FDA 510(k) clearances — page 466
clearances on record, most recent first.
Clearances — page 466
46,501–46,600 of 175,770- K111374 — SONO-SERIES CORNERSTONE TECHNIQUE
- K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
- K111572 — NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
- K111608 — SLIC SCREW REPAIR SYSTEM
- K112339 — ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
- K112341 — SNAP WOUND CARE SYSTEM
- K112409 — MATRISTEM WOUND MATRIX
- K102678 — ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
- K103087 — COVAMAX RESORBABLE COLLAGEN MEMBRANE
- K103181 — ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
- K103532 — AUTOREADER 2
- K110269 — WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
- K110451 — ENDOWRIST ONE SUCTION/IRRIGATOR
- K111301 — INSTINCT JAVA SYSTEM
- K111535 — EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
- K111573 — MONOBLOC BM SERIES
- K112137 — COMFORTGLIDE INTERMITENT CATHETER
- K112182 — ANGIOSCULPT PTA SCORING BALLOON CATHETER
- K112235 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
- K101234 — VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
- K102926 — GEMORE MUSCLE CONDITIONER;
- K110733 — DAYTONA ANTERIOR CERVICAL CAGE
- K110934 — ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
- K110977 — VESOFLOW
- K111101 — NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
- K111482 — SONICATOR PLUS 920
- K111584 — XYLOS MACRO-POROUS SURGICAL MESH
- K111592 — YOULASER CO2 LASER SYSTEM
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.