FDA 510(k) clearances — page 679
clearances on record, most recent first.
Clearances — page 679
67,801–67,900 of 175,825- K041442 — EP-4 CLINICAL STIMUTATOR
- K041522 — FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
- K041528 — MODIFICATION TO EPTFE GRAFT
- K041771 — TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM
- K041795 — MODIFICATION TO OPTICAL SEPARATOR SYSTEM
- K041964 — MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS
- K041982 — VITEK 2 GRAM NEGATIVE ERTAPENEM
- K042113 — ZOE FLUID STATUS MONITOR
- K042157 — DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K042328 — SOMATOM SPIRIT
- K042389 — MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
- K040143 — MONORAIL
- K041621 — LITEPORT LP100 SURGICAL ILLUMINATOR
- K041692 — INFRARED EAR THERMOMETER, ET-100 SERIES
- K041694 — DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
- K041784 — RAVEN PROTEST - EO
- K041941 — SAFE T RETRACTABLE BLOOD COLLECTION DEVICE
- K033341 — SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
- K040026 — BD FACS 7-COLOR SETUP BEADS
- K040178 — PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
- K040491 — CHIN-UP STRIP
- K040725 — BD FACSCANTO SYSTEM
- K041285 — GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
- K041381 — MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
- K041578 — QUICKSCREEN, MODELS 9177X AND 9178X
- K041791 — 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
- K041811 — ABBOTT AXSYM TROPONIN-I ADV
- K041867 — HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
- K041906 — EXACTECH 12/14 TOTAL HIP SYSTEM
- K041930 — VARILITE LASER SYSTEM
- K042026 — BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
- K042202 — TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502
- K042225 — ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
- K042262 — INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
- K042280 — FACT PLUS ONE-STEP PREGNANCY TEST KIT
- K042294 — SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
- K040079 — M.L. PRIMER
- K040901 — STERITEC EMU-GRAPH, MODEL NO. CI 131/US
- K041186 — CADDY
- K041215 — CRANIAL HELMET
- K041361 — RANDOX TRI LEVEL CARDIAC CONTROL
- K041468 — PREMICATH, 1261.205
- K041743 — ACON TRI-FECT DRUG SCREEN TEST DEVICE
- K041764 — THE VITROS 5,1 FS CHEMISTRY SYSTEM
- K041924 — HAUSTED POWERTRAN SERIES STRETCHER
- K042139 — VISULAS YAG III
- K042151 — ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
- K042213 — PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
- K042311 — PACSPARTNER
- K042313 — INTEGRADWEB MPR/MIP
- K021096 — X-SIZER CATHETER SYSTEM
- K034021 — VACUUM ASSISTED CORE BIOPSY DEVICE
- K040662 — VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS
- K041237 — ECHOSAMPLER
- K041346 — SYNERGY ULTIMATE
- K041516 — DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
- K041566 — SONOSURG ULTRASONIC SURGICAL SYSTEM
- K041611 — SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
- K041617 — STALIF TT
- K041625 — LTD POLYAXIAL FIXATION SYSTEM
- K041655 — BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
- K041660 — TRIMEDYNE HOLMIUM LASER SYSTEMS
- K041706 — HOFFMANN II FOOT RING
- K041709 — NUMELOCK II SYSTEM
- K041749 — SCANDIUS ACL RECONSTRUCTION SYSTEM
- K041786 — CALCAMEA PLATE
- K041801 — EXPEDIUM MIS SPINE SYSTEM
- K041860 — SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
- K041872 — ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS
- K041911 — SYNTHES (USA) LCP CURVED PLATES
- K041923 — BIOBLANKET
- K041936 — BIOPRO SUBTALAR IMPLANT
- K041965 — ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
- K042013 — DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
- K042128 — MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
- K042130 — AURA CPAP PATIENT INTERFACE
- K042136 — SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
- K042167 — MODIFICATION TO: CD HORIZON SPINAL SYSTEM
- K042199 — TRANSLUX POWER BLUE
- K042234 — MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
- K042257 — DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
- K042269 — LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
- K042292 — ISITE PACS
- K042293 — BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
- K042304 — CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251
- K042309 — BIOSOMNIA-V3
- K042325 — TROCHANTERIC NAIL SYSTEM
- K033164 — ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM
- K040965 — PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
- K041082 — NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
- K041754 — STRYKER MAESTRO SYSTEM
- K041829 — FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
- K041883 — SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
- K041904 — COMPASS F10 SYSTEM
- K042170 — EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120
- K042190 — MODEL 6416 TEMPORARY PACING LEAD SYSTEM
- K042260 — PHOT-X II, MODEL 303
- K033026 — MALLARD MODEL 3000 ANESTHESIA MACHINE
- K040493 — OUTOLOGOUS SPINAL FIXATION SYSTEM
- K041520 — MANTRA TENS MODEL NT3
Data sourced from openFDA. This site is unofficial and independent of the FDA.