FDA 510(k) clearances — page 474
clearances on record, most recent first.
Clearances — page 474
47,301–47,400 of 176,542- K111633 — AQUILION LB MOVEMENT BASE KIT
- K112104 — ELECSYS N-MID OSTEOCALCIN CALCHECK 5
- K112112 — SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
- K102511 — MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
- K103706 — THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
- K103719 — LIFECARE CONDUCTIVE GARMENTS
- K110031 — HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
- K110621 — SHENGKUN CHEMICAL
- K110776 — DIGITAL THERMOMETER MT SERIES
- K111293 — SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
- K111439 — CHESAPEAKE (CERVICAL COMPONENTS)
- K111525 — PERIMETER INTERBODY FUSION DEVICE
- K111528 — PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
- K111805 — ECG SERIES ELECTROCARDIOGRAPH
- K111917 — NUVANT, MOBILE CARDIAC TELEMETRY
- K112089 — BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
- K093915 — DEKA TAC DEVICE
- K102406 — PASS ANTERIOR SPINAL SYSTEM
- K110016 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K110828 — DDRELEMENT
- K111072 — BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
- K111207 — RESPIRE BLUE SERIES
- K111373 — CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
- K111502 — STREAMLINE TL SPINAL SYSTEM
- K111507 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K111589 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG
- K111620 — SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS
- K111741 — INTEGRA(TM) CUSA NXT(TM) BONE TIPS
- K110342 — YOLO CURVE
- K110584 — ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
- K111254 — RELIEVA SOLO ELITE SINUS BALLOON CATHETER
- K111352 — TALON DISTALFIX PROXIMAL FEMORAL NAIL
- K111609 — BOSTON BAND
- K100874 — LIPOSONIX SYSTEM, MODEL 1 P00XXXX
- K102315 — STAXX XDL SYSTEM
- K102706 — CKMB UDR ASSAY
- K102785 — TRIMED RADIOCARPAL FUSION SYSTEM
- K102831 — RSI 4200
- K103027 — ELECTROTORQUE TLC
- K103734 — POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
- K110172 — SONAFINE WOUND DRESSING
- K110301 — SILK'N FX
- K110316 — INFOSEND GSM
- K110689 — INBODY
- K110757 — TL-CERMIDE SKIN BARRIER EMULSION
- K110795 — V200 INTELLI-TRAK OPTION
- K110879 — BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
- K111365 — VITALA CONTINENCE CONTROL DEVICE
- K111432 — EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
- K111441 — UNIMAX VERESS NEEDLE
- K111508 — TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
- K111550 — SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
- K111616 — E-CUBE
- K111628 — P200T
- K111661 — ARTHREX SCAPHOLUNATE ANCHOR
- K111668 — CAVIOS CAVITY LINER
- K111698 — PROFEMUR(R) E CEMENTLESS HIP STEM
- K111699 — PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
- K111799 — NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
- K111952 — ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
- K111957 — POLARIS SPINAL SYSTEM
- K112108 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K112124 — MICROCATHETER
- K112231 — LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
- K102394 — AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM
- K103274 — SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
- K103659 — CS 9300, CS 9300C
- K103673 — GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
- K103790 — ACE TRIMARK TRICAM DENTAL IMPLANT
- K110076 — REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
- K110296 — AXIS-SHIELD ANTI-CCP
- K110598 — SMR REVERSE SHOULDER SYSTEM
- K110656 — IMC BLOOD COLLECTION NEEDLE
- K110882 — IMC INSULIN SYRINGE
- K111106 — TRUEBEAM
- K111167 — XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
- K111429 — SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
- K111807 — MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
- K112020 — SYNGO.CT VASCULAR ANALYSIS
- K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
- K110736 — ADVIA CHEMISTRY FERRITIN (FRT) METHOD
- K111083 — PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
- K111135 — PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
- K111284 — FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
- K111449 — REVOLVE ADDITIONAL IMPLANTS
- K111479 — REVERE CROSSTOP
- K111594 — ZOLL E SERIES
- K111881 — VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
- K111900 — NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
- K111987 — FIBERNET EMBOLIC PROTECTION DEVICE
- K112281 — GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX
- K112308 — CROSSER RECANALIZATION SYSTEM
- K101973 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
- K110397 — TRUMATCH PERSONALIZED SOLUTIONS
- K111145 — ENDO HEAD
- K111714 — HAIRMAX DUAL 12
- K103735 — MEDILED MINI
- K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN
- K111176 — OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
- K111247 — CRANIAL REMOLDING ORTHOSIS
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