FDA 510(k) clearances — page 808
clearances on record, most recent first.
Clearances — page 808
80,701–80,800 of 176,637- 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
- K010383 — TEMP SCAN
- K010531 — ILT DEFLECTING CATHETER, MODEL C114ND1
- K010676 — SIMPLICITY WINGED QD INFUSION SET
- K010704 — DORNIR LC-1 CPAP SYSTEM
- K010810 — DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
- K010822 — AB CARDIETTE START 200 HV
- K010839 — CLS VARUS STEM/CLS 135 STEM
- K010845 — MODIFICATION TO OSTEONICS SPINAL SYSTEM
- K010853 — GUIDER SOFTIP GUIDING CATHETER XF 5F
- K010878 — MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
- K002036 — OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
- K002929 — DORNIER COMPACT ALPHA LITHOTRIPTER
- K003561 — INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
- K010149 — WUJIN #3 FEMORAL NAIL
- K010195 — PREMIER ULTRASONIC SCALER AND INSERTS
- K010630 — Y-TZP POWDER AND PROCERA ALLZIRKON
- K010740 — FG-36UX, FIBER ULTRASOUND GASTROSCOPE
- K010967 — LIVESURE COCAINE SCREEN TEST
- K010115 — REFLEX ANTERIOR CERVICAL PLATE SYSTEM
- K002131 — LACTOSORB ETHMOID STENT
- K003412 — ADVIA CENTAUR RUBELLA IGG ASSAY
- K003842 — PRESCOTT'S SURGICAL SPEAR
- K003994 — KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
- K010288 — ANEUVYSION MULITICOLOR DNA PROBE KIT
- K010379 — IL TEST FREE PROTEIN S
- K010421 — WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
- K010647 — SIMPLICITY INFUSER INFUSION SET
- K010765 — COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
- K010774 — AVL HINGE KNEE SYSTEM
- K010778 — NIAGARA SLIM-CATH
- K010781 — 3M ESPE HAUR
- K010812 — EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
- K010814 — EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
- K010956 — COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X
- K010959 — VERDICT -II BAR; VERDICT -II BZO
- K011011 — LIVESURE MORPHINE SCREEN TEST
- K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
- K010113 — LASER MECHANISMS LASER SCANNING SYSTEM
- K010507 — VISTAKON (METHAFILCON A) CONTACT LENSES
- K010684 — RX HERCULINK PLUS BILIARY STENT SYSTEM
- K010742 — MOSS MIAMI 5.5MM TITANIUM PIN NUT
- K010756 — CH 2000 CARDIAC DIAGNOSTIC SYSTEM
- K010758 — HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
- K010846 — SIMPLICITY SILVER SET SOFT INFUSION
- K010926 — R-SI-LINE METAL-BITE
- K010942 — U04
- K002997 — FIESTA IMAGING OPTION
- K003126 — BIPOLAR TRIGGER-FLEX PROBE
- K003326 — FUNET AMY MAMA BODY THERMOMETER
- K003463 — SOCON SPINAL SYSTEM
- K010104 — CANDELA LONG PULSE ND:YAG
- K010114 — ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)
- K010296 — UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
- K010462 — AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
- K010693 — VIGIL DNASE B CONTROL
- K010720 — TSRH SPINAL SYSTEM
- K010757 — LFIT V40 FEMORAL HEAD COMPONENTS
- K010786 — ULNAR HEAD IMPLANT
- K010795 — CAPNOPROBE SL, MODEL 2000
- K010821 — ECHOSEED/IODINE-125 SEEDS, MODEL 6733
- K010833 — AT WORK DRUG TEST, MODEL 9177T AWT
- K010836 — AT WORK DRUG TEST, MODEL 9147T AWT
- K002000 — MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS
- K003731 — SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
- K010486 — POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
- K010489 — DYONICS VISION 111 MOBILE VIDEO UNIT
- K010719 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
- K010767 — LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
- K010779 — MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
- K010784 — PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
- K001352 — REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
- K002902 — TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
- K002981 — ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
- K003494 — MIMIX BONE REPLACEMENT SYSTEM
- K003527 — MODIFICATION TO SYNTHES (USA) POLYPIN
- K003676 — RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR
- K003830 — ENT ENDOSCOPES
- K010086 — REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
- K010164 — ICG MODULE
- K010220 — XTRACTOR, MODEL M143
- K010265 — BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
- K010324 — STA-QUALITY HBPM/LMWH KIT
- K010328 — MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
- K010350 — STA -CALIBRATOR HBPM/LMWH KIT
- K010363 — ETEST MEROPENEM
- K010488 — ATAC PAK AST REAGENT KIT
- K010569 — KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP
- K010570 — BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
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