FDA 510(k) clearances — page 678
clearances on record, most recent first.
Clearances — page 678
67,701–67,800 of 175,825- K042342 — MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL
- K042412 — MODIFIED SPACEMAKER SYSTEM
- K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
- K041127 — MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
- K041279 — IMPLANTEO IMPLANTOLOGY MOTOR
- K041591 — SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
- K041722 — MODIFICATION TO VBR SPINAL SYSTEM
- K041909 — VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
- K042016 — DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
- K042105 — CLIPPER DIAGNOSTIC ELECTRODE CATHETER
- K042276 — D-VAPOR
- K042374 — STOCKERT SCP RHYTHM
- K042456 — Lysus Infusion System
- K032922 — CLARISSA INFANT NCPAP CANNULA
- K040213 — MHLX7EC TRANSDUCER
- K040915 — MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
- K041330 — IPLAN! FLOW
- K041734 — AMBU DISPOSABLE ECG ELECTRODE
- K041890 — CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
- K041902 — MANTRA ELECTRODE
- K042122 — SMARTINFUSER PAINPUMP
- K042426 — TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
- K042463 — HOLTER PLUS
- K040070 — ARTELON SPACER CMC-1
- K041732 — CAVERMAP SURGICAL AID
- K041779 — NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
- K041805 — MICROSCOPE SYSTEM
- K042042 — ULTRASOUND CAPTURE SYSTEM
- K042215 — RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
- K042354 — MODIFICATION TO: CRESCO TI IMPLANT CONCEPT
- K042462 — AMERICAN DENTAL IMPLANT
- K032878 — KUNG SHIN, HMEF SK203
- K040209 — IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
- K041268 — SILVERSITE OR CALGITROL
- K041491 — ZEWA MFM-007 BLOOD PRESSURE MONITOR
- K041524 — GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
- K041593 — FEATHERLIFT EXTENDED LENGTH APTOS THREAD
- K041863 — VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
- K042100 — BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
- K042142 — CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
- K042205 — BONE FUSION PLATE SYSTEM
- K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM
- K042296 — BIOMARC PRELOADED TISSUE MARKER DEVICE
- K042341 — ULTRACLIP II US
- K042346 — LNCS OXIMETRY SENSORS
- K042378 — NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
- K033543 — NARCOTREND, MODEL COMPACT 4.0
- K040533 — EZ HUBER SAFETY INFUSION SET
- K041074 — BD FACSCANTO WITH BD FACSANTO SOFTWARE
- K041894 — ORTHOFIBER
- K042041 — XPLORER 1600
- K042085 — CRONO F
- K042145 — READY-HEAT BLANKET
- K042146 — ROBOCOUCH PATIENT SUPPORT SYSTEM
- K042235 — ORION ANTERIOR CERVICAL PLATING SYSTEM
- K042251 — BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
- K042335 — ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
- K042428 — SCEPTREP3 PET/CT
- K033570 — MEDCOMP T-3
- K033599 — ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
- K040377 — RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
- K040591 — DUET SYSTEM
- K040904 — PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
- K041021 — RF INTRODUCTION CANNULA
- K041437 — MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE
- K041535 — LSC LIFESTAND COMPACT
- K041592 — CORAL SPINAL SYSTEM
- K041663 — ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
- K041751 — COMPRESSION ANASTOMOSIS CLIP (CAC)
- K041822 — ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
- K041989 — SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
- K041991 — ASPIREX - BONE MARROW ASPIRATE KIT
- K042030 — HYPROCURE SUBTALAR IMPLANT SYSTEM
- K042072 — CALLOS CMF BONE VOID FILLER
- K042195 — SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
- K042223 — XLTEK CONNEX IP HEADBOX, MODEL 1054
- K042237 — EBI PERIARTICULAR PLATING SYSTEM
- K042238 — CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
- K042244 — BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
- K042281 — MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
- K042295 — SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
- K042310 — ORTHO-PRO CANNULATED BONE SCREWS
- K042326 — ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER
- K042338 — CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
- K042429 — THE PRODIGY SYSTEM DENTAL IMPLANTS
- K033634 — EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
- K040942 — VST3
- K041206 — EPITOME SYSTEM
- K041862 — CD HORIZON SPINAL SYSTEM
- K041954 — DISPOSABLE MONITORING ELECTRODES
- K042020 — SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)
- K042194 — ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
- K042214 — POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
- K042242 — ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
- K042249 — CLS SPOTORNO STEM
- K042289 — MDI ORTHO
- K032991 — LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
- K040392 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
- K040479 — PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
- K041269 — ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.