FDA 510(k) clearances — page 560
clearances on record, most recent first.
Clearances — page 560
55,901–56,000 of 175,825- K081643 — DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
- K081734 — SYNGO IMAGING (VERSION V31)
- K071074 — MYKRES SPINAL SYSTEM
- K071446 — ELECTRODE ARRAY CAP
- K071668 — ORTHOBIOM SPINAL SYSTEM
- K072678 — LAGUNA SIZE 8 PEDICLE SCREW
- K073303 — NORIAN DRILLABLE
- K080319 — KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K080822 — VU APOD INTERVERTABRAL BODY FUSION DEVICE
- K080971 — SPINESMITH CIMPLICITY SPINAL SYSTEM
- K080991 — DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
- K081125 — WRIST PULSE OXIMETER MD300W
- K081300 — DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
- K081383 — RELIANCE VBS SYSTEM
- K081501 — SOLITAIRE ANTERIOR SPINAL SYSTEM
- K081565 — INTEGRE PRO, MODEL L2RY
- K081597 — MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
- K081609 — CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
- K081676 — SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM
- K072901 — AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
- K072968 — STRESSGARD NIGHTGUARD
- K080695 — MOBILE I.V. SYSTEMS 10,20,60
- K080813 — PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
- K080915 — FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
- K080916 — CAPILLARYS URINE
- K080974 — TLS FIXATION SYSTEM
- K081205 — SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
- K081263 — STARCERAM
- K081637 — LASER IMAGER DRYPRO MODEL 873
- K072854 — DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
- K073225 — SENSEI CATHETER CONTROL SYSTEM
- K080073 — S-TEST CREATININE (CRE)
- K080100 — WATCHHALER
- K080379 — MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
- K080537 — L-VARLOCK
- K080657 — NEB-90 LARGE VOLUME MEDICATION NEBULIZER
- K081027 — KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
- K081219 — APOLLO MINI IPL SYSTEM
- K081411 — VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
- K081564 — CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION
- K081620 — MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
- K071984 — MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
- K072182 — ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
- K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
- K073631 — ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
- K073644 — ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
- K080283 — IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
- K080497 — DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
- K080604 — PRESSURE INJFECTABLE PICC
- K080617 — POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
- K080679 — MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
- K080798 — INTEL HEALTH GUIDE, MODEL: PHS6000
- K080828 — MOUNTAINEER OCT SPINAL SYSTEM
- K080955 — ZEN PROGRAM (MIND 440 HEARING AID)
- K080959 — DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
- K081041 — GPS, G SURGICAL PEDICLE SYSTEM
- K081049 — FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
- K081243 — BIOMET PHOENIX ANKLE NAIL SYSTEM
- K081473 — HERO, VERSION 2.0
- K081542 — MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
- K081555 — TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
- K081573 — MEDTRONIC EXPORT AP CATHETER
- K081665 — MILLENIUM II
- K072142 — S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
- K072962 — CABS'AIR
- K073223 — S-TEST C02
- K073702 — PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
- K080734 — FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
- K081146 — ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
- K081362 — PLATELIA LYME IGM
- K081467 — EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
- K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
- K080381 — QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
- K080600 — ULTIMED ULTICARE SAFETY SYRINGE
- K080812 — HEMOCCULT ICT
- K080962 — LITE WAND II
- K081395 — SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
- K081483 — XTAG RESPIRATORY VIRAL PANEL
- K081533 — SENTINEL PLASMAPROTEINS CAL 3X
- K081612 — AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS
- K081634 — CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL
- K072140 — S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
- K072141 — S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
- K072326 — OSTAPEK VBR SYSTEM
- K072356 — S-TEST CA
- K072861 — CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
- K073556 — MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
- K080181 — MODIFICATION TO GALILEO GOLD
- K080197 — PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
- K080223 — ZURA TEE SYSTEM
- K080639 — SYMPHONY GLUCOSE MANAGEMENT SYSTEM
- K080816 — VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
- K080879 — ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
- K080886 — IPLAN RT IMAGE
- K081160 — AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
- K081471 — ECARD AND CCARD
- K081648 — DIGITAL RADIOGRAPHY CXDI-60G
- K081661 — HD15 DIAGNOSTIC ULTRASOUND SYSTEM
- K063261 — NUCLISENS EASYQ ENTEROVIRUS SYSTEM
- K073280 — BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
Data sourced from openFDA. This site is unofficial and independent of the FDA.