FDA 510(k) clearances — page 632
clearances on record, most recent first.
Clearances — page 632
63,101–63,200 of 176,637- K060201 — OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
- K060299 — ART BRACHYTHERAPY APPLICATOR
- K060375 — BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166
- K060389 — CONFIDOSE IM AUTO-INJECTOR
- K060463 — HEMA SCREEN SPECIFIC IFOBT
- K060580 — K-SHIELD PORT ACCESS INFUSION SET
- K060632 — VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
- K060664 — FASTIN RC ANCHOR
- K060693 — MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
- K060844 — SILKLINE SOFT RELINING KIT, MODEL 28-100100
- K060963 — TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)
- K061019 — TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
- K061083 — CTS-7700
- K061114 — WDS, SIZE 2 AND SIZE 2
- K061244 — MUCOGRAFT
- K061312 — 36MM BIOLOX DELTA CERAMIC HEADS
- K061345 — MODIFICATION TO ENDIUS ATAVI SYSTEM
- K061384 — LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM
- K052469 — GLUCOPACK
- K060347 — B&L L-BETA, MODEL WL-B1
- K060862 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K060885 — MODEL MI 44 TYMPANOMETER
- K060937 — BRILLIANCE VOLUME
- K061006 — IKOENGELO
- K061035 — TIGERVIEW PROFESSIONAL
- K061235 — LIFESTENT TURBO BILIARY STENT SYSTEM
- K061308 — TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
- K061351 — ORAL-B SONIC COMPLETE
- K061426 — OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
- K051342 — MEDICAL INTERPOROUS
- K053305 — SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
- K060002 — RITRACT SAFETY SYRINGE
- K060053 — STOCKERT S5 SYSTEM
- K060138 — SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
- K060536 — OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
- K060563 — EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
- K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793
- K060670 — ACCIN UNI-KNEE SYSTEM
- K060721 — LARIAT LOOP APPLICATOR
- K060732 — MBCP GEL
- K060744 — O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
- K061031 — D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
- K061073 — CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250
- K061079 — MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
- K061171 — SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
- K061240 — SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES
- K061249 — AXSYM DIGOXIN III
- K061282 — ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
- K061314 — BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
- K061320 — R&D LH-NRBC HEMATOLOGY CONTROL
- K061322 — PORCELAIN PRIMER
- K061381 — LC STAR WITH NASAL ADAPTER
- K052254 — MYTIS ARROW XXXX
- K061129 — GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
- K061183 — CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
- K061189 — DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K051104 — EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
- K053629 — ANCHOR PLUS/NEO ANCHOR PLUS
- K060172 — REMA SHAVER BLADES
- K060200 — MICROTEK MEDICAL WARMING DRAPE
- K060352 — HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
- K060407 — JUNIPER COOLING DEVICE
- K060707 — AESCULAP BIPOLAR ACETABULAR CUP
- K060905 — IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1
- K061025 — ACCUTECH ENDOLITE PROBE
- K061095 — AUTO SUTUR ENDO GIA STAPLERS
- K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
- K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
- K061253 — REFLECTION 3 ACETABULAR SYSTEM
- K061343 — INSPIRSTAR GLOVE ELECTRODE
- K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
- K060189 — PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
- K060258 — AUTOFUSER
- K060374 — REFA, PHYSIOLOGICAL AMPLIFIER
- K060449 — HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
- K060539 — DPOAE20 , ECLIPSE
- K060561 — CLEARADEX GEL
- K060645 — PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
- K060692 — COMPREHENSIVE PRIMARY SHOULDER STEMS
- K060850 — NOD CHEMISTRY CONTROL
- K060922 — OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5
- K061196 — CARDIOIMMUNE XL CARDIAC MARKER CONTROL
- K061201 — DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
- K061370 — CARDIQ FUSION
- K061372 — CENTRICITY AW SUITE OPTION
- K061396 — QLAB QUANTIFICATION SOFTWARE
- K052271 — RINSENDO
- K053382 — LAPARO-THORACO VIDEOSCOPE XLTF-VAW
- K060546 — BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
- K060722 — NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT
- K060735 — DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
- K060918 — EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
- K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
- K061228 — FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
- K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
- K053359 — RAPIDTOX
- K053452 — PURE-AID PREGNANCY TEST
- K060128 — CLEARBLUE EASY DIGITAL PREGNANCY TEST
- K060157 — IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
- K060227 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
Data sourced from openFDA. This site is unofficial and independent of the FDA.