FDA 510(k) clearances — page 715
clearances on record, most recent first.
Clearances — page 715
71,401–71,500 of 175,825- K031697 — DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
- K031700 — MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
- K031710 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K031730 — 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
- K031975 — IMSURE
- K032213 — STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
- K032254 — IBL C1Q-CIC CIA TEST
- K032256 — QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE
- K032382 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
- K032390 — MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
- K032409 — VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
- K032526 — BINDER CO2 INCUBATOR SERIE CB
- K032579 — S2 NAIL SYSTEM
- K031712 — INION OTPS BIODEGRADABLE PIN
- K032293 — NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN
- K032294 — NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING
- K032325 — JOBST TRAVEL SOCKS
- K032432 — BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
- K032453 — ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
- K021161 — TSO3 OZONE CHEMICAL INDICATOR
- K023617 — DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
- K030381 — PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
- K030525 — CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
- K030586 — MICROPEAK
- K030693 — KENTEX DISPOSABLE VAGINAL SPECULUM
- K030898 — MOBILE BATTERY SERVICE STATION (MBSS)
- K031043 — D-10 HEMOGLOBIN A1C
- K031187 — HEARTSTART MRX, MODEL M3535A
- K031665 — IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
- K031748 — VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
- K031984 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
- K032026 — LCD MONITOR, RADIFORCE G11, G31, G51
- K032041 — DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
- K032069 — WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
- K032070 — ELCACAM
- K032276 — CLICK HOLTER
- K032360 — MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
- K032498 — DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
- K020875 — TSO3 OZONE STERILIZER, MODEL 125L
- K022721 — UROPOWER
- K030440 — OASYS-ORAL AIRWAY SYSTEM
- K031678 — HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K031740 — VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES
- K032236 — DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K032250 — GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
- K032272 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
- K032297 — DISPOSABLE N-PE MICKROKERATOME BLADES
- K032298 — MODIFICATION TO OUTBACK CATHETER
- K032376 — ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
- K023856 — VISUALINE METHADONE DIPSTRIPTEST
- K023913 — NEUROTECH BAXOLVE TYPE 294
- K024250 — MATCH PRESS PRESSABLE CERAMIC
- K030374 — SONIK LDI 20 AIR
- K030977 — DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
- K030980 — DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
- K031883 — LYRA NASAL MASK
- K031921 — LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS
- K032018 — EASY PULSE II OXYGEN CONSERVER
- K032078 — MITEK MICRO QUICKANCHOR
- K032106 — STARBOND DENTAL BONDING ALLOYS
- K032203 — HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
- K032341 — INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
- K032415 — MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
- K032474 — 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL
- K032500 — MODIFICARION TO WACKERS-LIU CQ SOFTWARE
- K012681 — ANKYLOS
- K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
- K023400 — FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
- K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
- K031155 — OSTEOMED SUBTALAR IMPLANT SYSTEM
- K031318 — TRAXIS CEMENT RESTRICTOR
- K031637 — INNOVA 3100
- K031639 — INTERMED ZOOM COLPOSCOPE
- K031657 — STRYKER SPINE OASYS BONE SCREW
- K031692 — SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
- K032005 — MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
- K032049 — ROCHE ONLINE TDM VALPROIC ACID
- K032068 — CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
- K032261 — Trellis Reserve Infusion System
- K032306 — VERSATREK
- K032314 — VITEK 2 GRAM POSITIVE GATIFLOXACIN
- K032448 — ALTATEC CERAMIC ABUTMENT
- K032464 — ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
- K032466 — SPIDERVIEW
- K032483 — VIATRONIX V3D EXPLORER, REVISION 1.2
- K032503 — EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
- K030367 — COLUMBUS (PS)
- K030574 — GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
- K031204 — DENTAPORT ZX
- K031677 — SYNTHES (USA) CALVICLE HOOK PLATE
- K031735 — CENTURION SES EPIKERATOME
- K031749 — BODYGUARD INFUSION SYSTEM
- K031771 — SHIMADZU COLLIMATOR R-30H
- K031885 — NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
- K031907 — NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551
- K031954 — COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
- K031994 — LINVATEC 300W XENON LIGHT SOURCE
- K032057 — TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
- K032090 — NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
- K032209 — NOMOS CORVUS 5.0M
Data sourced from openFDA. This site is unofficial and independent of the FDA.