FDA 510(k) clearances — page 744
clearances on record, most recent first.
Clearances — page 744
74,301–74,400 of 175,825- K022194 — TRAXX ELECTRIC WHEELCHAIR
- K022615 — CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
- K022626 — MOISTURESTAY (REVLON)
- K023303 — EXPORT ASPIRATION CATHETER
- K023323 — 1CC FUTURA SAFETY SYRINGE
- K023471 — DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
- K021210 — ARTERIA OCCLUSION BALLOON
- K021541 — NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
- K021635 — KARATS MULTIPURPOSE SOLUTION
- K022589 — ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
- K022612 — IBOND GLUMA INSIDE
- K022653 — ELITE MONOPHASE
- K022941 — MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
- K023042 — PQ1
- K023262 — POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)
- K023300 — HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J
- K023343 — ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
- K023368 — TRUCATH.IP
- K020339 — DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM
- K020934 — DR. JAPAN FACIL POINT SPINAL NEEDLE
- K021125 — SENSUA!
- K021186 — CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
- K021190 — PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
- K021306 — VECTORVISION CT-FREE KNEE
- K021564 — INCOMPASS SPINAL FIXATION SYSTEM
- K021630 — BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
- K021661 — RINGLOC CONSTRAINED LINERS
- K021728 — RINGLOC CONSTRAINED LINERS II
- K021742 — GALEMED NEB-EASY NEBULIZER
- K021854 — DFV CPG COLPOSCOPE
- K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
- K022243 — HORIZONS REUSABLE HOT BIOPSY FORCEPS
- K022268 — HORIZONS REUSABLE POLYPECTOMY SNARES
- K022356 — NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
- K022477 — SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
- K022484 — COOK INJECTION NEEDLE
- K022503 — UTERINE INJECTOR
- K022513 — MEDCOMP VASCU-SHEATH INTRODUCER SET
- K022604 — POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
- K022613 — HELIX HYDRO-JET
- K022706 — SPSMEDICAL SPORVIEW STEAM BI TEST PACK
- K022739 — REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002
- K022788 — PHILIPS HARMONY RELEASE 1
- K022938 — VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3
- K023002 — CLEARFIL AP-X PLT
- K023217 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K023220 — VARISOURCE BREAST TEMPLATE SYSTEM
- K023224 — INFUSION CATHETER EXTENSION SET
- K023302 — ECHELON POROUS PLUS HA HIP STEMS
- K023360 — LEFORTE SYSTEM BONE PLATE
- K023375 — MODIFICATION TO ESOP CO-CR FEMORAL HEADS
- K023399 — EBI XFIX DFS SYSTEM
- K023420 — PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
- K023428 — VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
- K020831 — PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
- K021250 — MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
- K021595 — GYRUS ENT NERVE STIMULATOR
- K021689 — PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
- K021690 — PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
- K021693 — PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
- K021923 — INRATIO SELF-TEST
- K022217 — AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
- K022540 — CARDIO ID+(RZ153+)
- K022741 — SPOT PRO (220V), MODEL 131.099
- K022999 — CLEARFIL AP-X PLT INTRO KIT
- K023058 — QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
- K023158 — RANDOX APOLIPOPROTEIN CALIBRATOR
- K023182 — INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
- K023190 — E.CAM COMPUTER / E.SOFT WORKSTATION
- K023194 — SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
- K023208 — CEDIA CYCLOSPORINE PLUS ASSAY
- K023223 — MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
- K023475 — CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
- K020285 — CMA CEREBRAL TISSUE MONITORING SYSTEM
- K023202 — MICROSCAN SYNERGIES PLUS
- K023332 — LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
- K021608 — SMITHWICK CAROTID SHUNT
- K022420 — MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
- K022450 — INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
- K022535 — MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
- K022582 — EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
- K022667 — HCMI X-RAY
- K022737 — HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
- K022881 — CEDARA I-SOFTVIEW
- K023055 — BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200
- K023227 — USG 2000SA
- K023287 — DRYSTAR 5500
- K020231 — DIASOL-ADDITIVES
- K021443 — 56 SERIES JET NEBULIZER
- K022391 — MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
- K022774 — IQ 200 SYSTEM
- K022907 — ANSPACH POWERED KERRISON SYSTEM (PKS)
- K022913 — NXSTAGE PREMIXED DIALYSATE
- K022942 — CRANIOCUT
- K022987 — LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K023245 — BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
- K021200 — COMPAS
- K021451 — DURACON CS TIBIAL INSERT
- K021688 — NICALERT
- K022043 — SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
Data sourced from openFDA. This site is unofficial and independent of the FDA.