FDA 510(k) clearances — page 793
clearances on record, most recent first.
Clearances — page 793
79,201–79,300 of 175,825- K011277 — HARD RELINER
- K011321 — MODIFICATION TO XPS 3000 SYSTEM
- K011410 — PARA 5X
- K011542 — SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D)
- K011554 — LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
- K011579 — LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
- K011670 — DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
- K003068 — SAVINA
- K003894 — ORACLE ORAL MASK
- K010239 — COCAINE DIPSTICK TEST, MODEL D747-A
- K010325 — WAKO AUTOKIT C4
- K010326 — WAKO AUTOKIT C3
- K010334 — WAKO LIPID CALIBRATOR
- K010703 — INTER-VIAL
- K010921 — ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
- K010937 — SEP-10S PLUS, AND SP-12S PRO.
- K010957 — QUELL DESENSITIZER
- K011119 — BRACHYSEED PD-103 MODELS #PD1
- K011145 — MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
- K011181 — ICS MEDICAL CHARTR OAE WITH TYMP
- K011222 — PORTABELL, MODEL 4200
- K011226 — CALIBRATOR FOR AUTOMATED SYSTEMS
- K011245 — ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM
- K011348 — PHASE II GBM IGG ANTIBODY EIA TEST
- K011383 — MICRODOSE CATH, MODELS 90121-201, -202, -203
- K011424 — IL TEST PROS
- K011720 — OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
- K002427 — SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
- K003877 — MAR COR SERVICES SEMPER PURE RO MACHINE
- K010184 — CHESS HAND SURGERY SYSTEM
- K010233 — POWDER FREE NITRILE EXAMINATION GLOVES
- K010872 — ML BLADE, MODEL ML7030
- K010920 — TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
- K010941 — THE NIMBLE ROCKET POWERED WHEELCHAIR
- K010990 — AMS SLING FIXATION SYSTEM
- K011015 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K011018 — TAUT BALLOON CATHETER, MODEL 50640
- K011168 — NEUROGEN NERVE GUIDE
- K011270 — AUTOMATED CORE BIOPSY DEVICE
- K011309 — LUTE VLC; CORE VLC
- K011330 — JP CAST 50
- K011331 — JP CAST 40
- K011435 — HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
- K011584 — MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
- K011612 — MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
- K011675 — THE AUTOTAC SYSTEM
- K011677 — MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
- K011701 — BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
- K011755 — STRYKER T4 HYTREL (R) TOGAS
- K011773 — DORNIER LITHOTRIPTER 140(DOLI 140)
- K011789 — PROCEDURE MASKS: PM4-301 AND PM4-304
- K002885 — DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
- K010026 — EMBOGOLD MICROSPHERE
- K010838 — FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008
- K010874 — 6F MACH 1, MODEL 34356-XXX
- K011389 — HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
- K011576 — MEDCOMP ASH SPLIT
- K011593 — MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE
- K011616 — INDUO BLOOD GLUCOSE METER
- K010406 — JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
- K010410 — JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
- K010456 — BIOSCANNER CREATININE TEST STRIPS
- K010876 — NTI TENSION SUPPRESSION SYSTEM
- K010884 — TITANIUM COMPRESSION ANCHOR SYSTEM
- K010916 — PTW DOSIMETRY DIODE, T60008
- K010940 — SEALAPEX 4
- K011150 — DRIDAU OPIATE ASSAY
- K011284 — THIN FILM DRESSING FOR ULTRASOUND EXAM
- K011292 — ZIEHM VISION
- K011297 — NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
- K011486 — Q-RAD RADIOGRAPHIC SYSTEM
- K011656 — HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
- K011738 — ACCU-CHEK ACTIVE SYSTEM
- K003026 — PFC SIGMA LUGGED TIBIAL TRAY
- K010847 — K'FIX
- K010897 — MERIDIAN-PORTABLE
- K010901 — FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
- K010902 — MEDPOR QUAD MOTILITY IMPLANT
- K010927 — MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
- K010928 — PROLITE VL PULSED LIGHT SYSTEM
- K010987 — KSEA MINIATURE TELESCOPE AND ACCESSORIES
- K010988 — FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
- K011137 — RESORBABLE HAMMERTOE PIN
- K011172 — ARTHREX BIO-TRANSFIX
- K011187 — SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
- K011567 — TORNIER TOTAL ELBOW PROSTHESIS
- K011577 — OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S
- K011634 — ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000
- K011819 — RADIAL HEAD IMPLANT
- K011858 — INTERLINK THREADED LOCK CANNULA
- K010553 — PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
- K010870 — LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
- K010974 — RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
- K011211 — FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
- K011396 — IBD-CHEK
- K011548 — CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3
- K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
- K003433 — NEURO-TRAIN III (3)
- K003905 — ACTI-ICP MONITORING SYSTEM
- K003920 — CORDIS M3 PTA DILATATION CATHETER
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