FDA 510(k) clearances — page 782
clearances on record, most recent first.
Clearances — page 782
78,101–78,200 of 175,825- K012900 — ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
- K013137 — ALGO 3 NEWBORN HEARING SCREENER
- K013159 — HRH-63-8 HEAD ARRAY COIL
- K013176 — MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
- K013215 — MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
- K013235 — MODIFICATION TO SYNCHRON CONTROL
- K013322 — HAC-420 HEAD ARRAY COIL
- K002512 — TORAYSULFONE DIALYZER
- K010997 — PAM-RL
- K011283 — MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- K012237 — MERTEX-PLUS REUSABLE SURGICAL DRAPE
- K012240 — MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
- K012358 — CHIBA NEEDLE
- K012384 — EAR MUFFINS
- K012595 — ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
- K012641 — FAS ENDOLUMINAL BRUSH
- K012649 — RAICHEM BUN RATE REAGENT
- K012668 — RAICHEM GLUCOSE UV REAGENT
- K013026 — POWDERED LATEX EXAMINATION GLOVES
- K013118 — MODIFICATION TO ALPHA DX SYSTEM
- K013121 — MT ALERT INFUSION MONITOR
- K013134 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
- K013164 — SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
- K004005 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
- K010613 — MAGELLAN-2200, MODEL 1
- K010615 — CYCLOTEC AMT CTI TENS DEVICE
- K011373 — INSTRUMENT DAMPING PORT
- K011470 — SDI SB OFFICE, MODEL 29-
- K012206 — ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
- K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
- K012402 — OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
- K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
- K012425 — BIOMEDICS UV MULTIFOCAL
- K012883 — ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
- K013057 — BIOCUFF,C, MODELS 236018, 236028, 236036
- K013179 — LUXAGLAZE
- K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
- K013286 — CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA
- K003811 — CRYOCARE SURGICAL SYSTEM
- K010869 — EPOCA CUSTOM OFFSET SHOULDER SYSTEM
- K011080 — BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
- K012315 — LEVEEN ELECTRODE
- K012807 — MODIFICATION TO: COMPEL SURGICAL DRAPES
- K012935 — THECURVE, ITEM 507
- K013043 — CANDELA CLEARBEAM PULSED DYE LASER
- K010528 — TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
- K010985 — GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
- K012011 — MODIFICATION TO A620 EEG
- K012065 — WIENER LAB. CREATININA CINETICA AA
- K012172 — DURACON PS LIPPED TIBIAL INSERT
- K012263 — MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
- K012264 — MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
- K012354 — SNOWPOST, SNOWLIGHT
- K012464 — HELIX HYDRO-JET
- K013042 — DISCOVERY ELBOW
- K013129 — RHODIA DENTAL PUTTY IMPRESSION MATERIAL
- K013140 — RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
- K013194 — UNIMARK HCG COMBO PREGNANCY TEST
- K010016 — MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
- K010477 — AUTO-LOCK
- K010954 — CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
- K011021 — LASER 20
- K012230 — PHEM-ALERT
- K012367 — VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
- K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
- K012485 — MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
- K012508 — MU PHOTONICS PAIN THERAPIST
- K012509 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
- K012518 — TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
- K012886 — CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
- K012906 — ANIMEC, MODELS AM-2S-4 AND AM-2S-5
- K012928 — ABI VEST AIRWAY CLEARANCE SYSTEM
- K013029 — SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515
- K013294 — MONARCH SPINAL SYSTEMS
- K013295 — TIMX SPINAL SYSTEMS
- K013296 — MOSS MIAMI SPINAL SYSTEMS
- K991810 — MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
- K003431 — ZEUS ROBOTIC SURGICAL SYSTEM
- K003661 — SOCRATES ROBOTIC TELEMONITORING SYSTEM
- K010127 — W & H ASSISTINA
- K010706 — THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
- K011349 — INTERCOSTAL LOCKABLE-DIRECTABLE PORT
- K012140 — COM-PATCH
- K012505 — SOPRO595 INTRA ORAL CAMERA
- K012629 — ALWAYS DUETS
- K012971 — ISOLA SPINAL SYSTEMS
- K012993 — MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K013039 — INION CPS 2.0 ORTHOGNATHIC PLATE
- K013142 — DIASUS
- K013214 — CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
- K002839 — END EXPIRATORY FILTER, MODEL RT020
- K004001 — MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
- K010396 — C. NET 2100
- K010715 — AL-40
- K010804 — MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS
- K012127 — PULSEMASTER ERBIUM DENTAL LASER SYSTEM
- K012142 — THE QUIET SLEEPER
- K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K012525 — THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
- K012710 — DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.