FDA 510(k) clearances — page 538
clearances on record, most recent first.
Clearances — page 538
53,701–53,800 of 176,542- K082879 — EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K082880 — EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
- K082883 — EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
- K083016 — ACTHYDERM
- K083144 — ACUMED CLAVICLE SCREW SYSTEM
- K090721 — CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
- K091161 — REJUVENATE MONOLITHIC SIZE 4 HIP STEM
- K091581 — SUPRA 577.Y LASER
- K081259 — DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K090289 — CLAVICLE PLATING SYSTEM
- K090468 — HAMILTON-C2
- K090706 — ONCENTRA SIMULATION 2.3
- K091103 — GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
- K091484 — NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
- K091545 — DIGITAL RADIOGRAPHY CXDI-60C
- K082367 — INFANT SLEEP BEANIE
- K082505 — KLS MARTIN ELECTROSURGICAL INSTRUMENTS
- K083352 — VEINWAVE, TC3000
- K083449 — E-MATRIX GRAFT BONE EXTENDER
- K083616 — PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS
- K090426 — VAKU-8 BLOOD COLLECTION NEEDLES
- K090511 — QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
- K090660 — AIRWAY BALLOON CATHETER INFLATION DEVICE
- K090929 — STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE
- K090961 — TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
- K090970 — FLOCONTROL , MODEL 1028
- K090998 — DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
- K091020 — BLUEPHASE 20I
- K091181 — LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS
- K091345 — GOPHER GOLD CATHETER, MODEL 5620
- K091432 — XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01
- K091527 — ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
- K091660 — CUSTOM COMFORT NIGHTGUARD VERSION 2
- K083687 — BAIXIN INTRAVASCULAR ADMINISTRATION SET
- K090012 — DISPOSABLE INFUSION SET
- K090671 — PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
- K090767 — PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
- K091400 — MODIFICATION TO AVIE A1C TEST SYSTEM
- K091490 — FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
- K083008 — COOLSKIN
- K083010 — SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR
- K083292 — HABIB ENDOHPB
- K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
- K090399 — TRIOS SYSTEM
- K090648 — VIPER 2 SYSTEM
- K090680 — HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
- K090747 — MI FLOW (GCUC-450)
- K090821 — CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L
- K091266 — THEKEN CORAL SPINAL SYSTEM
- K091505 — COR12+
- K091589 — MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
- K083275 — PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
- K090132 — MAXMORESPINE SPINAL SYSTEM
- K090161 — EPIPHANY INJECTION SYSTEM
- K091340 — THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
- K083669 — OBI
- K083716 — FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
- K090298 — NUVASIVE NEURO VISION SYSTEM
- K090546 — MODIFICATION TO NORDICICE SOFTWARE
- K090698 — CAPIOX BUBBLE TRAP WITH X-COATING
- K090926 — SMITH & NEPHEW RAIL SYSTEM
- K091260 — SERAQUEST EBV EA-D IGG TEST
- K080108 — CORTOSS BONE AUGMENTATION MATERIAL
- K083158 — EXALIS, SOFTWARE VERSION 1.15
- K083195 — MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN
- K083415 — PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
- K083723 — A6 LUER ACCESS DEVICE
- K083862 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
- K090172 — STAR 55 MODEL 100
- K090273 — KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
- K090283 — CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
- K090284 — RES-Q INFANT WEDGE AND SLING
- K090397 — XPI ANGLED ABUTMENTS
- K090443 — PLANET 55, MODEL 100
- K090455 — PROVOX VEGA, MODEL 8130-8135
- K090922 — EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
- K090933 — BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
- K090951 — RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG
- K090971 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
- K091315 — COVIDIEN EXTENDED TIP APPLICATOR
- K091370 — RADIA STEERABLE DIAGNOSTIC CATHETER
- K091395 — MP5 INTELLIVUE PATIENT MONITOR
- K091498 — VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
- K081410 — OPTION VENA CAVA FILTER
- K083772 — COLUMBUS REVISION KNEE SYSTEM
- K090114 — MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
- K090611 — REVOLUTION FULL CORE BIOPSY
- K090629 — EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
- K090675 — SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
- K090768 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909,
- K090769 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961
- K090770 — FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905
- K090771 — FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962
- K090772 — FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909
- K090909 — C-QUR V -PATCH MESH
- K090938 — FLOW CONTROLLER
- K090968 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
- K091019 — SPEEDCEM
- K091253 — THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
- K091323 — MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
Data sourced from openFDA. This site is unofficial and independent of the FDA.