FDA 510(k) clearances — page 699
clearances on record, most recent first.
Clearances — page 699
69,801–69,900 of 175,825- K040248 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K031745 — INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
- K031931 — ECHO SOUNDER EX-101EX 8 MHZ
- K032619 — MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
- K032813 — THE ULTRA SYSTEM SP
- K033270 — NOVOSCI READY SYSTEM, MODEL RS-200
- K033615 — WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES
- K033715 — PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
- K033721 — VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
- K033769 — EIUS UNICOMPARTMENTAL KNEE SYSTEM
- K033791 — BAYER SPECIFIC PROTEIN REFERENCE SERUM
- K033838 — TITANIUM TOGGLE BUTTON(S)
- K033873 — ELECSYS C-PEPTIDE CALSET
- K033883 — OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI
- K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA
- K034036 — MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
- K040014 — PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
- K040062 — LEVIA PHOTOTHERAPY SYSTEM
- K040078 — CANNON II PLUS
- K040097 — MEDLINE STRIDER MIDI 3
- K040138 — VICEROY INFLATION DEVICE
- K040243 — BARD ATLAS PTA BALLOON DILATATION CATHETER
- K032371 — TITANIUM MESH SYSTEM
- K032446 — MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
- K032815 — PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
- K032844 — LIAISON 25 OH VITAMIN D
- K033011 — ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
- K033340 — LEKSELL SURGIPLAN WITH IMAGEMERGE
- K033426 — LIAISON N-TACT PTH
- K033718 — MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
- K040066 — SIREMOBILE C06
- K040072 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K040118 — VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC
- K040140 — IQ GUIDE WIRE
- K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
- K032305 — OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
- K032338 — TRIO MONITOR MODEL 0998-00-0600
- K032677 — SYSMEX POCH-100I
- K033573 — LINVATEC 10K IRRIGATION SYSTEM
- K040034 — BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
- K032067 — MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
- K032462 — CURAD SILVER ACTIVE GEL BANDAGE
- K032463 — CURAD SILVER BANDAGE
- K032706 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
- K033601 — LABONE MICRO-PLATE COTININE EIA
- K033622 — POLARCATH PERIPHERAL DILATATION SYSTEM
- K033800 — CAPIOX CARDIOTOMY RESERVOIR
- K033840 — CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
- K033941 — MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
- K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
- K032125 — CSTAT, MODELS 09-0014-01 AND 09-0014-02
- K033575 — ONE.CLICK NEEDLE
- K033674 — MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
- K033713 — URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
- K034030 — APOGEE ELITE
- K030685 — TEETH IN AN HOUR - ARK IMPLANT CONCEPT
- K031434 — BAWMED E-Z BAG RESUSCITATOR
- K032562 — PROCEARA COPINGS AND PONTIC
- K033213 — CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS
- K033703 — IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
- K033756 — VOLAR RADIUS PLATE WITH ANGULAR STABILITY
- K033822 — RESPIRONICS CUSTOM I ORAL APPLIANCE
- K033823 — RESPIRONICS CUSTOM II ORAL APPLIANCE
- K033974 — HERMES BOND
- K033999 — SEDLINE WITH FRONTAL PSI
- K034060 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)
- K040142 — ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
- K030837 — 40 L HIGH FLOW INSUFFLATOR F108
- K030877 — TRIMED RADIAL BULLET
- K031363 — QCA (VERSION 3.1)
- K031492 — MOSSMED DUAL INTERMITTENT ASPIRATOR
- K032416 — VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
- K032631 — INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)
- K033089 — HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
- K033272 — DEPUY SIGMA TIBIAL INSERTS
- K033382 — SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
- K033451 — HEARTRAK SMART AT/HEARTRAK SMART2
- K033527 — INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
- K033563 — SMARTSET GHV GENTAMICIN BONE CEMENT
- K033618 — SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
- K033751 — AEGIS PIT & FISSURE SEALANT WITH ACP
- K033777 — ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
- K033844 — SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
- K040101 — MODIFICATION TO DIADEXUS PLAC TEST
- K022650 — APEX MEDICAL CPAP RT 21XX
- K030293 — AMSURE RED RUBBER URETHRAL CATHETER
- K032216 — BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
- K032436 — DURAMAX .018 BILIARY STENT SYSTEM
- K032857 — PRESS-MATE BX-10 VITAL SIGN MONITOR
- K032969 — HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE
- K033470 — SIMULIX EVOLUTION
- K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE
- K033497 — BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
- K033652 — MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT
- K033706 — POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
- K033719 — BARD TIGERTAIL URETERAL CATHETER
- K033761 — GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
- K033813 — MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
- K033942 — THERMAGE THERMACOOL SYSTEM
- K033952 — PERIFIX CATHETER CONNECTOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.