolar Scissors
- K231032 — AMP by Method Mobility, AMP Plus (or +) by Method Mobility
- K231338 — 3M Clinpro Clear 2.1% Sodium Fluoride Treatment
- DEN220083 — Stanza
- K212857 — Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
- K222436 — Latitud Hip Replacement System
- K222484 — Retitrack
- K222719 — CX50N
- K223015 — STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette
- K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- K223025 — Tyvek Roll with CI for STERLINK Sterilizer
- K223335 — SIRION Lateral Lumbar Interbody System
- K223655 — Catalyst R1 Reverse Shoulder System
- K223825 — Tens & Ems Device
- K230721 — ATEC Lateral Plate System
- K222487 — Anika Tissue Tack Fixation System
- K222716 — MX50N
- K223280 — Disposible Nitrile Gloves
- K223428 — Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
- K230674 — JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
- DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
- DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
- K202963 — ELEC Master, ELEC Master Dual
- K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
- K221768 — Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
- K222926 — Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
- K223858 — Lexa MINI (RIS-303, RIS-305)
- K230351 — LED Facial Mask
- K230615 — Electric Scooter (Model: S3312)
- K230616 — Polyguard and Polyshield Safety IV Catheters
- K230637 — Wattson temporary pacing guidewire (2250)
- K230989 — Rod Registration Frame
- K231017 — Panther Fusion AdV/hMPV/RV Assay
- K203245 — Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
- K213280 — BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
- K220290 — Revitalair 430+
- K220322 — Pollogen STOP U Model UXV Device
- K220713 — Sol-Guard Auto-disable Syringe
- K221798 — Finger Pulse Oximeter, Model: X1906P
- K222097 — OLYMPIC Deformity Band System
- K222388 — swiftPro System
- K222847 — Ceramic Brackets Orthometric
- K223430 — ProLift Micro Expandable Spacer System
- K223756 — SimPro Now, GentleCath Hydrophilic
- K223771 — Lumify Diagnostic Ultrasound System
- K223805 — Agnes
- K230082 — Auto Segmentation
- K230266 — Orchid Safety Release Valve
- K230340 — Lucas Plus
- K230530 — SOZO Pro
- K230531 — SOZO Pro
- K230619 — Hubly Electric Drill (H100)
- K230653 — Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates
- K230960 — DLP Silicone Coronary Artery Ostial Cannulae
- K230994 — Alinity i STAT High Sensitivity Troponin-I
- K212743 — MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
- K222421 — Sphincterotome
- K223758 — Epione
- K223843 — FloPatch FP120
- K230123 — Apollo Knotless Suture Anchor
- K230203 — Dentis I-FIX Abutment
- K230655 — PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
- K230934 — ViewFlex Eco Reprocessed ICE Catheter
- K230938 — ARIX Humerus System
- K230948 — BFlex 2 Slim 3.8 Single-Use Bronchoscope
- K212579 — FortiShield (Biosynthetic Wound Matrix)
- K221779 — ASEPT Peritoneal Drainage System
- K223495 — Zeolite Hemostatic Cotton
- K223511 — Excella Navigation Instruments
- K223529 — PressON Spinal Fixation System
- K223907 — NuEra Tight RF Model APMD145.M70-US
- K230119 — 3D Anatomic Model
- K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
- K230606 — AcQMap® High Resolution Imaging and Mapping System
- K230614 — Cortium
- K230880 — CoreLink Navigation Instruments
- K230912 — Artix BG
- K230957 — TriSalus TriNav® LV Infusion System
- K230977 — SIS System
- K221870 — CarnaLife Holo
- K222416 — RIA Safeguard
- K223182 — Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy
- K223595 — vPATCH
- K230643 — CP620G LCD monitor, CP620 LCD monitor
Data sourced from openFDA. This site is unofficial and independent of the FDA.