FDA 510(k) clearances — page 455
clearances on record, most recent first.
Clearances — page 455
45,401–45,500 of 175,770- K113040 — CERAMIR CROWN & BRIDGE
- K113283 — NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS
- K113317 — LIFECHOICE OXYGEN CONCENTRATOR
- K112387 — PROCEDURE REHEARSAL STUDIO(TM)
- K112546 — O_TWO CPAP SYSTEM
- K112575 — GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO
- K112822 — SLEEPSTRIP II
- K112923 — SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
- K112933 — ACCESS THYROGLOBULIN ANITBODY
- K110313 — TINA-QUANT HBA1C GEN.2
- K110717 — KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
- K110726 — ROCHE ACETAMINOPHEN ASSAY
- K111673 — 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
- K111680 — DR. GREENSBURG'S HYBRID
- K112352 — GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
- K112412 — AU5800(R) CHEMISTRY ANALYZER
- K112499 — BIOMERIX COMPOSITE SURGICAL MESH
- K112567 — BIOMERIX ASSURE
- K112664 — ZAVATION IBF SYSTEMS
- K112789 — EASY TOUCH
- K112799 — MED-RX EXTENSION SET WITH T-CONNECTOR
- K112901 — EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K113109 — STRYKER RESORBABLE FIXATION SYSTEM
- K113443 — 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
- K110198 — BLUE SKY BIO TCP
- K110381 — CELL-DYN EMERALD 22 SYSTEM
- K110798 — SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
- K111159 — HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
- K111204 — CELL-DYN 22 PLUS CALIBRATOR
- K111211 — CELL-DYN 22 PLUS CONTROL
- K111324 — CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
- K111617 — PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
- K111919 — IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
- K112041 — KOO SMALL VOLUME NEBULIZER (SVN)
- K112109 — THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE
- K112172 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY
- K112216 — U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
- K112423 — COLLAGEN TENDON SHEET
- K112515 — PENCAN SPINAL NEEDLE
- K112776 — TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
- K112783 — MANUJET III
- K112907 — CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
- K113140 — VARI-LASE WIREFIBER LASER FIBER
- K113244 — SYNAPSE MPR FUSION
- K113591 — COLS PEEK
- K110794 — AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
- K111055 — GALAXY SYSTEM; JUPITER
- K111303 — DERMATOLOGICAL TREATMENT DEVICE FAMILY
- K111446 — SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
- K112274 — U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
- K112302 — PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
- K112317 — FM-9000 PLUS FETAL AND MATERNAL MONITOR
- K112437 — ARTHREX FRACTURE SYSTEM
- K112506 — XPRESS MULTI-SINUS DILATION TOOL
- K112521 — FUKUDA DENSHI VASERA MODEL VS-1500
- K112657 — AUREFLO MONITORING SYSTEM
- K112920 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K113044 — SYNTHES MIRS
- K113075 — EMBRYO VIEWER SOFTWARE
- K113176 — MYSENSE HEART
- K113251 — SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
- K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K113444 — N-HYBRIDE-COMPOSITE LC FLOW
- K113479 — OPTIMEDICA CATALYS PRECISION LASER SYSTEM
- K113493 — TCX-I REMOTE CARE MANAGEMENT SYSTEM
- K113563 — N-HYBRIDE-COMPOSITE LC
- DEN100013 — VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50
- K101926 — FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
- K102499 — DUOFERTILITY
- K102921 — ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES
- K103022 — KIM
- K103508 — UNMIAX LAPAROSCOPIC INSTRUMENT
- K103554 — METRON-CP/MD
- K112102 — MICHELE SLEEP SCORING SYSTEMS
- K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
- K112941 — LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
- K113004 — PDS(TM) BARBED SUTURES
- K113028 — MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
- K113043 — DIRECT ANTIBIOTIC INFUSION KIT
- K113136 — 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
- K113399 — IFS SUBTALAR IMPLANT
- K113468 — ELM PTA BALLON DILATATION CATHETER
- K113523 — LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
- K113528 — CLYDESDALE(R) SPINAL SYSTEM
- K113534 — HEALIX KNOTLESS ANCHOR
- K113598 — POWER-LOAD COT FASTENER SYSTEM
- K102851 — NOFACT VIII
- K102908 — NOFACT IX
- K110895 — ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
- K111013 — ACEM
- K111831 — MX-7000 MICROXEL
- K112056 — ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
- K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
- K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
- K112704 — LIPIFLOW THERMAL PULSATION SYSTEM
- K112862 — MECTA-C
- K112885 — ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
- K112926 — AXSOS LOCKING PLATE SYSTEM
- K112990 — ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
- K113434 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.