FDA 510(k) clearances — page 237
clearances on record, most recent first.
Clearances — page 237
23,601–23,700 of 175,699- K182367 — DIASAFEplusUS
- K182635 — Signal Catheter
- K182636 — DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
- K182727 — Trident HD Specimen Radiography System
- K182873 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
- K183011 — Additive Orthopaedics Patient Specific 3D Locking Lattice Plates
- K183071 — VLIFT-s Vertebral Body Replacement System
- K183097 — Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
- K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
- K181047 — Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
- K181086 — Cortical Fixation Systems
- K181118 — Reliance Lumbar IBF System
- K181282 — G3A 40 Bone Cement
- K181637 — DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
- K182846 — PENTAX Medical EPK-3000 Video Imaging System
- K182869 — Fit SA
- K183133 — MRCP+ v1.0
- K183200 — iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
- K183422 — Wireless Digital Flat Panel Detector
- K183713 — Wireless Digital Flat Detector
- K180648 — Park Dental Research Aligners
- K182439 — TruShot with Y-Knot Shallow All-Suture Anchor
- K182630 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System
- K182632 — HS30 Diagnostic Ultrasound System
- K182692 — BD MAX CTGCTV2, BD MAX System
- K182721 — Choice Spine Navigation System
- K182868 — INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
- K180564 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
- K182114 — FlareHawk Interbody Fusion System
- K182210 — TiWAVE-L Porous Titanium Lumbar Cage
- K182305 — Stryker Facial iD Plating System
- K183470 — Precision Ideal Eyes Arthroscopes
- K180199 — BIO-C TEMP
- K180477 — Straumann PURE Ceramic Implant System
- K181053 — Care Orchestrator
- K181461 — Rapid-i Kit
- K182621 — CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver
- K182675 — Polygon Resection Device
- K182982 — BridalVeil Navigated Instruments
- K183033 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
- K183175 — BostonSight Scleral
- K183256 — GlideScope BFlex Single-Use Bronchoscope System
- K183293 — VERIFY VH202 Indicator Tape
- K183295 — Celerity HP Chemical Indicator (CI)
- K183392 — PicoLO Nd:YAG Picosecond Laser System
- K180139 — Safe Secure Sterilization Pouches and Rolls
- K180435 — Arm Blood Pressure Monitor
- K180951 — Responsive Arthroscopy Suture Anchor System
- K180983 — Maxcon Two Gallon Chemotherapy Container
- K180984 — Maxcon Sharps Container
- K181127 — EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
- K182568 — V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
- K182741 — SculpSure
- K182766 — Cufitec Surgical Mask
- K183143 — uCT 520, uCT 528
- K183214 — Raven Lumbar Plate System
- K183294 — CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
- K183297 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K183300 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
- K183301 — PRO-LITE Sterilization Tray
- K183643 — Clear Image Aligners
- K181215 — Infrared Thermometer
- K181737 — Raycell MK1
- K181864 — Polaris RF Ablation System
- K182025 — ClearUP Sinus Pain Relief
- K182199 — NFC-700 non-mydriatic auto fundus camera
- K182855 — ProKnow DS
- K183352 — Optimus Neuro System
- K183476 — 3M Filtek Universal Restorative
- K183542 — Signature Orthodontic System
- K183101 — Zenition 50
- K183000 — ViperCath XC Peripheral Exchange Catheter
- DEN170091 — EyeBOX
- K180204 — CranioMaxillofacial Fixation (CMF) System - CMF Visionare
- K180867 — AmCAD-UO
- K181703 — Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
- K182736 — OIC Suture Anchor System
- K183369 — COR12 ECG
- K182045 — Lotus III Multi-Pulsed Er: Yag Laser System
- K182130 — iSchemaView RAPID
- K182404 — STERRAD VELOCITY Biological Indicator
- K182461 — LATITUDE EV Total Elbow Arthroplasty
- K182564 — Quantib ND
- K182845 — minisono
- K183169 — Pulse 2.0, Pulse Pro 2.0
- K181761 — Zimmer Biomet Select Ceramic Heads
- K182099 — Delta TT Pro
- K182242 — VO200 NeurOs Cerebral Oximetry System
- K182698 — LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
- K182709 — One-Step Suprapubic Introducer
- K182783 — DePuy Synthes Trauma Orthopedic Nail Implants
- K181641 — QuikClot Radial
- K183007 — EliA SmDP Immunoassay
- DEN170070 — MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit
- DEN180007 — Miris Human Milk Analyzer
- K173036 — North-vision Multi-parameter Patient Monitor
- K173747 — REXLENE
- K180014 — Creme de La Femme Feminine Lubricant
- K180380 — vital signs monitor
- K180821 — TruMatch Graft Cage - Long Bone
Data sourced from openFDA. This site is unofficial and independent of the FDA.