FDA 510(k) clearances — page 254
clearances on record, most recent first.
Clearances — page 254
25,301–25,400 of 175,699- K172985 — Ligation Device
- K173376 — ASI Evolution
- K173455 — SurgTech Bipolar Head System
- K173780 — EchoMD Automated Ejection Fraction Software
- K173977 — CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
- K180100 — MRIaudio PREM System
- K180290 — Natus Brain Monitor Amplifier
- K180401 — TiWAVE-C Porous Titanium Cervical Cage
- K180502 — S128 Anterior Lumbar Interbody Fusion (ALIF) System
- K180505 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
- K180719 — InMode Diolaze System
- K180738 — COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
- K180813 — BTL 799-2
- K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System
- K181301 — Smart External Drain (SED) System
- K181316 — POGO Automatic Blood Glucose Monitoring System
- K181351 — Double Flexible Tipped Wire Guides
- K172983 — HealthCCS
- K173259 — Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
- K180565 — PEAK NS033CF, PEAK NS017CF
- K180675 — Atlas Spine Expandable Cervical Interbody System
- K180681 — Aptima Combo 2 Assay (Panther System)
- K180818 — Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
- K180861 — Vinyl Examination Glove (Clear, Non-Colored)
- K180989 — PEDRA-17F Digital Flat Panel X-ray Detector
- K181050 — Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
- K181271 — Signature Orthodontic System
- K181279 — Ysio Max
- K181298 — Harmony XL Multi-Application Platform
- K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels
- K181429 — CELERITY 20 HP Biological Indicator
- K181442 — VERIFY Assert Self-Contained Biological Indicator
- DEN170043 — DreaMed Advisor Pro
- K172783 — Access hs Tnl
- K172823 — Portex NRFit Epidural Needles
- K172831 — Perfusor® Space Syringe Infusion Pump System
- K172833 — E-XPE Acetabular Components and U-Motion II Acetabular Cup
- K180124 — ZQuiet
- K180260 — Powder Free Vinyl Patient Examination Gloves (Yellow, White)
- K180452 — White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
- K181093 — SyMRI
- K181343 — HeartSee Cardiac P.E.T. Processing Software
- K171422 — Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
- K172821 — Ti-one 101 TS Dental Implant System
- K172835 — GRI-Alleset Veress Needle
- K172961 — LIAC HWL
- K173200 — SOFIA Plus Aspiration Catheter
- K173503 — Pollogen Legend System
- K173787 — X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
- K173803 — Omnican fine
- K180649 — BeautiCem Veneer Kit
- K180722 — CAPERE Thrombectomy System
- K180766 — Endiscope, Endiscope Cervical
- K180849 — Vinyl Examination Glove (Clear, Non-Colored)
- K180959 — Phenom 27 Catheter
- K181281 — Altus Spine Pedicle Screw System
- K172725 — VT Dressing Kits
- K172981 — Reusable SpO2 Sensors, Disposable SpO2 Sensors
- K173070 — HSW Resection Instruments
- K173156 — Integrated CardioRespiratory System
- K173189 — Lumfuse TP
- K173706 — Piccolo Implants and Accessories
- K180306 — Nexy
- K180332 — 17HK700G-W
- K180449 — Single Use Aspiration Needle NA-U200H
- K180660 — Avanti
- K180904 — Sniper Infusion Catheter with Balloon Occlusion
- K180985 — Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
- K180988 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
- K172121 — Digital Thermometer
- K172721 — FOCAL ONE
- K172909 — ELEVARE, PERFECTIO 4
- K173032 — Paxman Scalp Cooler
- K173155 — Pakter Curved Needle Set
- K173573 — Tetric CAD
- K173577 — Guarded Luer Connector
- K180122 — TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
- K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
- K180459 — VERASENSE for Zimmer Biomet Persona
- K180612 — Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
- K180839 — AT 030
- K180947 — Orthopantomograph OP 3D
- K180956 — Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
- K181264 — QLAB Advanced Quantification Software
- K172221 — VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100
- K172780 — SD1 Ultrasonic Pocket Doppler
- K173053 — POWDER FREE LATEX EXAMINATION GLOVE
- K180427 — ARK Fentanyl Assay
- K180436 — T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
- K180621 — EchoMark, EchoMark LP
- K180672 — Sterilization Pouch/Roll Made with Tyvek
- K180709 — truSculpt RF Device; truSculpt; truSculpt 3D
- K180712 — Coconut Infused Hybrid Personal Lubricant
- K180832 — SALVATION External Fixation System
- K180925 — uMR 570
- K180926 — uMR 560
- K181202 — Sentry IVC Filter
- K181207 — Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
- DEN170089 — Curve Positive Airway Pressure System
- K172745 — ImmuGlo HEp-2 Elite IFA
Data sourced from openFDA. This site is unofficial and independent of the FDA.