FDA 510(k) clearances — page 98
clearances on record, most recent first.
Clearances — page 98
9,701–9,800 of 175,620- K231589 — Blood Tubing Lines for Hemodialysis AV06C-E
- K231618 — 3 Layer Surgical Mask (134252531)
- K231931 — Adena-Zina Spinal System
- K231951 — SI-Cure Sacroiliac Joint Fusion System
- K212077 — Teleflex Rusch SoftSimplastic Foley Catheters
- K223591 — cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
- K230074 — Rapid Aneurysm Triage and Notification
- K230838 — Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
- K231044 — R2P Navicross
- K231195 — Brainomix 360 Triage ICH
- K231221 — MDx-Chex for BC-GP
- K231223 — MDx-Chex for BC-GN
- K231236 — IBS-B MIS Beveled Screw System
- K231261 — Altaviz Needle Kit II
- K231555 — LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
- K231886 — SURGIVISIO Device
- K231912 — Therm-X
- K220765 — HS Fiber Cerclage
- K222874 — CarboClear Cervical Cage System, CarboClear Cervical VBR System
- K222994 — Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
- K231038 — Global Hypoperfusion Index (GHI) Algorithm
- K231172 — ApolloKnee
- K231572 — uMI Panorama
- K231787 — ecoFIX®
- K231922 — DEPUY SYNTHES MAXFRAME AUTOSTRUT System
- K213536 — DEKA ACE Pump System
- K221605 — Emit® II Plus Buprenorphine Assay
- K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl)
- K223473 — ME-APDS; MAGENTIQ-COLO
- K230365 — Sonio Detect
- K230455 — Enamel Coating Resin
- K230540 — Patient Specific Planning Solution 3D Bone Models
- K230576 — IDENTIFY
- K230730 — Apyx
- K230913 — ANDI
- K231275 — Exceed Biplanar Expandable Interbody System
- K231577 — MOBILETT Impact
- K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031)
- K231878 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
- K231900 — A-TAP (previously called Arthrotap)
- K231924 — EZ-IO Intraosseous Vascular Access System
- K223322 — Argus Cognitive ReVISION Software
- K223347 — UltraSight AI Guidance
- K223752 — Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
- K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
- K231523 — EsCom250
- K230931 — Atlan
- K211218 — BD Alaris System with Guardrails Suite MX v12.1.2
- K221319 — BD Alaris Pump Epidural Infusion Set
- K221327 — BD Alaris Pump Infusion Sets
- K223037 — Infrared Thermometer, Model: IR8807
- K223189 — Firefighter NC Pro PTCA Balloon Catheter
- K223288 — Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
- K223316 — Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
- K223317 — Alkaline Phosphatase2
- K223499 — Three Way Stop Cock
- K223637 — Elecsys proBNP II, Elecsys proBNP II STAT
- K223769 — NextAR Spine Platform
- K230150 — OptimMRI
- K230560 — enspire 300 Series Automated Endoscope Reprocessor System
- K231021 — KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe
- K231173 — Irregular Rhythm Notification Feature (IRNF)
- K231474 — Erchonia Violet ZERONA® Z6 OTC
- K231483 — MySpine Unilateral Guides
- K231516 — INHANCE Shoulder System, Sterile Single Use Instrumentation
- K231848 — Triever20 Curve (21-201)
- K231861 — EndoflipTM 300 System
- K231862 — TruDi® Navigation System V3 (FG-2000-00)
- K213098 — Panther 5
- K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
- K222920 — Oxygen concentrator
- K223301 — ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
- K223484 — IGAR System (1001.A)
- K223834 — AccuCheck
- K230039 — uOmnispace
- K230377 — CROSSLEAD Penetration Peripheral Guide Wire
- K230787 — Oscar 15 & Oscar 15i
- K230875 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
- K231103 — ROSA ONE Brain Application
- K231790 — The InMode System with the Morpheus8 Applicators
- K231799 — INERTIA® CONNEXX Modular Pedicle Screw System
- K231808 — QUASAR Standalone ACIF System
- K231840 — CastleLoc-S Posterior Cervical Fixation System
- K231945 — VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
- DEN220047 — Galen ES Cooperative Surgical Assistant Platform, Galen ES
- K210801 — AXINON® LDL-p Test System
- K223151 — Nu-beca Transcutaneous Electrical Nerve Stimulation
- K230037 — BACK 3
- K231157 — syngo.CT Lung CAD (Version VD30)
- K231292 — TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System
- K231410 — RenaPure Endotoxin Retentive Filter
- K231437 — LF900
- K231448 — TANDEM Hip System
- K231472 — Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
- K231796 — Grreen X 12 (Model: PHT-75CHS)
- K231839 — CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
- K213100 — FMT Reusable Temperature Probes
- K221107 — TRUST
- K222925 — Hypodermic Syringes & Needle
Data sourced from openFDA. This site is unofficial and independent of the FDA.