FDA 510(k) clearances — page 767
clearances on record, most recent first.
Clearances — page 767
76,601–76,700 of 176,637- K021353 — POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
- K021445 — ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
- K021462 — ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
- K021463 — MODEL 1133 IVD PC VERSION
- K021494 — GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
- K021502 — OSCAR, MODEL OE3000
- K021506 — POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES
- K021518 — PAINDOC
- K021519 — ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
- K021704 — VAXCEL PICC WITH PASV VALVE TECHNOLOGY
- K013654 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
- K013902 — U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
- K020772 — OMEGA II SYSTEM
- K020779 — PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
- K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3
- K020969 — VACURECT VACUUM CONSTRICTION DEVICE
- K021260 — REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
- K021559 — ASCENT ALL-POLY PS TIBIAL BEARINGS
- K021584 — REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
- K021621 — FIXED BEARING UNI COMPONENT
- K021669 — PHYSICIAN'S DESKTOP REVIEW
- K010132 — KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
- K013032 — PHYSIOLOG, SERIES 95000
- K013213 — HYPERION VISIQUANT ANA TEST KIT
- K013321 — SILICONE TRACHEAL T-TUBES
- K020364 — PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
- K020368 — OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT)
- K020389 — BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
- K020395 — AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
- K020487 — CARESIDE ALT
- K020729 — NLITE SYSTEM,MODEL A00-1051
- K020741 — UNICONDYLAR KNEE
- K020855 — IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT
- K021295 — SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
- K021420 — PARACON II/FECAL CONCENTRATOR II
- K021700 — ANIMUS EZSERTER INFUSION SET INSERTER
- K012667 — REPROCESSED ARTHROSCOPIC SHAPERS
- K013733 — SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET
- K014040 — FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS
- K014247 — TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
- K020711 — WALLACH LOOP ELECTRODE
- K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
- K020736 — TRAATEK COTTONOID PATTIES
- K020739 — BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
- K020764 — NAVIPRO
- K020776 — MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
- K020821 — SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
- K020900 — DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
- K020938 — MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
- K021032 — ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
- K021129 — CHARE CARIOVASCULAR PATCH
- K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
- K021448 — MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
- K013258 — INPATH E2 COLLECTOR
- K013712 — ENTERYX INJECTOR
- K020033 — MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
- K020802 — RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
- K020945 — AXSYM INTACT PTH, MODEL 2G06
- K021000 — SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES
- K021379 — SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
- K021403 — HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
- K021531 — RPI REPLACEMENT PHOTOTHERAPY LIGHTS
- K021563 — INTRACOIL SELF-EXPANDING PERIPHERAL STENT
- K021606 — EN-SNARE ENDOVASCULAR SNARE AND CATHETER
- K021628 — SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
- K013021 — LIGHTLANCE LASER SKIN PERFORATOR
- K013646 — ROSE K POST GRAFT LENS
- K020673 — WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
- K020732 — SS MATRIX
- K020952 — SURX RF SYSTEM
- K021206 — IMMULITE 2000 SPECIFIC ALLERGENS
- K021208 — IMMULITE 2000 MIXED ALLERGEN PANELS
- K021364 — MODIFICATION TO ENTEC PLASMA WANDS
- K021374 — TOESCO AQUA BLUE LED LIGHT CURING DEVICE
- K021587 — ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
- K021589 — ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
- K021612 — DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
- K021614 — DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
- K013615 — MICRO-INDUCTION 1000 SYSTEM
- K020646 — REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162
- K021384 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
- K021411 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
- K021414 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
- K021415 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
- K021439 — MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
- K021577 — MODIFICATION TO EN-BLOC BIOPSY SYSTEM
- K011461 — ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
- K013687 — NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
- K020637 — SELECT STIM
- K020640 — KSEA SCB MEDIA CONTROL
- K020643 — EZ-SCOPE AN & EZ-SCOPE AN LITE
- K020699 — TSRH SPINAL SYSTEM
- K020743 — PADPRO, MODEL 2502
- K020778 — GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
- K020893 — NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
- K021118 — DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
- K021121 — AROMACRYL
- K021380 — OSS LES PROXIMAL FEMORAL COMPONENT
- K020315 — 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
- K020614 — IRRIGATING CANNULA
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