FDA 510(k) clearances — page 369
clearances on record, most recent first.
Clearances — page 369
36,801–36,900 of 176,542- K142682 — The Lipogems System
- K142771 — Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K142787 — Zimmer Persona Personalized Knee System
- K142807 — ANTHEM PS Total Knee System
- K143067 — Carnation Ambulatory Monitor
- K143069 — HEMASORBPLUS press Resorable Hemostatic Bone Putty
- K143138 — AxSOS 3 Ti Locking Plate System
- K143195 — Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)
- K143429 — Passage Hemostasis Valve
- K142735 — The Optilite IgG3 kit
- K141161 — ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
- K132407 — VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
- K133800 — ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
- K140440 — NORIS MEDICAL DENTAL IMPLANTS SYSTEM
- K140554 — IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
- K140668 — PLATINUMGMT IPL SYSTEM CLOUD
- K140772 — AEROSURE MEDIC
- K141693 — Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
- K141752 — NXSTAGE SYSTEM ONE
- K141926 — INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- K141969 — FIRSTSTIC N INTRODUCER
- K142022 — MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
- K142041 — POROSTEON PHUSION METAL CERVICAL CAGE
- K142111 — ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE
- K142154 — PK NEEDLE
- K142194 — CytoSure Urinary Access System
- K142204 — Bioceptive Suction Cervical Retractor
- K142271 — Zavation Z-Link Lumbar
- K142356 — Connex Spot Monitor,901058 Vital Signs Monitor Core
- K142362 — Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
- K142415 — Hi-Torque JET Guide Wire Family
- K142430 — LIFEPAK 15 monitor/defibrillator
- K142474 — S12 Digital Color Doppler Ultrasound System
- K142483 — TurboSEAL Nasogastric Aspiration Tube
- K142508 — Powder Free Yellow Vinyl Patient Examination Gloves
- K142638 — ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
- K142688 — Echotip Procore HD Ultrasound Biopsy Needle
- K142700 — InsufflatOR Needle
- K142701 — SMD Sr90-1 Radionuclide Brachytherapy Source
- K142707 — AIS Odontoid Fracture Fixation System
- K142738 — artus HSV-1/2 QS-RGQ MDx Kit
- K142777 — Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
- K142901 — RhythmView Workstation
- K142910 — Legacy BX
- K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
- K142968 — Full Automatic (NIBP) Blood Pressure Monitor
- K142998 — CPX Control Breast Tissue Expander
- K143161 — Force FX-8(S), Force FX-8C(S), Force FX-8CA(S)
- K143224 — TrueBeam-TrueBeam STx-Edge
- K143248 — Reform Pedicle Screw System
- K143328 — 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip
- K143339 — Mini me
- K143342 — Elecsys T-Uptake Calset
- DEN130004 — MOERAE SURGICAL MARKING PEN
- DEN140009 — AMIGO REMOTE CATHETER SYSTEM
- K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
- K140207 — RAPID-I KIT
- K140228 — DISPOSABLE TRACHEAL TUBE
- K140855 — ARTHREX SUTURETAK SUTURE ANCHORS
- K140978 — OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
- K141214 — AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
- K141218 — ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM
- K141420 — FASTFORWARD
- K141474 — BECTON DICKINSON INTELLIPORT SYSTEM
- K141530 — VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
- K141712 — KIMGUARD ONE STEP STERILIZATION WRAP
- K141727 — DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES)
- K141764 — TRISTAR BONE GRAFT FIXATION SYSTEM
- K141893 — VIBRANCE KEGEL DEVICE (VKD)
- K142043 — INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA
- K142049 — MULTIX FUSION VA30 & VA40
- K142235 — CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
- K142239 — CPS Direct MediGuide Enabled outer catheter
- K142333 — SMART LABEL, PROPOFOL
- K142342 — NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K142378 — Interspinous Plate System
- K142457 — Quickie, Zippie
- K142463 — Bio2 CLM BG Bioactive Scaffold
- K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
- K142514 — UniWeb 8.0
- K142570 — Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
- K142588 — Nitrile Powder Free Examination Glove (Blue)
- K142609 — CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
- K142619 — Snap Insulin Pump System
- K142631 — Hermes Medical Imaging Suite v5.5
- K142686 — StimPad OTC
- K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
- K142737 — MAS PLIF Fixation system
- K142805 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
- K143009 — Echo Bi-Metric Microplasty Hip System
- K143050 — VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
- K143119 — LT-300 Video Colposcope
- K143186 — Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
- K143307 — RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
- K143403 — Threshold Pedicular Fixation System
- K131643 — DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT
- K140284 — GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
- K140536 — HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE
- K140592 — CERAGEM AUTOMATIC THERMAL MASSAGER
- K140793 — NANOSTIM INTRODUCER KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.