FDA 510(k) clearances — page 362
clearances on record, most recent first.
Clearances — page 362
36,101–36,200 of 175,770- 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
- K140848 — LUMINESSE PORCELAIN SYSTEM
- K141163 — STERIZONE STERILIZER
- K141366 — VIDEO BRONCHOSCOPE SYSTEM
- K141580 — STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
- K141691 — GEN_3
- K141698 — STERIZONE CHEMICAL INDICATOR
- K142051 — PRELUDE PLASTIC JACKETED GUIDE WIRE
- K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM
- K142164 — MANIPULATOR; MANIPULATOR PRO
- K142377 — The OnControl Bone Marrow Biopsy System by Vidacare
- K142492 — GM60A-32S, GM60A-40S
- K142571 — Powder Free Vinyl Patient Examination Gloves
- K142718 — Radlink GPS
- K142721 — cobas MRSA/SA Test
- K142891 — HEPATIQ
- K142997 — RTHawk, HeartVista Workstation with RTHawk
- K143488 — InFill Graft Delivery System
- K140860 — ImmersiveTouch3 and MicrovisTouch
- K141009 — FORT DEFIANCE AUTOMATED STEAM STERILIZER
- K141295 — MERIT HYDROPHILIC GUIDEWIRE
- K141775 — SOFIA (R) STREP A+ FIA
- K142108 — RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
- K142419 — Mini and Micro Fragments Reconstruction System-NEOFIX
- K142639 — StitchKit
- K142715 — Sensor Medical Family of Vitrectomy Lenses and Products
- K142772 — Phlebo Press DVT 603
- K142789 — A1c iGear System
- K142919 — EXA
- K142944 — ArthroPlan Digital Templating Software
- K143052 — Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens
- K143284 — Elecsys Estradiol III Calcheck
- K143296 — AIA-PACK C-Peptide Control Set
- DEN140010 — PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
- K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
- K140667 — WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
- K140734 — NEXTGEN ALTIUS OCT SYSTEM
- K141330 — ENDO-CORD
- K141513 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
- K141575 — PLAC TEST FOR LP-PLA2 ACTIVITY
- K142329 — BBS REVOLUTION
- K142477 — Intact Advance and Intact Excision XL, Intact BLES
- K142490 — ProxiFuse Hammer Toe Device
- K142643 — Stabilynx PEEK Suture Anchor
- K143244 — The Panthera Anti-Snoring Device
- K143330 — BruxZir Anterior
- K133795 — SUMMED INFLATION DEVICE KIT
- K140091 — XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
- K140202 — TRAUSIM DENTAL IMPLANT SYSTEM
- K140350 — VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
- K140663 — THERASNORE
- K140680 — LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
- K140797 — IPACS MEDICAL IMAGE MANAGEMENT SYSTEM
- K141303 — ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
- K141304 — YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
- K141756 — INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
- K142081 — CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
- K142132 — POOL NORM
- K142180 — TELESENSE
- K142384 — DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
- K142620 — 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
- K142975 — Bovie Ultimate High Frequency Electrosurgical Generator
- K140669 — G7 OSSEOTI ACETUBLAR SHELLS
- K141053 — OVINE TISSUE MATRIX(OTM)
- K141389 — SAPPHIRE INFUSION PUMP
- K142146 — IBIS PEDICLE SCREW SYSTEM
- K142404 — iTotal Posterior Stabilized (PS) Knee Replacement System
- K142560 — Varian Head Frame
- K142607 — AngioVac Circuit
- K142661 — Bi-Portal Bone Graft Delivery Device
- K142800 — Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
- K133218 — Crystal ®; Mosaic ®; Vertu ®
- K140624 — HICURA HAND INSTRUMENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.