FDA 510(k) clearances — page 799
clearances on record, most recent first.
Clearances — page 799
79,801–79,900 of 175,825- K011012 — POWDER FREE NITRILE EXAMINATION GLOVE
- K011093 — AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
- K011096 — ABBOTT ACCLAIM ENCORE, MODEL 12237
- K003023 — COBE HC 700 MIDI HEMOCONCENTRATOR
- K003812 — VACUETTE SPEEDY QUICK-RELEASE HOLDER
- K004038 — TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
- K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
- K010708 — APPLICATOR TIP/DUAL SPRAYER KIT
- K010835 — POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
- K010886 — SIMPLICITY WING INFUSION SET
- K010993 — ALIEN RX MICRO CANNULA, MODEL 4530
- K000889 — SENOJ IMPLANT SYSTEM
- K001915 — GRAFT MARKER RING
- K003325 — KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
- K003740 — MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
- K010178 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM
- K010260 — HANSATOME MICROKERATOME
- K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
- K010268 — FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
- K010275 — DRYSTAR 4500 PRINTER, MODEL 4500
- K010353 — MED-LOGICS DISPOSABLE ALK TUBING
- K010371 — LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
- K010509 — CEDARS-SINAI BPGS AND MOCO
- K010529 — TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
- K010662 — MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
- K010665 — TRANSAMERICA DIGITAL EMS
- K010722 — PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
- K010782 — TRANSAMERICAN TENS
- K010789 — CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
- K010823 — SPAZZ
- K011016 — LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
- K992607 — SONICAID SYSTEM 8002
- K002627 — ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
- K002973 — EMBOL-X INTRODUCER, MODEL CF00200
- K003077 — SMARTSCREW MODEL 222006...227510
- K003559 — TCI (TINNITUS CONTROL INSTRUMENT)
- K003987 — URS-1K (KETONE TESST)
- K004010 — ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
- K004046 — COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- K010252 — MAGNUM
- K010259 — MEDIFACE PACS
- K010283 — THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
- K010417 — CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
- K010440 — FREELITE LAMBDA FREE KIT
- K010441 — FREELITE KAPPA FREE KIT
- K010670 — PICCOLO CHLORIDE TEST SYSTEM
- K010726 — MODIFICATION TO MIRAGE
- K010955 — BMT ANSCORE HEALTH MANAGEMENT SYSTEM
- K010960 — EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
- K010962 — EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
- K011086 — HARDYDISK BACITRACIN, 10MCG, MODEL Z927
- K003206 — GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
- K010245 — ACTIVHEAL SCAR MANAGEMENT DRESSING
- K010273 — CRANIAL MOLDING ORTHOSIS
- K010451 — NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
- K010527 — SYNTHES (USA) IMF SCREWS
- K010578 — TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
- K010889 — BABY DOPPLEX 3000 MK 2 (BD3000)
- K010894 — BABY DOPPLEX 3002 (BD3002)
- K000442 — ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
- K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
- K010225 — DOSIMETRY CHECK
- K010536 — MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K010537 — LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K010550 — VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
- K010625 — EUROSPITAL EU-TTG IGA UMANA
- K010627 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K011081 — ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
- K011116 — PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
- K003275 — SYNTHES SYNMESH SPACER SYSTEM
- K003381 — SHIELDING NEEDLE HOLDER
- K010508 — PASCO MIC AND MIC/ID PANELS
- K010626 — POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K010628 — POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
- K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
- K010994 — TAKE ONE BITE MODIFIED
- K003145 — ORIGEN BLADDER HOLDER
- K003440 — SOFTLASE - SURGICAL DIODE LASER SYSTEM
- K003809 — RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
- K010213 — MODIFICATION TO CAVERMAP SURGICAL AID
- K010255 — CAVITY VARNISH
- K010313 — DIMENSION CTNI FLEX REAGENT CARTRIDGE
- K010314 — DIMENSION CTNI CALIBRATOR
- K010341 — MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
- K010637 — SONOTOME ULTRASONIC ASPIRATOR TIPS
- K010788 — SIMPLICITY SOFT QD EASY INFUSION SET
- K010840 — SYNPLUG
- K010880 — NUMED HIGH PRESSURE PTA CATHETERS
- K010914 — BEAUTIFIL
- K010934 — EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
- K010969 — NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
- K010984 — EMIT 2000 GENTAMICIN PLUS ASSAY
- K011003 — SAFESTING AND SAFESTING HUB
- K011053 — OPTIMA
- K003521 — DISPO-MED 7.6 LITER SHARPS CONTAINER
- K010890 — BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)
- K010170 — TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
- K010172 — LEAD BLOCKS
- K010174 — TRAY ADAPTERS, MULTIPLE
- K010309 — SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
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