FDA 510(k) clearances — page 545
clearances on record, most recent first.
Clearances — page 545
54,401–54,500 of 176,542- K083891 — VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
- K090080 — CIRRUS OPEN
- K090083 — CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
- K090286 — PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
- K090466 — DIGITAL RETINAL CAMERA, CR-1 MARK II
- K090634 — PHASEAL PROTECTOR P14, P21, P28 AND P50
- K090664 — DEVON ACCUBP CUFF
- K081269 — AVIE A1C TEST SYSTEM
- K082039 — SYNCHRO HP PLATFORM
- K082147 — BODYMETRIX BX2000
- K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
- K082819 — DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
- K083341 — NUVASIVE HELIX-T ACP SYSTEM
- K083425 — FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
- K083493 — MYOSCIENCE CRYO-TOUCH
- K083720 — OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
- K083802 — SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
- K083816 — RES TRAXX ONLINE, MODEL: R14
- K083830 — OSCAR BONE RESECTOR
- K083843 — LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
- K090136 — STERIS CMAX XLT SURGICAL TABLE
- K090408 — MODIFICATION TO: DSS STABILIZATION SYSTEM
- K090454 — ALLURE MB CERAMIC BRACKETS
- K090483 — SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
- K090509 — FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER
- K090521 — DIAMONDBACK 360 DBX
- K081424 — AFFIRM CO2 AND AFFIRM CO2 HP
- K081835 — ACTICARE IC AND TSE
- K082594 — REMESENSE
- K083575 — APNEALINK PLUS, MODEL: 22328
- K083675 — POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
- K083697 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M
- K083801 — BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
- K083825 — EOI SPINAL SYSTEM
- K083873 — PICC (CT RATED AND NON-RATED)
- K083892 — FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
- K090108 — HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
- K090128 — TAC-TITE (TM)
- K090481 — DEMASQ IMAGING SPFTWARE DEVICE
- K090524 — GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV
- K090537 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K081554 — TOKUYAMA TISSUECARE
- K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
- K083433 — INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601
- K083444 — C-REACTIVE PROTEIN (LATEX)
- K083490 — BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
- K083688 — PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
- K083823 — SECURIAN TISSUE REINFORCEMENT MATRIX
- K083909 — SPINAL INJECTION SYSTEM
- K090137 — STAK-CHEX PLUS RETICS
- K090272 — SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
- K090547 — ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
- K090562 — SMITH & NEPHEW INSTRUMENT TRAYS
- K083478 — SMOOTHLIPO
- K083858 — BOND BONE
- K090076 — SALTO TALARIS TOTAL ANKLE PROSTHESIS
- K090141 — PRONTOSAN ANTIMICROBIAL WOUND GEL
- K090235 — ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
- K090322 — EASY MOVING PLUS, SM-XXHF-YY
- K081709 — OLYMPUS AFP - ALPHA-FETOPROTEIN
- K081830 — IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1
- K081845 — IVENT101
- K082346 — VITEK 2 GRAM NEGATIVE DORIPENEM
- K083295 — SERIM DISINTEK GTA 2.1%, MODEL: 5164
- K083615 — EUROIMMUN ANTI BP 180-4X ELISA (IGG)
- K083763 — ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
- K083832 — ZEST NASAL MASK
- K090267 — SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
- K090514 — VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES
- K090552 — UROCARE
- K090590 — VERADIUS, MODEL 718-130
- K090597 — FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
- K080404 — EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
- K082345 — OXYGEN DEMAND VALVE
- K082735 — STONE GRASPING BASKET, MODEL PD-T1 2115
- K083073 — THEKEN ATOLL CERVICO-THORACIC SYSTEM
- K083142 — PICASSO LASER SYSTEM
- K083188 — VARELISA RECOMBI ANA SCREEN, MODEL 12 596
- K083263 — SYMCARE DIABETES MANAGEMENT PROGRAM
- K083316 — 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
- K083463 — DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
- K083518 — ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
- K083526 — TRILOGY 100 VENTILATOR
- K083651 — REVELATION STEM, MODEL 427-21/42-080/180
- K083919 — AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
- K090020 — BEL-CYPHER, MODEL Y977
- K090095 — LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
- K090214 — VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
- K090229 — DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV
- K090380 — MAGNUM M FIXATION DEVICE
- K090610 — HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
- K081740 — HEMOBAND, MODELS HB-NS AND HB-NSXL
- K081813 — UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM
- K081953 — SUPERCATH 5
- K083062 — ROOT CANAL XR
- K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II
- K083388 — SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
- K090168 — AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
- K081970 — BIOCLEAN CHEMO SHIELD
- K082190 — BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
Data sourced from openFDA. This site is unofficial and independent of the FDA.